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32
29,508,661
Cemented and uncemented tibial components had different migration patterns . For cemented tibial components there was no difference in migration between all-poly and metal-backed components , between mobile bearing and fixed bearing , between cruciate retaining and posterior stabilized . Furthermore , no difference existed between TKR measured with model-based RSA or marker-based RSA methods . For uncemented TKR there was some variation in migration with the highest migration for uncoated TKR . Interpretation - The results from this meta- analysis on RSA migration of TKR are in line with both the survival analyses results from joint registries of these TKRs as well as revision rates results from meta-analyses , thus providing further proof for the association between early migration and late revision for loosening .
Purpose - We performed a systematic review and meta-analyses to evaluate the early and long-term migration patterns of tibial components of TKR of all known RSA studies .
600
9,880,180
Ceramic coating improves tibial component fixation in total knee arthroplasty.
Forty uncemented total knee arthroplasties ( 36 patients ) were r and omly allocated to a Miller-Galante II prosthesis with or without hydroxyapatite/tricalcium phosphate ( HA/TCP ) coating on the titanium fiber mesh on the undersurface of the tibial component . The patients were followed for 2 years with repeated radiostereometric examinations . After 2 years , the HA/TCP tibial components displayed smaller anterior-posterior tilt and less subsidence . The mean value of maximal total point motion was small : 0.5 mm in both groups . At 24 months , there were more radiolucent lines under the tibial tray and around the stem in the uncoated group , but the clinical results did not differ . HA/TCP coating on the undersurface of the tibial component improved the stability and seemed to improve the quality of the interface between the tibial component and the bone
32
Cemented and uncemented tibial components had different migration patterns . For cemented tibial components there was no difference in migration between all-poly and metal-backed components , between mobile bearing and fixed bearing , between cruciate retaining and posterior stabilized . Furthermore , no difference existed between TKR measured with model-based RSA or marker-based RSA methods . For uncemented TKR there was some variation in migration with the highest migration for uncoated TKR . Interpretation - The results from this meta- analysis on RSA migration of TKR are in line with both the survival analyses results from joint registries of these TKRs as well as revision rates results from meta-analyses , thus providing further proof for the association between early migration and late revision for loosening .
Purpose - We performed a systematic review and meta-analyses to evaluate the early and long-term migration patterns of tibial components of TKR of all known RSA studies .
32
29,508,661
Cemented and uncemented tibial components had different migration patterns . For cemented tibial components there was no difference in migration between all-poly and metal-backed components , between mobile bearing and fixed bearing , between cruciate retaining and posterior stabilized . Furthermore , no difference existed between TKR measured with model-based RSA or marker-based RSA methods . For uncemented TKR there was some variation in migration with the highest migration for uncoated TKR . Interpretation - The results from this meta- analysis on RSA migration of TKR are in line with both the survival analyses results from joint registries of these TKRs as well as revision rates results from meta-analyses , thus providing further proof for the association between early migration and late revision for loosening .
Purpose - We performed a systematic review and meta-analyses to evaluate the early and long-term migration patterns of tibial components of TKR of all known RSA studies .
601
7,863,762
The stability of three different cementless tibial components. A randomized radiostereometric study in 45 knee arthroplasty patients.
We conducted a prospect i ve , r and omized study of 45 patients to evaluate 3 different uncemented tibial component design s in total knee arthroplasty . The stability of the components was assessed by radiostereometry ( RSA ) , both as migration during 2 years and as inducible displacement at 2 years . The PCA resurfacing , the Tricon stem and the Tricon-M prosthesis groups showed a similar level of migration at 2 years , about 1.4 mm . In response to externally applied rotatory forces , the Tricon groups rotated more than the PCA group , interpreted as a consequence of the more conforming articular surface in the Tricon design . The series was divided into one group of continuously migrating prostheses with a poor prognosis ( unstable , one third ) and another group of prostheses in which migration stopped after 1 year ( stable , two thirds ) . With this classification , no differences between the prostheses design groups were revealed . However , the unstable group showed a larger inducible displacement by provocation , an association hitherto not established
32
Cemented and uncemented tibial components had different migration patterns . For cemented tibial components there was no difference in migration between all-poly and metal-backed components , between mobile bearing and fixed bearing , between cruciate retaining and posterior stabilized . Furthermore , no difference existed between TKR measured with model-based RSA or marker-based RSA methods . For uncemented TKR there was some variation in migration with the highest migration for uncoated TKR . Interpretation - The results from this meta- analysis on RSA migration of TKR are in line with both the survival analyses results from joint registries of these TKRs as well as revision rates results from meta-analyses , thus providing further proof for the association between early migration and late revision for loosening .
Purpose - We performed a systematic review and meta-analyses to evaluate the early and long-term migration patterns of tibial components of TKR of all known RSA studies .
32
29,508,661
Cemented and uncemented tibial components had different migration patterns . For cemented tibial components there was no difference in migration between all-poly and metal-backed components , between mobile bearing and fixed bearing , between cruciate retaining and posterior stabilized . Furthermore , no difference existed between TKR measured with model-based RSA or marker-based RSA methods . For uncemented TKR there was some variation in migration with the highest migration for uncoated TKR . Interpretation - The results from this meta- analysis on RSA migration of TKR are in line with both the survival analyses results from joint registries of these TKRs as well as revision rates results from meta-analyses , thus providing further proof for the association between early migration and late revision for loosening .
Purpose - We performed a systematic review and meta-analyses to evaluate the early and long-term migration patterns of tibial components of TKR of all known RSA studies .
602
16,026,700
VersaBond bone cement prospective randomized study of the clinical properties of a new bone cement in total knee replacement.
VersaBond is a newly developed bone cement . To investigate its clinical performance , VersaBond was compared to Palacos R in a prospect i ve r and omized study in total knee replacement . Fifty-nine patients ( 61 knees ) undergoing total knee replacement were r and omized to either VersaBond or Palacos R bone cement and followed for 24 months using radiostereometric analysis ( RSA ) . Up to 2 years there were no significant differences in clinical performance between the two cements . The mean/median values for implant migration were very similar for the two bone cements , as were the dispersion , and distribution of outliers . Also the proportion " stable " and " continuously migrating " implants was similar between the two cements . The result of this study indicates that VersaBond bone cement will perform at least equally as well as Palacos R in total knee replacement as regards as aseptic loosening
32
Cemented and uncemented tibial components had different migration patterns . For cemented tibial components there was no difference in migration between all-poly and metal-backed components , between mobile bearing and fixed bearing , between cruciate retaining and posterior stabilized . Furthermore , no difference existed between TKR measured with model-based RSA or marker-based RSA methods . For uncemented TKR there was some variation in migration with the highest migration for uncoated TKR . Interpretation - The results from this meta- analysis on RSA migration of TKR are in line with both the survival analyses results from joint registries of these TKRs as well as revision rates results from meta-analyses , thus providing further proof for the association between early migration and late revision for loosening .
Purpose - We performed a systematic review and meta-analyses to evaluate the early and long-term migration patterns of tibial components of TKR of all known RSA studies .
32
29,508,661
Cemented and uncemented tibial components had different migration patterns . For cemented tibial components there was no difference in migration between all-poly and metal-backed components , between mobile bearing and fixed bearing , between cruciate retaining and posterior stabilized . Furthermore , no difference existed between TKR measured with model-based RSA or marker-based RSA methods . For uncemented TKR there was some variation in migration with the highest migration for uncoated TKR . Interpretation - The results from this meta- analysis on RSA migration of TKR are in line with both the survival analyses results from joint registries of these TKRs as well as revision rates results from meta-analyses , thus providing further proof for the association between early migration and late revision for loosening .
Purpose - We performed a systematic review and meta-analyses to evaluate the early and long-term migration patterns of tibial components of TKR of all known RSA studies .
603
26,162,514
Absence of a Tourniquet Does Not Affect Fixation of Cemented TKA: A Randomized RSA Study of 70 Patients.
We aim ed to determine whether not using a tourniquet in cemented TKA would affect migration of the tibial component measured by radiosterometric analysis ( RSA ) . Seventy patients were r and omized into a tourniquet group and a non-tourniquet group and using model-based RSA , the migration of the tibial component was analyzed . Primary and secondary outcome measures were maximum total point motion ( MTPM ) and translations and rotations . Follow-up period was 2 years . The tibial component was well fixated in both groups and no significant difference in migration between the two groups was detected ( P=0.632 ) . Mean MTPM ( SD ) was 0.47 mm ( 0.16 ) in the tourniquet group and 0.45 mm ( 0.21 ) in the non-tourniquet group . Absence of tourniquet indicates that stable fixation of the tibial component can be achieved in cemented TKA
32
Cemented and uncemented tibial components had different migration patterns . For cemented tibial components there was no difference in migration between all-poly and metal-backed components , between mobile bearing and fixed bearing , between cruciate retaining and posterior stabilized . Furthermore , no difference existed between TKR measured with model-based RSA or marker-based RSA methods . For uncemented TKR there was some variation in migration with the highest migration for uncoated TKR . Interpretation - The results from this meta- analysis on RSA migration of TKR are in line with both the survival analyses results from joint registries of these TKRs as well as revision rates results from meta-analyses , thus providing further proof for the association between early migration and late revision for loosening .
Purpose - We performed a systematic review and meta-analyses to evaluate the early and long-term migration patterns of tibial components of TKR of all known RSA studies .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
604
18,558,168
Resource utilization and outcomes from percutaneous drainage and interval appendectomy for perforated appendicitis with abscess.
OBJECTIVE Given the perceived technical dem and s of laparoscopic appendectomy and the expected postoperative morbidity in patients with a well-defined abscess , initial percutaneous drainage has become an attractive option in this patient population . This strategy allows for a laparoscopic appendectomy to be performed in an elective manner at the convenience of the surgeon . However , the medical burden on the patient and on the quality of patient outcomes has not been described in the literature . Therefore , we audited our experience with initial percutaneous drainage followed by laparoscopic interval appendectomy to evaluate the need for a prospect i ve trial . METHODS After institutional review board approval , a retrospective chart review was performed on all children who presented with perforated appendicitis and a well-defined abscess and were treated by initial percutaneous aspiration/drainage followed by interval appendectomy between January 2000 and September 2006 . Continuous variables are listed with st and ard deviation . RESULTS There were 52 patients with a mean age of 9.0 + /- 3.9 years and weight of 34.4 + /- 18.8 kg . The mean duration of symptoms at presentation was 8.4 + /- 7.6 days . Percutaneous aspiration only was performed in 2 patients . The mean volume of fluid on initial aspiration/drain placement was 76.3 + /- 81.1 mL. The mean time to appendectomy was 61.9 + /- 25.2 days . The laparoscopic approach was used in 49 patients ( 94.2 % ) , of which one was converted to an open operation . The mean length of hospitalization after interval appendectomy was 1.4 + /- 1.4 days . A recurrent abscess developed in 17.3 % of the patients . Six patients ( 11.5 % ) required another drainage procedure . The mean total charge to the patients was $ 40,414.02 . There were 4 significant drain complications ( ileal perforation , colon perforation , bladder perforation , and buttock/thigh necrotizing abscess ) . The child with the ileal perforation after drain placement is the only patient who failed initial nonoperative therapy . CONCLUSIONS The use of initial percutaneous aspiration/drainage of periappendiceal abscess followed by interval appendectomy is an effective approach . However , this management poses complication risks and uses considerable re sources . Therefore , this strategy should be compared with early operation in a prospect i ve trial
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
605
20,965,290
Evaluation of early surgical management of complicated appendicitis by appendicular mass.
AIM This prospect i ve study was done to evaluate the feasibility and safety of immediate appendicectomy in the presence of appendicular mass . METHODS A prospect i ve , nonr and omized study was conducted over 46 consecutive patients ( mean age : 24 ± 8.76 years ) presenting with an appendicular mass over a 4-year period . They were subjected for immediate appendicectomy within 24 h of admission . RESULTS The appendix was identified and removed in all 46 patients at operation . Peri-appendiceal abscesses were present in 25 % ( 11 of 46 ) . There was difficulty with adhesolysis and localization of the appendix in 10%(4 ) of patients . Superficial wound infection had occurred in 8(17 % ) while deep wound infection had occurred in 9%(4 ) patients . The mean hospital stay was 3 ± 0.25 day . No major complications had occurred . CONCLUSIONS Early surgical intervention in patients with an appendicular mass is feasible , safe and avoids the consequences of the misdiagnosis and mistreatment of other surgical pathologies
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
606
15,747,071
Long-Term Outcome of Mesocolic and Pelvic Diverticular Abscesses of the Left Colon: A Prospective Study of 73 Cases
PURPOSE The aim of of this study was to evaluate prospect ively the long-term outcome of mesocolic and pelvic diverticular abscesses of the left colon . METHODS Between October 1986 and October 1997 , a total of 465 patients urgently admitted to our hospital with a suspected diagnosis of acute left-sided colonic diverticulitis had a CT scan . Of 76 patients ( 17 percent ) who had an associated mesocolic or pelvic abscess , 3 were lost to follow-up . The remaining 73 patients ( 45 with a mesocolic abscess and 28 with a pelvic abscess ) were followed for a median of 43 months . RESULTS of the 45 patients with a mesocolic abscess , 7 ( 15 percent ) required surgery during their first hospitalization versus 11 ( 39 percent ) of the 28 patients with a pelvic abscess ( P = 0.04 ) . At the end of follow-up , 22 ( 58 percent ) of the 38 patients with a mesocolic abscess who had successful conservative treatment during their first hospitalization did not need surgical treatment vs. 8 ( 47 percent ) of the 17 who had a pelvic abscess . Altogether , 51 percent of the patients with a mesocolic abscess had surgical treatment versus 71 percent of those with a pelvic abscess ( P = 0.09 ) . CONCLUSIONS Considering the poor outcome of pelvic abscess associated with acute left-sided colonic diverticulitis , percutaneous drainage followed by secondary colectomy seems justified . Mesocolic abscess by itself is not an absolute indication for colectomy
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
607
12,037,755
Prospective evaluation of nonsurgical versus surgical management of appendiceal mass.
PURPOSE Prospect i ve evaluation was undertaken of surgical findings , complications , morbidity , and hospital stay between initial nonsurgical management versus early surgical intervention of an appendicular mass . METHODS A prospect i ve , nonr and omized study was conducted of 82 consecutive patients ( mean age , 6.9 + /- 3.3 years ) presenting with an appendicular mass over a 5-year period . They were categorized as group 1 , 58.5 % ( 48 of 82 ) nonsurgically managed and an interval appendectomy performed at a mean period of 8.6 + /- 4.6 weeks and group 2 , 41.5 % ( 34 of 82 ) appendectomy at presentation . RESULTS An appendix was identified in all 82 patients in both groups at operation . In-group 1 , recurrent episodes of abdominal pain necessitated interval appendectomy in 39.6 % ( 19 of 48 ) patients at a mean 4.3 + /- 0.8 versus 11.5 + /- 3.7 weeks in 60.4 % ( 29 of 48 ) who underwent scheduled interval appendectomy . Periappendiceal abscesses present at interval appendectomy in group 1 was ( 38 of 48 ) 79.2 % versus 100 % ( 34 of 34 ) at appendectomy in group 2 . Adhesions at interval appendectomy in group 1 was 81.3 % ( 39 of 48 ) versus 100 % ( 34 of 34 ) at appendectomy in group 2 . In-group 1 , superficial wound infection was observed in 0 versus 4 wound infections in group 2 . Overall morbidity rate between group 1 and group 2 was statistically significant ( P < .05 ) . Total mean hospital stay in group 1 was 13.2 + /- 1.5 versus 4.8 + /- 0.4 days in group 2 . Of the 48-interval appendectomy specimens , 37 of 48 ( 77 % ) appendices had a patent lumen , and 11 of 48 ( 23 % ) showed fibrosis and obliteration of appendicular lumen . There was no correlation ( r = 0.22 ) between the histopathologic findings and the interval between abscess treatment and interval appendectomy . CONCLUSIONS Early surgical intervention was beneficial over nonoperative management in this cohort of patients . Interval appendectomy is recommended after nonsurgical management of an appendicular mass
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
608
21,142,385
Conservative approach versus urgent appendectomy in surgical management of acute appendicitis with abscess or phlegmon.
BACKGROUND Surgical management of acute appendicitis with appendiceal abscess or phlegmon remains controversial . We studied the results of initial conservative treatment ( antibiotics and percutaneous drainage if necessary , with or without interval appendectomy ) compared with immediate surgery . METHODS We undertook an observational , retrospective cohort study of patients with a clinical and radiological diagnosis of acute appendicitis with an abscess or phlegmon , treated in our hospital between January 1997 and March 2009 . Patients younger than 14 , with severe sepsis or with diffuse peritonitis were excluded . A study group of 15 patients with acute appendicitis complicated with an abscess or phlegmon underwent conservative treatment . A control group was composed of the other patients , who all underwent urgent appendectomy , matched for age and later r and omized 1:1 . The infectious risk stratification was established with the National Nosocomial Infections Surveillance System ( NNIS ) index . Dependent variables were hospital stay and surgical site infection . Analysis was with SPSS , with p < 0.05 considered significant . RESULTS Interval appendectomy was performed in 7 study group patients . Surgical site infection episodes were more frequent in the control group ( 6 vs. 0 , p < 0.001 ) . A greater percentage of high risk patients ( NNIS ≥ 2 ) was identified in the control group ( 80 vs. 28.7 % , p < 0.03 ) , mostly related with contaminated or dirty procedures in this group ( p < 0.001 ) . No significant difference between groups was found in hospital stay . CONCLUSION Initial conservative treatment should be considered the best therapeutic choice for acute appendicitis with abscess or phlegmon
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
609
22,513,434
Influence of Risk Factors on the Safety of Ileocolic Anastomosis in Crohn’s Disease Surgery
BACKGROUND : Ileocecal resection is the most commonly performed operation in patients with Crohn ’s disease . Anastomotic-associated complications , with their associated morbidity , are the most feared risks of surgery . OBJECTIVE : This study aim ed to assess the influence of a variety of putative risk factors in a homogenous group of patients undergoing first or subsequent surgery for Crohn ’s disease to quantify the cumulative risk for anastomotic-associated complications . DESIGN AND PATIENTS : All patients undergoing ileocecal or ileocolic resections for Crohn ’s disease from 2000 to 2010 were studied with the use of a prospect i ve data base . Demographics , operative details , possible risk factors , and anastomotic-associated complications were recorded . Patients having strictureplasties , multiple resections , or subtotal colonic resections were excluded from analysis . Statistical analysis was by univariate analysis ( Mann-Whitney U test ) and binary logistic regression . OUTCOMES : An anastomotic-associated complication was defined as a proven anastomotic leak , postoperative fistulation , or intra-abdominal abscess formation . RESULTS : Two hundred seven patients ( 109 female ) with a median age of 35 years ( range , 13 - 75 years ) were identified . One hundred seventy-three underwent primary anastomosis , 94 as an emergency procedure . Fifty-three had laparoscopic ( 5 converted ) procedures . Nineteen of 173 anastomotic complication events ( 11 % ) were recorded . Steroid usage ( OR 2.67 , 95 % CI 1.0 - 7.2 ) and the presence of preoperative abscess formation ( OR 3.4 , 95 % CI 1.2 - 9.8 ) were identified as independent predictors of anastomotic-associated complications . In the absence of both steroids and intra-abdominal abscess , the risk of anastomotic complications was 6 % , which increased to 14 % if either risk factor was present . When both risk factors were present , complication rates reached 40 % . CONCLUSION : Steroid usage and preoperative abscess were associated with higher rates of anastomotic complications following ileocolic resection for Cohn ’s disease . When both risk factors are present , it is best to avoid primary anastomosis
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
610
17,103,286
Comparison of therapeutic effectiveness of percutaneous drainage with antibiotics versus antibiotics alone in the treatment of periappendiceal abscess
Background The present study was design ed to compare the therapeutic effectiveness of percutaneous drainage with antibiotics versus antibiotics alone in the treatment of appendicitis complicated by periappendiceal abscess . Methods In a prospect i ve study , 50 patients with acute appendicitis complicated by periappendiceal abscess ≥ 3 cm in size were r and omly assigned to two groups . The first group received treatment with ultrasound guided-percutaneous drainage and i.v . antibiotics ( ampicillin , cefuroxime , and metronidazole ) , and the other group received antibiotics only . Patient ’s baseline characteristics , duration of hospital stay , and treatment outcome and complications were analyzed . Results Appendectomy was avoided in 16/25 patients in the drainage group and 2/25 patients in the non-drainage group during follow-up with RR of 0.39 ( 95 % CI = 0.22–0.62 ; p < 0.05 ) . One patient in the drainage group and 8 patients in the non-drainage group underwent surgery in the first month after the beginning of treatment . Eight patients in the drainage group and 15 in the non-drainage group underwent interval appendectomy . There was no statistically significant difference between the two groups regarding patient demographics , abscess size , and pretreatment clinical symptoms . Hospital stay up to the subsidence of clinical and sonographic signs was significantly shorter ( p < 0.001 ) in the drainage group , with a mean difference of 6.4 days ( 95 % CI = 5.0–7.9 ; p < 0.05 ) . Conclusions Percutaneous drainage with antibiotics is a safe and effective way of treating acute perforated appendicitis . The recurrence rate for these patients is relatively low , and very often interval appendectomy is not required . For patients with periappendiceal abscess ≥ 3 cm in diameter , antibiotic therapy alone is insufficient and the recurrence rate is high
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
611
7,944,037
Appendiceal mass: conservative therapy followed by interval laparoscopic appendectomy.
BACKGROUND Current therapy of patients with appendiceal abscess or phlegmon is in evolution . Controversial areas include initial conservative therapy , drainage of periappendiceal abscesses , and the role of interval appendectomy . OBJECTIVE To evaluate the safety and efficacy of conservative therapy and of interval laparoscopic appendectomy ( ILA ) . PATIENTS AND METHODS Patients with signs and symptoms of acute appendicitis and a palpable right lower quadrant mass were included . Abscess/phlegmon was documented with ultrasound or computerized tomography . After initial therapy with antibiotics , patients were discharged to home . ILA was performed 6 to 12 weeks later . RESULTS Twelve patients were included . Four patients had phlegmonous appendicitis and eight had an abscess , but only four had percutaneous drainage . All patients improved without surgical exploration and were subjected to ILA . ILA was successful in 11 of 12 patients ; a median hospital postoperative stay of 1 day was required , and no perioperative morbidity was encountered . All patients returned to routine activities within 2 weeks of surgery . CONCLUSIONS 1 ) Initial conservative management of patients with appendiceal abscess/phlegmon is prudent , safe , and effective . 2 ) Interval laparoscopic appendectomy can be performed safely and effectively
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
612
16,034,758
Is early laparoscopic appendectomy feasible in children with acute appendicitis presenting with an appendiceal mass? A prospective study.
BACKGROUND The management of an appendiceal mass remains controversial with 2 schools of thought ; early surgical intervention vs nonoperative management with or without interval appendectomy . The aim is to determine the role and safety of early laparoscopic appendectomy ( LA ) in children with acute appendicitis presenting with an appendiceal mass . METHODS This is a prospect i ve study of 88 consecutive pediatric patients who underwent attempted LA for suspected acute appendicitis at KK Women 's and Children 's Hospital , Singapore , between May and October 2003 . RESULTS A total of 88 patients with a mean age of 10 + /- 3 years ( range , 3 - 16 years ) underwent LA for an appendiceal mass ( n = 22 ) , simple appendicitis ( n = 36 ) , other complicated ( gangrenous or perforated ) appendicitis ( n = 23 ) , and a normal appendix ( n = 7 ) . There were 7 conversions to open appendicectomy , 3 of which occurred in patients with an appendiceal mass . There were no perioperative or postoperative mortalities . Morbidity occurred in only one patient who underwent LA for perforated appendicitis . He had prolonged sepsis that resolved after 2 weeks of intravenous antibiotics . None of the patients with an appendiceal mass developed complications . Patients who underwent early LA for an appendiceal mass had a statistically significant ( P < .05 ) longer operating time ( median , 103 minutes ; interquartile range , 90 - 151 minutes , vs median , 87 minutes ; interquartile range , 71 - 112 minutes ) , prolonged time to ambulation ( median , 2.0 days ; interquartile range , 2 - 2.5 days , vs median , 1.0 days ; interquartile , 1 - 2 days ) , increased time to resumption of diet ( median , 4 days ; interquartile , 3 - 5 days , vs median , 2 days ; interquartile , 2 - 3 days ) , and longer postoperative stay ( median , 6.0 days ; interquartile , 5.5 - 6.5 days , vs median , 4.0 days ; interquartile , 3 - 5.5 days ) compared with patients presenting with appendicitis without mass formation . However , there was no statistical difference in these parameters when LA for an appendiceal mass was compared with LA for other complicated appendicitis ( perforated and gangrenous ) . CONCLUSION Although early LA for an appendiceal mass is a technically dem and ing procedure , it can be performed safely in children with minimal morbidity and mortality . In an era where patients ' dem and for " key-hole " surgery is rising , early LA is a safe and viable option in the management of children with an appendiceal mass . It also offers the advantage of avoiding misdiagnoses and the need for a second hospitalization
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
613
8,324,675
Is a long delay necessary before appendectomy after appendiceal mass formation? A preliminary report.
The st and ard treatment for an appendiceal mass is conservative therapy followed by appendectomy after 6 to 10 weeks . With the advent of antibiotics design ed to prevent the growth of anaerobes , early appendectomy can now be carried out without complication . The authors studied 56 patients with appendiceal mass formation , 26 ( group A ) treated conventionally and 30 ( group B ) treated by early appendectomy . In group B , the infection rate was 17 % , the mean operating time was 38.7 minutes , the mean hospital stay was 15 days and there was an early return to work . The corresponding parameters for group A were an infection rate of 8 % , a mean operating time of 35.2 minutes , a hospital stay of 19.1 days and a late return to work . Furthermore , 15 % of the patients in group A had a recurrent acute episode during the waiting period . Overall , early appendectomy appears to be a safe and cost-effective treatment for appendiceal mass formation
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
614
20,105,610
Initial laparoscopic appendectomy versus initial nonoperative management and interval appendectomy for perforated appendicitis with abscess: a prospective, randomized trial.
INTRODUCTION Perforated appendicitis is a common condition in children , which , in a small number of patients , may be complicated by a well-formed abscess . Initial nonoperative management with percutaneous drainage/aspiration of the abscess followed by intravenous antibiotics usually allows for an uneventful interval appendectomy . Although this strategy has become well accepted , there are no published data comparing initial nonoperative management ( drainage/interval appendectomy ) to appendectomy upon presentation with an abscess . Therefore , we conducted a r and omized trial comparing these 2 management strategies . METHODS After internal review board approval ( # 06 11 - 164 ) , children who presented with a well-defined abdominal abscess by computed tomographic imaging were r and omized on admission to laparoscopic appendectomy or intravenous antibiotics with percutaneous drainage of the abscess ( when possible ) , followed by interval laparoscopic appendectomy approximately 10 weeks later . This was a pilot study with a sample size of 40 , which was based on our recent volume of patients presenting with appendicitis and abscess . RESULTS On presentation , there were no differences between the 2 groups regarding age , weight , body mass index , sex distribution , temperature , leukocyte count , number of abscesses , or greatest 2-dimensional area of abscess in the axial view . Regarding outcomes , there were no differences in length of total hospitalization , recurrent abscess rates , or overall charges . There was a trend toward a longer operating time in patients undergoing initial appendectomy ( 61 minutes versus 42 minutes mean , P = .06 ) . CONCLUSIONS Although initial laparoscopic appendectomy trends toward a requiring longer operative time , there seems to be no advantages between these strategies in terms of total hospitalization , recurrent abscess rate , or total charges
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
33
25,162,440
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
615
15,598,997
Treatment of appendiceal mass: prospective, randomized clinical trial.
BACKGROUND Appendiceal mass may be treated in several ways . However , no r and omized trial has been conducted to find the best option . OBJECTIVE To compare the three most commonly used methods for treating appendiceal mass . METHODS Over a three-year period , 60 consecutive patients with appendiceal mass were r and omly allocated to three groups : Group A -- initial conservative treatment followed by interval appendectomy six weeks later ; Group B -- appendectomy as soon as appendiceal mass resolved using conservative means ; Group C -- conservative treatment alone . Short-term outcome measures included operative time , operative difficulty , postoperative complications , length of hospital stay , and duration of time away from work . Long-term outcome measures were : number of hospital visits made , presence of severe incisional pain , scar appearance , and patients with recurrent appendicitis . RESULTS Baseline characteristics were comparable in the three groups . In patients in Group A , operative time was less , adhesions were encountered less frequently , the incision had to be extended less often and post-operative complications were fewer , as compared to Group B. Patients in Group C had the shortest hospital stay and duration of work-days lost ; only 2 of 20 patients in this group developed recurrent appendicitis during a follow-up period of 24 - 52 ( median 33.5 ) months . CONCLUSION Of the three treatment modalities compared , conservative treatment without subsequent appendectomy appears to be the best
33
Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .
INTRODUCTION The treatment strategy for appendiceal mass is controversial , ranging from operation or image-guided drainage to conservative treatment with or without antibiotics . The aim of this study was to assess the various treatment modalities with respect to complications and treatment failure .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
616
26,784,973
Placebo-controlled, randomised clinical trial: high-dose resveratrol treatment for non-alcoholic fatty liver disease
ABSTRACT Objective “ The obesity epidemic ” has led to an increase in obesity-related conditions including non-alcoholic fatty liver disease ( NAFLD ) , for which effective treatments are in dem and . The polyphenol resveratrol prevents the development of experimental NAFLD through modulation of cellular pathways involved in calorie restriction . We aim ed to test the hypothesis that resveratrol alleviates NAFLD in a r and omised , clinical trial . Material s and methods A total of 28 overweight patients with transaminasemia and histological NAFLD were r and omised 1:1 to placebo or resveratrol 1.5 g daily for 6 months . Twenty-six participants completed the trial and underwent repeated clinical investigation , blood work , MR spectroscopy ; and 19 participants agreed to a repeat liver biopsy . Results Resveratrol treatment was generally not superior to placebo in improving plasma markers of liver injury ( primary outcome : alanine transaminase , p = 0.51 ) . Resveratrol-treated patients showed a 3.8 % decrease in liver lipid content ( p = 0.03 ) , with no difference between the two treatment arms ( p = 0.38 ) and no improvement of histological features . Resveratrol treatment was not associated with improvements in insulin sensitivity or markers of the metabolic syndrome , except for a transient decrease in systolic BP . Microarray analysis and qRT-PCR revealed no major changes in expression profile . Also , we report a serious adverse event in a patient who developed fever and bicytopenia . Conclusions In this placebo-controlled , high-dose and long-term study , resveratrol treatment had no consistent therapeutic effect in alleviating clinical or histological NAFLD , though there may be a small ameliorating effect on liver function tests and liver fat accumulation
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
617
22,901,562
Resveratrol supplementation improves glycemic control in type 2 diabetes mellitus.
Resveratrol is a naturally occurring polyphenolic compound . Numerous animal studies have been reported on its wide-ranging beneficial effects in the biological system including diabetes mellitus ( DM ) . We hypothesized , therefore , that oral supplementation of resveratrol would improve the glycemic control and the associated risk factors in patients with type 2 diabetes mellitus ( T2DM ) . The present clinical study was therefore carried out to test the hypothesis . Sixty-two patients with T2DM were enrolled from Government Headquarters Hospital , Ootacamund , India , in a prospect i ve , open-label , r and omized , controlled trial . Patients were r and omized into control and intervention groups . The control group received only oral hypoglycemic agents , whereas the intervention group received resveratrol ( 250 mg/d ) along with their oral hypoglycemic agents for a period of 3 months . Hemoglobin A(1c ) , lipid profile , urea nitrogen , creatinine , and protein were measured at the baseline and at the end of 3 months . The results reveal that supplementation of resveratrol for 3 months significantly improves the mean hemoglobin A(1c ) ( means ± SD , 9.99 ± 1.50 vs 9.65 ± 1.54 ; P < .05 ) , systolic blood pressure ( mean ± SD , 139.71 ± 16.10 vs 127.92 ± 15.37 ; P < .05 ) , total cholesterol ( mean ± SD , 4.70 ± 0.90 vs 4.33 ± 0.76 ; P < .05 ) , and total protein ( mean ± SD , 75.6 ± 4.6 vs 72.3 ± 6.2 ; P < .05 ) in T2DM . No significant changes in body weight and high-density lipoprotein and low-density lipoprotein cholesterols were observed . Oral supplementation of resveratrol is thus found to be effective in improving glycemic control and may possibly provide a potential adjuvant for the treatment and management of diabetes
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
618
28,701,674
Resveratrol Ameliorates Arterial Stiffness Assessed by Cardio-Ankle Vascular Index in Patients With Type 2 Diabetes Mellitus.
Resveratrol has been reported to have potent anti-atherosclerotic effects in animal studies . However , there are few interventional studies in human patients with atherosclerogenic diseases . The cardio-ankle vascular index ( CAVI ) reflects arterial stiffness and is a clinical surrogate marker of atherosclerosis . The aim of the present study was to investigate the effect of resveratrol on arterial stiffness assessed by CAVI in patients with type 2 diabetes mellitus (T2DM).In this double-blind , r and omized , placebo-controlled study , 50 patients with T2DM received supplement of a 100 mg resveratrol tablet ( total resveratrol : oligo-stilbene 27.97 mg/100 mg/day ) or placebo daily for 12 weeks . CAVI was assessed at baseline and the end of study . Body weight ( BW ) , blood pressure ( BP ) , glucose and lipid metabolic parameters , and diacron-reactive oxygen metabolites ( d-ROMs ; an oxidative stress marker ) were also measured . Resveratrol supplementation decreased systolic BP ( -5.5 ± 13.0 mmHg ) , d-ROMs ( -25.6 ± 41.8 U.CARR ) , and CAVI ( -0.4 ± 0.7 ) significantly ( P < 0.05 ) and decreased BW ( -0.8 ± 2.1 kg , P = 0.083 ) and body mass index ( -0.5 ± 0.8 kg/m2 , P = 0.092 ) slightly compared to baseline , while there were no significant changes in the placebo group . Decreases in CAVI and d-ROMs were significantly greater in the resveratrol group than in the placebo group . Multivariate logistic regression analysis identified resveratrol supplementation as an independent predictor for a CAVI decrease of more than 0.5.In conclusion , 12-week resveratrol supplementation may improve arterial stiffness and reduce oxidative stress in patients with T2DM . Resveratrol may be beneficial in preventing the development of atherosclerosis induced by diabetes . However , a large-scale cohort study is required to vali date the present findings
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
619
3,555,235
Grape Resveratrol Increases Serum Adiponectin and Downregulates Inflammatory Genes in Peripheral Blood Mononuclear Cells: A Triple-Blind, Placebo-Controlled, One-Year Clinical Trial in Patients with Stable Coronary Artery Disease
Purpose The grape and wine polyphenol resveratrol exerts cardiovascular benefits but evidence from r and omized human clinical trials is very limited . We investigated dose-depending effects of a resveratrol-containing grape supplement on stable patients with coronary artery disease ( CAD ) treated according to currently accepted guidelines for secondary prevention of cardiovascular disease . Methods In a triple-blind , r and omized , placebo-controlled , one-year follow-up , 3-arm pilot clinical trial , 75 stable-CAD patients received 350 mg/day of placebo , resveratrol-containing grape extract ( grape phenolics plus 8 mg resveratrol ) or conventional grape extract lacking resveratrol during 6 months , and a double dose for the following 6 months . Changes in circulating inflammatory and fibrinolytic biomarkers were analyzed . Moreover , the transcriptional profiling of inflammatory genes in peripheral blood mononuclear cells ( P BMC s ) was explored using microarrays and functional gene expression analysis . Results After 1 year , in contrast to the placebo and conventional grape extract groups , the resveratrol-containing grape extract group showed an increase of the anti-inflammatory serum adiponectin ( 9.6 % , p = 0.01 ) and a decrease of the thrombogenic plasminogen activator inhibitor type 1 ( PAI-1 ) ( −18.6 % , p = 0.05 ) . In addition , 6 key inflammation-related transcription factors were predicted to be significantly activated or inhibited , with 27 extracellular-space acting genes involved in inflammation , cell migration and T-cell interaction signals presenting downregulation ( p < 0.05 ) in P BMC s. No adverse effects were detected in relation to the study products . Conclusions Chronic daily consumption of a resveratrol-containing grape nutraceutical could exert cardiovascular benefits in stable-CAD patients treated according to current evidence -based st and ards , by increasing serum adiponectin , preventing PAI-1 increase and inhibiting atherothrombotic signals in P BMC
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
620
3,773,903
Antihyperglycemic Effects of Short Term Resveratrol Supplementation in Type 2 Diabetic Patients
The objective of this study was to examine the effectiveness of resveratrol in lowering blood glucose in the presence of st and ard antidiabetic treatment in patients with type 2 diabetes , in a r and omized placebo-controlled double-blinded parallel clinical trial . A total of 66 subjects with type 2 diabetes were enrolled in this study and r and omly assigned to intervention group which was supplemented with resveratrol at a dose 1 g/day for 45 days and control group which received placebo tablets . Body weight , blood pressure , fasting blood glucose , haemoglobin A1c , insulin , homeostatic assessment s for insulin resistance , triglycerides , total cholesterol , low density lipoprotein , high density lipoprotein , and markers of liver and kidney damage were measured at baseline and after 45 days of resveratrol or placebo supplementation . Resveratrol treatment significantly decreased systolic blood pressure , fasting blood glucose , haemoglobin A1c , insulin , and insulin resistance , while HDL was significantly increased , when compared to their baseline levels . On the other h and , the placebo group had slightly increased fasting glucose and LDL when compared to their baseline levels . Liver and kidney function markers were unchanged in the intervention group . Overall , this study showed that resveratrol supplementation exerted strong antidiabetic effects in patients with type 2 diabetes
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
621
25,322,274
Resveratrol increases bone mineral density and bone alkaline phosphatase in obese men: a randomized placebo-controlled trial.
CONTEXT Metabolic syndrome ( MetS ) is associated with low- grade inflammation , which may harmfully affect bone . Resveratrol ( RSV ) possesses anti-inflammatory properties , and rodent studies suggest bone protective effects . OBJECTIVE This study sought to evaluate effects of RSV treatment on bone in men with MetS. SETTING AND DESIGN The study was conducted at Aarhus University Hospital as a r and omized , double-blinded , placebo-controlled trial assessing changes in bone turnover markers , bone mineral density ( BMD ) , and geometry . PARTICIPANTS The study population comprised 74 middle-aged obese men with MetS recruited from the general community , of which 66 completed all visits . Mean age of participants was 49.3 ± 6.3 years and mean body mass index was 33.7 ± 3.6 kg/m(2 ) . INTERVENTION Oral treatment with 1.000 mg RSV ( RSV(high ) ) , 150 mg RSV ( RSV(low ) ) , or placebo daily for 16 weeks . MAIN OUTCOME MEASURE Prespecified primary endpoint was change in bone alkaline phosphatase ( BAP ) . RESULTS BAP increased dose dependently with RSV ( R = 0.471 , P < .001 ) , result ing in a significantly greater increase in BAP in the RSV(high ) group compared with placebo at all time-points ( week 4 , 16.4 ± 4.2 % , P < .001 ; week 8 , 16.5 ± 4.1 % , P < .001 ; week 16 , 15.2 ± 3.7 % , P < .001 ) . Lumbar spine trabecular volumetric bone mineral density ( LS vBMD(trab ) ) also increased dose dependently with RSV ( R = 0.268 , P = .036 ) , with a significant increase of 2.6 ± 1.3 % in the RSV(high ) group compared with placebo ( P = .043 ) . In addition , changes in BAP and LS vBMD(trab ) were positively correlated ( R = 0.281 , P = .027 ) . No consistent changes were detected in bone density at the hip . CONCLUSIONS Our data suggest that high-dose RSV supplementation positively affects bone , primarily by stimulating formation or mineralization . Future studies of longer duration comprising population s at risk of osteoporosis are needed to confirm these results
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
622
27,852,684
Resveratrol as Add-on Therapy in Subjects With Well-Controlled Type 2 Diabetes: A Randomized Controlled Trial
OBJECTIVE To determine whether resveratrol supplementation can improve insulin sensitivity and promote overall metabolic health on top of st and ard diabetes care . RESEARCH DESIGN AND METHODS Seventeen subjects with well-controlled type 2 diabetes ( T2D ) were treated with placebo and 150 mg/day resveratrol ( resVida ) in a r and omized double-blind crossover study for 30 days . The main outcome measure was insulin sensitivity by the hyperinsulinemic-euglycemic clamp technique . RESULTS Hepatic and peripheral insulin sensitivity were not affected by resveratrol treatment . Intrahepatic lipid content also remained unaffected by resveratrol ; however , the change in intrahepatic lipid content correlated negatively with plasma resveratrol levels ( R = −0.68 , P = 0.03 ) . Intramyocellular lipid content increased in type 2 muscle fibers ( P = 0.03 ) , and systolic blood pressure tended to decrease ( P = 0.09 ) upon resveratrol treatment . In addition , resveratrol significantly improved ex vivo mitochondrial function ( state 3 and state U respiration upon malate with octanoyl-carnitine , P < 0.005 ) . Intriguingly , a correlation was found between plasma levels of a metabolite of resveratrol ( dihydroresveratrol ) and the metformin dose used by the patients ( R = 0.66 , P = 0.005 ) , suggesting an interaction between metformin and resveratrol . It could be speculated that the lack of a resveratrol-induced insulin-sensitizing effect is caused by this interaction . CONCLUSIONS Resveratrol supplementation does not improve hepatic or peripheral insulin sensitivity . Our results question the generalized value of resveratrol as an add-on therapy in the treatment of T2D and emphasize the need to perform studies in drug-naive patients with T2D or subjects with prediabetes
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
623
26,234,526
The effects of resveratrol supplementation on cardiovascular risk factors in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled study.
Non-alcoholic fatty liver disease ( NAFLD ) is usually associated with insulin resistance , central obesity , reduced glucose tolerance , type 2 diabetes mellitus and hypertriacylglycerolaemia . The beneficial effects of resveratrol on metabolic disorders have been shown previously . The aim of this study was to evaluate the effects of resveratrol supplementation on cardiovascular risk factors in patients with NAFLD . In this r and omised double-blinded placebo-controlled clinical trial , fifty NAFLD patients were supplemented with either a 500-mg resveratrol capsule or a placebo capsule for 12 weeks . Both groups were advised to follow an energy-balanced diet and physical activity recommendations . resveratrol supplementation reduced alanine aminotransferase ( ALT ) and hepatic steatosis significantly more than placebo ( P0·05 ) . There were no significant changes in blood pressure , insulin resistance markers and TAG in either group ( P>0·05 ) . Our data have shown that 12-week supplementation of 500 mg resveratrol does not have any beneficial effect on anthropometric measurements , insulin resistance markers , lipid profile and blood pressure ; however , it reduced ALT and hepatic steatosis in patients with NAFLD
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
624
24,582,567
Resveratrol does not benefit patients with nonalcoholic fatty liver disease.
BACKGROUND & AIMS Nonalcoholic fatty liver disease ( NAFLD ) , characterized by accumulation of hepatic triglycerides ( steatosis ) , is associated with abdominal obesity , insulin resistance , and inflammation . Although weight loss via calorie restriction reduces features of NAFLD , there is no pharmacologic therapy . Resveratrol is a polyphenol that prevents high-energy diet-induced steatosis and insulin resistance in animals by up-regulating pathways that regulate energy metabolism . We performed a placebo-controlled trial to assess the effects of resveratrol in patients with NAFLD . METHODS Overweight or obese men diagnosed with NAFLD were recruited from hepatology outpatient clinics in Brisbane , Australia from 2011 through 2012 . They were r and omly assigned to groups given 3000 mg resveratrol ( n = 10 ) or placebo ( n = 10 ) daily for 8 weeks . Outcomes included insulin resistance ( assessed by the euglycemic-hyperinsulinemic clamp ) , hepatic steatosis , and abdominal fat distribution ( assessed by magnetic resonance spectroscopy and imaging ) . Plasma markers of inflammation , as well as metabolic , hepatic , and antioxidant function , were measured ; transcription of target genes was measured in peripheral blood mononuclear cells . Resveratrol pharmacokinetics and safety were assessed . RESULTS Eight-week administration of resveratrol did not reduce insulin resistance , steatosis , or abdominal fat distribution when compared with baseline . No change was observed in plasma lipids or antioxidant activity . Levels of alanine and aspartate aminotransferases increased significantly among patients in the resveratrol group until week 6 when compared with the placebo group . Resveratrol did not significantly alter transcription of NQO1 , PTP1B , IL6 , or HO1 in peripheral blood mononuclear cells . Resveratrol was well-tolerated . CONCLUSIONS Eight weeks administration of resveratrol did not significantly improve any features of NAFLD , compared with placebo , but it increased hepatic stress , based on observed increases in levels of liver enzymes . Further studies are needed to determine whether agents that are purported to mimic calorie restriction , such as resveratrol , are safe and effective for complications of obesity . Clinical trials registration no : ACTRN12612001135808
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
34
29,359,958
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
625
23,743,811
Chronic resveratrol consumption improves brachial flow-mediated dilatation in healthy obese adults
Background : We have previously demonstrated acute dose-dependent increases of flow-mediated dilatation ( FMD ) in the brachial artery after resveratrol consumption in mildly hypertensive , overweight/obese adults . Resveratrol supplementation has also been shown to increase cerebral blood flow acutely , without affecting cognition . Objectives : To evaluate the effects of chronic resveratrol supplementation on both FMD and cognitive performance . Method : Twenty-eight obese but otherwise healthy adults ( BMI : 33.3 ± 0.6 kg/m2 ) were r and omized to take a single 75 mg capsule of trans-resveratrol ( Resvida ) or placebo daily for 6 weeks each in a double-blind crossover supplementation trial . Blood pressure , arterial compliance , FMD , and performance on the Stroop Color-Word Test were assessed at the end of each 6-week intervention period while fasted and at least 18 h after taking the last daily capsule . An additional capsule of the same supplement was then taken . FMD assessment was repeated 1 h later . Results : Chronic resveratrol supplementation for 6 weeks was well tolerated and result ed in a 23 % increase in FMD compared with placebo ( P = 0.021 , paired t-test ) . The extent of increase correlated negatively with baseline FMD ( r = −0.47 , P = 0.01 ) . A single dose of resveratrol ( 75 mg ) following chronic resveratrol supplementation result ed in a 35 % greater acute FMD response than the equivalent placebo supplementation . These FMD improvements remained significant after adjusting for baseline FMD . Blood pressure , arterial compliance , and all components of the Stroop Color-Word Test were unaffected by chronic resveratrol supplementation . Conclusion : Daily resveratrol consumption was well tolerated and has the potential to maintain healthy circulatory function in obese adults
34
Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients
ABSTRACT Introduction : Results of previous clinical trials evaluating the effect of resveratrol supplementation on blood pressure ( BP ) are controversial . Purpose : We aim ed to assess the impact of resveratrol on BP through systematic review of literature and meta- analysis of available r and omized , controlled clinical trials ( RCTs ) .
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
626
25,552,576
Exercise for falls prevention in Parkinson disease
Objective : To determine whether falls can be prevented with minimally supervised exercise targeting potentially remediable fall risk factors , i.e. , poor balance , reduced leg muscle strength , and freezing of gait , in people with Parkinson disease . Methods : Two hundred thirty-one people with Parkinson disease were r and omized into exercise or usual-care control groups . Exercises were practice d for 40 to 60 minutes , 3 times weekly for 6 months . Primary outcomes were fall rates and proportion of fallers during the intervention period . Secondary outcomes were physical ( balance , mobility , freezing of gait , habitual physical activity ) , psychological ( fear of falling , affect ) , and quality -of-life measures . Results : There was no significant difference between groups in the rate of falls ( incidence rate ratio [ IRR ] = 0.73 , 95 % confidence interval [ CI ] 0.45–1.17 , p = 0.18 ) or proportion of fallers ( p = 0.45 ) . Preplanned subgroup analysis revealed a significant interaction for disease severity ( p < 0.001 ) . In the lower disease severity subgroup , there were fewer falls in the exercise group compared with controls ( IRR = 0.31 , 95 % CI 0.15–0.62 , p < 0.001 ) , while in the higher disease severity subgroup , there was a trend toward more falls in the exercise group ( IRR = 1.61 , 95 % CI 0.86–3.03 , p = 0.13 ) . Postintervention , the exercise group scored significantly ( p < 0.05 ) better than controls on the Short Physical Performance Battery , sit-to-st and , fear of falling , affect , and quality of life , after adjusting for baseline performance . Conclusions : An exercise program targeting balance , leg strength , and freezing of gait did not reduce falls but improved physical and psychological health . Falls were reduced in people with milder disease but not in those with more severe Parkinson disease . Classification of evidence : This study provides Class III evidence that for patients with Parkinson disease , a minimally supervised exercise program does not reduce fall risk . This study lacked the precision to exclude a moderate reduction or modest increase in fall risk from exercise . Trial registration : Australian New Zeal and Clinical Trials Registry ( ACTRN12608000303347 )
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
627
3,199,203
The PIT: SToPP Trial—A Feasibility Randomised Controlled Trial of Home-Based Physiotherapy for People with Parkinson's Disease Using Video-Based Measures to Preserve Assessor Blinding
Purpose . To trial four-week 's physiotherapy targeting chair transfers for people with Parkinson 's disease ( PwPD ) and explore the feasibility of reliance on remote outcome measurement to preserve blinding . Scope . We recruited 47 PwPD and r and omised 24 to a focused home physiotherapy programme ( exercise , movement strategies , and cueing ) and 23 to a control group . We evaluated transfers ( plus mobility , balance , posture , and quality of life ) before and after treatment and at followup ( weeks 0 , 4 , 8 , and 12 ) from video produced by , and question naires distributed by , treating physiotherapists . Participants fed back via end-of- study question naires . Thirty-five participants ( 74 % ) completed the trial . Excluding dropouts , 20 % of question naire data and 9 % of video data were missing or unusable ; we had to evaluate balance in situ . We noted trends to improvement in transfers , mobility , and balance in the physiotherapy group not noted in the control group . Participant feedback was largely positive and assessor blinding was maintained in every case . Conclusions . Intense , focused physiotherapy at home appears acceptable and likely to bring positive change in those who can participate . Remote outcome measurement was successful ; question naire followup and further training in video production would reduce missing data . We advocate a fully powered trial , design ed to minimise dropouts and preserve assessor blinding , to evaluate this intervention
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
628
28,745,063
Home-based step training using videogame technology in people with Parkinson’s disease: a single-blinded randomised controlled trial
Objectives : To determine whether 12-week home-based exergame step training can improve stepping performance , gait and complementary physical and neuropsychological measures associated with falls in Parkinson ’s disease . Design : A single-blinded r and omised controlled trial . Setting : Community ( experimental intervention ) , university laboratory ( outcome measures ) . Subjects : Sixty community-dwelling people with Parkinson ’s disease . Interventions : Home-based step training using videogame technology . Main measures : The primary outcomes were the choice stepping reaction time test and Functional Gait Assessment . Secondary outcomes included physical and neuropsychological measures associated with falls in Parkinson ’s disease , number of falls over six months and self-reported mobility and balance . Results : Post intervention , there were no differences between the intervention ( n = 28 ) and control ( n = 25 ) groups in the primary or secondary outcomes except for the Timed Up and Go test , where there was a significant difference in favour of the control group ( P = 0.02 ) . Intervention participants reported mobility improvement , whereas control participants reported mobility deterioration — between-group difference on an 11-point scale = 0.9 ( 95 % confidence interval : −1.8 to −0.1 , P = 0.03 ) . Interaction effects between intervention and disease severity on physical function measures were observed ( P = 0.01 to P = 0.08 ) with seemingly positive effects for the low-severity group and potentially negative effects for the high-severity group . Conclusion : Overall , home-based exergame step training was not effective in improving the outcomes assessed . However , the improved physical function in the lower disease severity intervention participants as well as the self-reported improved mobility in the intervention group suggest home-based exergame step training may have benefits for some people with Parkinson ’s disease
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
629
28,445,854
Balance training in individuals with Parkinson's disease: Therapist-supervised vs. home-based exercise programme.
BACKGROUND Poor locomotion and balance in Parkinson 's disease ( PD ) often diminishes independence . Accordingly , gait is considered one of the most relevant rehabilitation outcomes , and home-based balance exercises might be a viable mode of exercise delivery for individuals with PD . However , research on PD interventions rarely indicate best practice s to deliver exercises . Therefore , this study endeavoured to compare the efficacy of a home-based and therapist-supervised balance programme on gait parameters , dynamic balance , balance confidence and motivation in individuals diagnosed with PD . METHODS An experimental study design , including a cluster r and omized convenience sample , of 40 participants with idiopathic PD ( Hoehn and Yahr stage I-III ; age : 65.0±7.7years ) . Participants were divided into a therapist-supervised ( n=24 ) and home-based group ( n=16 ) . Groups received either eight weeks of balance training with an exercise therapist or a DVD . Outcome measures include the instrumented Timed-Up- and -Go , Functional Gait Analysis ( FGA ) , Activity-specific Balance confidence ( ABC ) scale and Intrinsic Motivation Inventory ( IMI ) . RESULTS Both groups improved in stride length ( p<0.05 ) . Similar FGA improved by 9 % and 16 % in the therapist-supervised and home-based group , respectively ( p<0.01 ) . Only the therapist-supervised group showed improvements in ABC ( p=0.051 ) , stride velocity ( p=0.0006 ) and cadence ( p=0.046 ) over the intervention ; the latter two were also better compared to home-based ( p<0.05 ) . Furthermore the therapist-supervised group were more motivated ( p=002 ) . CONCLUSION The home-based balance programme was effective in improving some aspects of gait , albeit the programme supervised by an exercise therapist included somewhat more benefits after the intervention i.e. stride velocity and cadence in individuals with mild to moderate PD
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
630
28,342,682
A home program of strength training, movement strategy training and education did not prevent falls in people with Parkinson's disease: a randomised trial.
QUESTIONS For people with idiopathic Parkinson 's disease , does a 6-week , comprehensive , home exercise program reduce falls and disability and improve health-related quality of life ? Is the program cost-effective ? DESIGN R and omised , controlled trial with concealed allocation and assessor blinding . PARTICIPANTS One hundred and thirty-three community-dwelling adults with Parkinson 's disease . INTERVENTION The experimental group completed a 6-week home program comprising progressive resistance strength training , movement strategy training and falls education . The control group completed 6 weeks of non-specific life skills training . Participants in both groups received weekly therapist-guided sessions for 6 consecutive weeks and a weekly self-directed home program . OUTCOME MEASURES The primary outcome was the rate of falls , documented for the 12-month period immediately after therapy . Secondary outcomes were disability and health-related quality of life , assessed before and after intervention and at a 12-month follow-up . RESULTS A total of 2255 falls were reported by the 12-month follow-up . The proportion of fallers in the experimental and control groups was 61 and 72 % , respectively , which was not statistically significantly different ( RR=0.85 , 95 % CI 0.66 to 1.09 ) . There was no significant between-group difference in the rate of falls ( incidence rate ratio=1.58 , 95 % CI 0.73 to 3.43 ) . A survival analysis of participant time to first fall did not show a significant between-group difference ( log-rank test χ2=0.79 , p=0.37 ) . No significant between-group differences occurred for mobility , disability or quality of life . The mean cost of delivering the experimental intervention was AUD1596 . CONCLUSION A home program of strength and movement strategy training and falls education does not prevent falls when applied at the dose used in this study . Arguably , the dosage of therapy was insufficient . Future trials need to explore further therapy content , repetitions and duration , in order to optimise outcomes and cost-effectiveness . [ Morris ME , Taylor NF , Watts JJ , Evans A , Horne M , Kempster P , Danoudis M , McGinley J , Martin C , Menz HB ( 2017 ) A home program of strength training , movement strategy training and education did not prevent falls in people with Parkinson 's disease : a r and omised trial . Journal of Physiotherapy 63 : 94 - 100 ]
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
631
5,733,154
Virtual Reality Telerehabilitation for Postural Instability in Parkinson's Disease: A Multicenter, Single-Blind, Randomized, Controlled Trial
Introduction Telerehabilitation enables patients to access remote rehabilitation services for patient-physiotherapist videoconferencing in their own homes . Home-based virtual reality ( VR ) balance training has been shown to reduce postural instability in patients with Parkinson 's disease ( PD ) . The primary aim was to compare improvements in postural stability after remotely supervised in-home VR balance training and in-clinic sensory integration balance training ( SIBT ) . Methods In this multicenter study , 76 PD patients ( modified Hoehn and Yahr stages 2.5–3 ) were r and omly assigned to receive either in-home VR telerehabilitation ( n = 38 ) or in-clinic SIBT ( n = 38 ) in 21 sessions of 50 minutes each , 3 days/week for 7 consecutive weeks . VR telerehabilitation consisted of grade d exergames using the Nintendo Wii Fit system ; SIBT included exercises to improve postural stability . Patients were evaluated before treatment , after treatment , and at 1-month follow-up . Results Analysis revealed significant between-group differences in improvement on the Berg Balance Scale for the VR telerehabilitation group ( p = 0.04 ) and significant Time × Group interactions in the Dynamic Gait Index ( p = 0.04 ) for the in-clinic group . Both groups showed differences in all outcome measures over time , except for fall frequency . Cost comparison yielded between-group differences in treatment and equipment costs . Conclusions VR is a feasible alternative to in-clinic SIBT for reducing postural instability in PD patients having a caregiver
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
632
22,257,506
Home-based treadmill training for individuals with Parkinson’s disease: a randomized controlled pilot trial
Objective : To investigate the feasibility and effectiveness of six weeks of home-based treadmill training in people with mild Parkinson ’s disease . Design : Pilot r and omized controlled trial of a six-week intervention followed by a further six weeks follow-up . Setting : Home-based treadmill training with outcome measures taken at a hospital clinic . Participants : Twenty cognitively intact participants with mild Parkinson ’s disease and gait disturbance . Two participants from the treadmill training group and one from the control group dropped out . Interventions : The treadmill training group undertook a semi-supervised home-based programme of treadmill walking for 20–40 minutes , four times a week for six weeks . The control group received usual care . Main outcome measures : The feasibility of the intervention was assessed by recording exercise adherence and acceptability , exercise intensity , fatigue , muscle soreness and adverse events . The primary outcome measure of efficacy was walking capacity ( 6-minute walk test distance ) . Results : Home-based treadmill training was feasible , acceptable and safe with participants completing 78 % ( SD 36 ) of the prescribed training sessions . The treadmill training group did not improve their walking capacity compared to the control group . The treadmill training group showed a greater improvement than the control group in fatigue at post test ( P = 0.04 ) and in quality of life at six weeks follow-up testing ( P = 0.02 ) . Conclusions : Semi-supervised home-based treadmill training is a feasible and safe form of exercise for cognitively intact people with mild Parkinson ’s disease . Further investigation regarding the effectiveness of home-based treadmill training is warranted
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
633
20,947,672
Minimal Detectable Change of the Timed “Up & Go” Test and the Dynamic Gait Index in People With Parkinson Disease
Background The minimal detectable change ( MDC ) is the smallest amount of difference in individual scores that represents true change ( beyond r and om measurement error ) . The MDCs of the Timed “ Up & Go ” Test ( TUG ) and the Dynamic Gait Index ( DGI ) in people with Parkinson disease ( PD ) are largely unknown , limiting the interpretability of the change scores of both measures . Objective The purpose of this study was to estimate the MDCs of the TUG and the DGI in people with PD . Design This investigation was a prospect i ve cohort study . Methods Seventy-two participants were recruited from special clinics for movement disorders at a university hospital . Their mean age was 67.5 years , and 61 % were men . All participants completed the TUG and the DGI assessment s twice , about 14 days apart . The MDC was calculated from the st and ard error of measurement . The percentage MDC ( MDC% ) was calculated as the MDC divided by the mean of all scores for the sample . Furthermore , the intraclass correlation coefficient was used to examine the reproducibility between testing sessions ( test-retest reliability ) . Results The respective MDC and MDC% of the TUG were 3.5 seconds and 29.8 , and those of the DGI were 2.9 points and 13.3 . The test-retest reliability values for the TUG and the DGI were high ; the intraclass correlation coefficients were .80 and .84 , respectively . Limitations The study sample was a convenience sample , and the participants had mild to moderately severe PD . Conclusions The results showed that the TUG and the DGI have generally acceptable r and om measurement error and test-retest reliability . These findings should help clinicians and research ers determine whether a change in an individual patient with PD is a true change
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
634
20,360,152
Comparison of the effects of a physiotherapist-supervised exercise programme and a self-supervised exercise programme on quality of life in patients with Parkinson’s disease
Objectives : To compare the effects of a physiotherapist-supervised exercise programme in an exercise unit and self-supervised home exercise programme on quality of life in patients with Parkinson ’s disease . Design : Assessor-blinded , quasi-r and omized trial ( alternate allocation ) . Setting : An outpatient exercise unit ; home setting s. Participants : Thirty patients with idiopathic Parkinson ’s disease , Hoehn & Yahr I — III , stable medication use . Interventions : Patients were included in the physiotherapist-supervised or home group . The exercise programme was performed for 10 weeks , three times/week either under the supervision of a physiotherapist or at home without supervision . Main outcome measures : Parkinson ’s Disease Quality of Life Question naire ( PDQLQ ) , Nottingham Health Profile ( NHP ) , Unified Parkinson ’s Disease Rating Scale ( UPDRS ) , Beck Depression Inventory ( BDI ) . Results : Patients in the supervised physiotherapy group improved more than the home exercise group in Parkinson ’s Disease Quality of Life Question naire ( total score , Parkinson ’s symptoms , emotional function ) , Nottingham Health Profile total , Unified Parkinson ’s Disease Rating Scale ( all domains ) and Beck Depression Inventory scores . Conclusions : The exercise programme under physiotherapist supervision was found to be more effective at improving activities of daily living , motor , mental , emotional functions and general health quality in patients with Parkinson ’s disease compared with a self-supervised home programme
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
635
3,560,229
An exercise intervention to prevent falls in Parkinson’s: an economic evaluation
Background People with Parkinson ’s ( PwP ) experience frequent and recurrent falls . As these falls may have devastating consequences , there is an urgent need to identify cost-effective interventions with the potential to reduce falls in PwP. The purpose of this economic evaluation is to compare the costs and cost-effectiveness of a targeted exercise programme versus usual care for PwP who were at risk of falling . Methods One hundred and thirty participants were recruited through specialist clinics , primary care and Parkinson ’s support groups and r and omised to either an exercise intervention or usual care . Health and social care utilisation and health-related quality of life ( EQ-5D ) were assessed over the 20 weeks of the study ( ten-week intervention period and ten-week follow up period ) , and these data were complete for 93 participants . Incremental cost per quality adjusted life year ( QALY ) was estimated . The uncertainty around costs and QALYs was represented using cost-effectiveness acceptability curves . Results The mean cost of the intervention was £ 76 per participant . Although in direction of favour of exercise intervention , there was no statistically significant differences between groups in total healthcare ( −£128 , 95 % CI : -734 to 478 ) , combined health and social care costs ( £ -35 , 95 % CI : -817 to 746 ) or QALYs ( 0.03 , 95 % CI : -0.02 to 0.03 ) at 20 weeks . Nevertheless , exploration of the uncertainty surrounding these estimates suggests there is more than 80 % probability that the exercise intervention is a cost-effective strategy relative to usual care . Conclusion Whilst we found no difference between groups in total healthcare , total social care cost and QALYs , analyses indicate that there is high probability that the exercise intervention is cost-effective compared with usual care . These results require confirmation by larger trial-based economic evaluations and over the longer term
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
636
20,629,134
The effects of an exercise program on fall risk factors in people with Parkinson's disease: a randomized controlled trial.
This r and omized controlled trial with blinded assessment aim ed to determine the effect of a 6-month minimally supervised exercise program on fall risk factors in people with Parkinson 's disease ( PD ) . Forty-eight participants with PD who had fallen or were at risk of falling were r and omized into exercise or control groups . The exercise group attended a monthly exercise class and exercised at home three times weekly . The intervention targeted leg muscle strength , balance , and freezing . The primary outcome measure was a PD falls risk score . The exercise group had no major adverse events and showed a greater improvement than the control group in the falls risk score , which was not statistically significant ( between group mean difference = -7 % , 95 % CI -20 to 5 , P = 0.26 ) . There were statistically significant improvements in the exercise group compared with the control group for two secondary outcomes : Freezing of Gait Question naire ( P = 0.03 ) and timed sit-to-st and ( P = 0.03 ) . There were statistically nonsignificant trends toward greater improvements in the exercise group for measures of muscle strength , walking , and fear of falling , but not for the measures of st and ing balance . Further investigation of the impact of exercise on falls in people with PD is warranted
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
637
3,236,465
Exercise and Motor Training in People with Parkinson's Disease: A Systematic Review of Participant Characteristics, Intervention Delivery, Retention Rates, Adherence, and Adverse Events in Clinical Trials
There is research evidence that exercise and motor training are beneficial for people with Parkinson 's disease ( PD ) , and clinicians seek to implement optimal programs . This paper summarizes important factors about the nature and reporting of r and omized controlled trials of exercise and /or motor training for people with PD which are likely to influence the translation of research into clinical practice . Search es identified 53 relevant trials with 90 interventions conducted for an average duration of 8.3 ( SD 4.2 ) weeks . Most interventions were fully supervised ( 74 % ) and conducted at a facility ( 79 % ) . Retention rates were high with 69 % of interventions retaining ≥85 % of their participants ; however adherence was infrequently reported , and 72 % of trials did not report adverse events . Overall , the labor-intensive nature of most interventions tested in these trials and the sparse reporting of adherence and adverse events are likely to pose difficulties for therapists attempting to balance benefits and costs when selecting protocol s that translate to sustainable clinical practice for people with PD
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
638
4,582,836
The Effects of Highly Challenging Balance Training in Elderly With Parkinson’s Disease
Background . Highly challenging exercises have been suggested to induce neuroplasticity in individuals with Parkinson ’s disease ( PD ) ; however , its effect on clinical outcomes remains largely unknown . Objective . To evaluate the short-term effects of the HiBalance program , a highly challenging balance-training regimen that incorporates both dual-tasking and PD-specific balance components , compared with usual care in elderly with mild to moderate PD . Methods . Participants with PD ( n = 100 ) were r and omized , either to the 10-week HiBalance program ( n = 51 ) or to the control group ( n = 49 ) . Participants were evaluated before and after the intervention . The main outcomes were balance performance ( Mini-BESTest ) , gait velocity ( during normal and dual-task gait ) , and concerns about falling ( Falls Efficacy Scale – International ) . Performance of a cognitive task while walking , physical activity level ( average steps per day ) , and activities of daily living were secondary outcomes . Results . A total of 91 participants completed the study . After the intervention , the between group comparison showed significantly improved balance and gait performance in the training group . Moreover , although no significant between group difference was observed regarding gait performance during dual-tasking ; the participants in the training group improved their performance of the cognitive task while walking , as compared with the control group . Regarding physical activity levels and activities of daily living , in comparison to the control group , favorable results were found for the training group . No group differences were found for concerns about falling . Conclusions . The HiBalance program significantly benefited balance and gait abilities when compared with usual care and showed promising transfer effects to everyday living . Long-term follow-up assessment s will further explore these effects
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
639
16,323,386
Effects of home exercises on motor performance in patients with Parkinson's disease
Objective : To investigate the effect of home exercises on the motor performance of patients with Parkinson 's disease . Design : A prospect i ve blinded study with allocation of patients into their groups by alternate weeks . Setting : A University Hospital neurology and physiotherapy department . Subjects : Recruited from a movement disorders outpatient clinic of Cerrahpasa School of Medicine diagnosed with Parkinson 's disease , classified as Hoehn and Yahr Grade s I , II and III . Interventions : Patients who fulfilled the inclusion criteria were recruited to the study . Each patient was evaluated at the end of first and second month after the baseline evaluation . Patients were divided into two groups . Those in the first and third week were put in the exercise group and second and fourth week in the control group . Patients in the exercise group ( n=15 ) were given a schedule of exercises to undertake at home ; the others ( n=15 ) did not receive this instruction . Measures : Ten- and 20-m walking test , first pace length , pace number in 10 m , walking around a chair , Nine Hole Peg Board ( NHPB ) test . Results : Following the home exercise programme , patients in the exercise group showed improvement in walking 10 and 20 m , time elapsed to complete walking around a chair and length of the first pace length , and in the motor performance of both h and s ( p < 0.001 ) . Conclusions : A home-based rehabilitation programme for patients with Parkinson 's disease helped to improve motor performance compared to patients who did not take advantage of a regular , professionally design ed exercise programme
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
640
11,175,678
Reliability of measurements obtained with the Timed "Up & Go" test in people with Parkinson disease.
BACKGROUND AND PURPOSE The Timed " Up & Go " Test ( TUG ) is used to measure the ability of patients to perform sequential locomotor tasks that incorporate walking and turning . This study investigated the retest reliability , interrater reliability , and sensitivity of scores obtained with the TUG in detecting changes in mobility in subjects with idiopathic Parkinson disease ( PD ) . SUBJECTS The performance of 12 people with PD was compared with that of 12 age-matched comparison subjects without PD . METHODS The subjects with PD completed 5 trials of the TUG after withdrawal of levodopa for 12 hours ( " off " phase of the medication cycle ) as well as an additional 5 trials 1 hour after levodopa was administered ( " on " phase of the medication cycle ) . They were scored on the Modified Webster Scale at both sessions . The comparison subjects also performed 5 TUG trials . All trials were videotaped and timed by 2 experienced raters . The videotape was later rated by 3 experienced clinicians and 3 inexperienced clinicians . RESULTS For the subjects with PD , within-session performance was highly consistent , with correlations ( r ) ranging from.80 to.98 for the " off " phase and from.73 to.99 for the " on " phase . The performance of the comparison subjects across the 5 trials was also highly consistent ( r=.90-.97 ) . Comparisons showed differences between trials 1 and 2 on the TUG for both groups . Removal of data for trial 1 ( the practice trial ) further enhanced retest reliability . There was close agreement in TUG scores among raters despite different levels of experience ( intraclass correlation coefficient [3,1]=.87-.99 ) . Mean TUG scores were different between the " on " and " off " phases of the levodopa cycle and between subjects with PD and comparison subjects during the " on " phase . CONCLUSION AND DISCUSSION Retest reliability and interrater reliability of the TUG measurements were high , and the measurements reflected changes in performance according to levodopa use . The TUG can also be used to detect differences in performance between people with PD and elderly people without PD
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
641
23,023,812
Comparison of Reliability, Validity, and Responsiveness of the Mini-BESTest and Berg Balance Scale in Patients With Balance Disorders
Background Recently , a new tool for assessing dynamic balance impairments has been presented : the 14-item Mini-BESTest . Objective The aim of this study was to compare the psychometric performance of the Mini-BESTest and the Berg Balance Scale ( BBS ) . Design A prospect i ve , single-group , observational design was used in the study . Methods Ninety-three participants ( mean age=66.2 years , SD=13.2 ; 53 women , 40 men ) with balance deficits were recruited . Interrater ( 3 raters ) and test-retest ( 1–3 days ) reliability were calculated using intraclass correlation coefficients ( ICCs ) . Responsiveness and minimal important change were assessed ( after 10 sessions of physical therapy ) using both distribution-based and anchor-based methods ( external criterion : the 15-point Global Rating of Change [ GRC ] scale ) . Results At baseline , neither floor effects nor ceiling effects were found in either the Mini-BESTest or the BBS . After treatment , the maximum score was found in 12 participants ( 12.9 % ) with BBS and in 2 participants ( 2.1 % ) with Mini-BESTest . Test-retest reliability for total scores was significantly higher for the Mini-BESTest ( ICC=.96 ) than for the BBS ( ICC=.92 ) , whereas interrater reliability was similar ( ICC=.98 versus .97 , respectively ) . The st and ard error of measurement ( SEM ) was 1.26 and the minimum detectable change at the 95 % confidence level ( MDC95 ) was 3.5 points for Mini-BESTest , whereas the SEM was 2.18 and the MDC95 was 6.2 points for the BBS . In receiver operating characteristic curves , the area under the curve was 0.92 for the Mini-BESTest and 0.91 for the BBS . The best minimal important change ( MIC ) was 4 points for the Mini-BESTest and 7 points for the BBS . After treatment , 38 participants evaluated with the Mini-BESTest and only 23 participants evaluated with the BBS ( out of the 40 participants who had a GRC score of ≥3.5 ) showed a score change equal to or greater than the MIC values . Limitations The consecutive sampling method drawn from a single rehabilitation facility and the intrinsic weakness of the GRC for calculating MIC values were limitations of the study . Conclusions The 2 scales behave similarly , but the Mini-BESTest appears to have a lower ceiling effect , slightly higher reliability levels , and greater accuracy in classifying individual patients who show significant improvement in balance function
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
642
15,827,933
Validating the Berg Balance Scale for patients with Parkinson's disease: a key to rehabilitation evaluation.
OBJECTIVE To assess the criterion-related validity of the Berg Balance Scale ( BBS ) in subjects with Parkinson 's disease ( PD ) . DESIGN Prospect i ve , correlational analysis between the BBS and accepted measures of PD motor and functional impairment . SETTING The federally funded PD research center , an interdisciplinary center of excellence for people with PD within a Veterans Affairs medical center . PARTICIPANTS Thirty-eight men ( average + /- st and ard deviation , 71.1+/-10.5 y ) with confirmed PD . Their initial diagnosis had been made on average 5.8+/-3.6 years earlier . All could st and or walk unassisted and had mild to moderate disability . Patients who could not ambulate without assistive devices were excluded . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Correlational analyses between the BBS and the Unified Parkinson 's Disease Rating Scale ( UPDRS ) motor scale , Modified Hoehn and Yahr Staging ( Hoehn and Yahr ) Scale , and the Modified Schwab and Engl and Capacity for Daily Living Scale ( S&E ADL Scale ) . RESULTS BBS score showed significant correlations with indicators of motor functioning , stage of disease , and daily living capacity . BBS score was inversely associated with the UPDRS motor score ( -.58 , P < .005 ) , Hoehn and Yahr Scale staging ( -.45 , P < .005 ) , and S&E ADL Scale rating ( .55 , P < .005 ) . In all 3 correlations , lower scores on the BBS ( indicating greater balance deficits ) correlated with higher UPDRS scores ( indicating greater motoric or functional impairment ) . CONCLUSIONS Results support the criterion-related validity of the BBS . Its utility in other balance conditions of older adults has been established . Rehabilitation interventions have been shown to improve the balance deficits associated with PD . Early referral and periodic re assessment is vital to achieving and maintaining improvements . Our research results agree with other published research in suggesting that the BBS may be used as a screening tool and ongoing assessment tool for patients with PD
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
643
12,882,612
Reliability of the PEDro scale for rating quality of randomized controlled trials.
BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from " fair " to " substantial , " and the reliability of the total PEDro score was " fair " to " good .
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
644
17,119,004
A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson’s disease
Objective : To evaluate the effectiveness of a personalised home programme of exercises and strategies for repeat fallers with Parkinson ’s disease ( PD ) . Method : Patients with a confirmed diagnosis of idiopathic PD , independently mobile , living at home in the community , experiencing more than one fall in the previous 12 months and with intact gross cognitive function were invited to participate in this r and omised controlled trial . Usual care was compared with a personalised 6 week , home based exercise and strategy programme . The primary outcomes were rates of falling at 8 weeks and 6 months . Whether participants had repeat fallen , nearly fallen or experienced injurious falls were also examined . Functional Reach , the Berg Balance Test , PD Self- assessment Scale and the Euro Quol were rated by a blinded assessor . Results : Participants were r and omised to the exercise ( n = 70 ) and control ( n = 72 ) groups . There was a consistent trend towards lower fall rates in the exercise group at both 8 weeks and 6 months and lower rates of injurious falls needing medical attention at 6 months . Lower rates of repeat near falling were evident for the exercise group at 8 weeks ( p = 0.004 ) and 6 months ( p = 0.007 ) . There was a positive effect of exercises at 6 months on Functional Reach ( p = 0.009 ) and quality of life ( p = 0.033 ) . No significant differences were found on other secondary outcomes measures . Conclusion : There was a trend towards a reduction in fall events and injurious falls with a positive effect of exercises on near falls and quality of life
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
645
25,567,121
A Randomized Controlled Trial to Reduce Falls in People With Parkinson’s Disease
Background . Falls are common and disabling in people with Parkinson ’s disease ( PD ) . There is a need to quantify the effects of movement rehabilitation on falls in PD . Objective . To evaluate 2 physical therapy interventions in reducing falls in PD . Methods . We r and omized 210 people with PD to 3 groups : progressive resistance strength training coupled with falls prevention education , movement strategy training combined with falls prevention education , and life-skills information ( control ) . All received 8 weeks of out-patient therapy once per week and a structured home program . The primary end point was the falls rate , recorded prospect ively over a 12 month period , starting from the completion of the intervention . Secondary outcomes were walking speed , disability , and quality of life . Results . A total of 1547 falls were reported for the trial . The falls rate was higher in the control group compared with the groups that received strength training or strategy training . There were 193 falls for the progressive resistance strength training group , 441 for the movement strategy group and 913 for the control group . The strength training group had 84.9 % fewer falls than controls ( incidence rate ratio [ IRR ] = 0.151 , 95 % CI 0.071 - 0.322 , P < .001 ) . The movement strategy training group had 61.5 % fewer falls than controls ( IRR = 0.385 , 95 % CI 0.184 - 0.808 , P = .012 ) . Disability scores improved in the intervention groups following therapy while deteriorating in the control group . Conclusions . Rehabilitation combining falls prevention education with strength training or movement strategy training reduces the rate of falls in people with mild to moderately severe PD and is feasible
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
646
17,229,744
Cueing training in the home improves gait-related mobility in Parkinson’s disease: the RESCUE trial
Objectives : Gait and mobility problems are difficult to treat in people with Parkinson ’s disease . The Rehabilitation in Parkinson ’s Disease : Strategies for Cueing ( RESCUE ) trial investigated the effects of a home physiotherapy programme based on rhythmical cueing on gait and gait-related activity . Methods : A single-blind r and omised crossover trial was set up , including 153 patients with Parkinson ’s disease aged between 41 and 80 years and in Hoehn and Yahr stage II – IV . Subjects allocated to early intervention ( n = 76 ) received a 3-week home cueing programme using a prototype cueing device , followed by 3 weeks without training . Patients allocated to late intervention ( n = 77 ) underwent the same intervention and control period in reverse order . After the initial 6 weeks , both groups had a 6-week follow-up without training . Posture and gait scores ( PG scores ) measured at 3 , 6 and 12 weeks by blinded testers were the primary outcome measure . Secondary outcomes included specific measures on gait , freezing and balance , functional activities , quality of life and carer strain . Results : Small but significant improvements were found after intervention of 4.2 % on the PG scores ( p = 0.005 ) . Severity of freezing was reduced by 5.5 % in freezers only ( p = 0.007 ) . Gait speed ( p = 0.005 ) , step length ( p<0.001 ) and timed balance tests ( p = 0.003 ) improved in the full cohort . Other than a greater confidence to carry out functional activities ( Falls Efficacy Scale , p = 0.04 ) , no carry-over effects were observed in functional and quality of life domains . Effects of intervention had reduced considerably at 6-week follow-up . Conclusions : Cueing training in the home has specific effects on gait , freezing and balance . The decline in effectiveness of intervention effects underscores the need for permanent cueing devices and follow-up treatment . Cueing training may be a useful therapeutic adjunct to the overall management of gait disturbance in Parkinson ’s disease
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
647
26,308,937
Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial
Background and Purpose : Comparative studies of exercise interventions for people with Parkinson disease ( PD ) rarely considered how one should deliver the intervention . The objective of this study was to compare the success of exercise when administered by ( 1 ) home exercise program , ( 2 ) individualized physical therapy , or ( 3 ) a group class . We examined if common comorbidities associated with PD impacted success of each intervention . Methods : Fifty-eight people ( age = 63.9 ± 8 years ) with PD participated . People were r and omized into ( 1 ) home exercise program , ( 2 ) individual physical therapy , or ( 3 ) group class intervention . All arms were st and ardized and based on the Agility Boot Camp exercise program for PD , 3 times per week for 4 weeks . The primary outcome measure was the 7-item Physical Performance Test . Other measures of balance , gait , mobility , quality of life , balance confidence , depressions , apathy , self-efficacy and UPDRS-Motor , and activity of daily living scores were included . Results : Only the individual group significantly improved in the Physical Performance Test . The individual exercise showed the most improvements in functional and balance measures , whereas the group class showed the most improvements in gait . The home exercise program improved the least across all outcomes . Several factors effected success , particularly for the home group . Discussion and Conclusions : An unsupervised , home exercise program is the least effective way to deliver exercise to people with PD , and individual and group exercises have differing benefits . Furthermore , people with PD who also have other comorbidities did better in a program directly supervised by a physical therapist . Video Abstract available for additional insights from the authors ( see Video , Supplemental Digital Content 1 , http://links.lww.com/JNPT/A112 )
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
648
21,856,692
An exercise intervention to prevent falls in people with Parkinson's disease: a pragmatic randomised controlled trial
Objectives To compare the effectiveness of an exercise programme with usual care in people with Parkinson 's disease ( PD ) who have a history of falls . Design Pragmatic r and omised controlled trial . Setting Recruitment was from three primary and four secondary care organisations , and PD support groups in South West Engl and . The intervention was delivered in community setting s. Participants People with PD , with a history of two or more falls in the previous year , who were able to mobilise independently . Intervention 10 week , physiotherapy led , group delivered strength and balance training programme with supplementary home exercises ( intervention ) or usual care ( control ) . Main outcome measure Number of falls during the ( a ) 10 week intervention period and ( b ) the 10 week follow-up period . Results 130 people were recruited and r and omised ( 64 to the intervention ; 66 to usual care ) . Seven participants ( 5.4 % ) did not complete the study . The incidence rate ratio for falls was 0.68 ( 95 % CI 0.43 to 1.07 , p=0.10 ) during the intervention period and 0.74 ( 95 % CI 0.41 to 1.33 , p=0.31 ) during the follow-up period . Statistically significant between group differences were observed in Berg balance , Falls Efficacy Scale-International scores and recreational physical activity levels . Conclusions The study did not demonstrate a statistically significant between group difference in falls although the difference could be considered clinical ly significant . However , a type 2 error can not be ruled out . The findings from this trial add to the evidence base for physiotherapy and exercise in the management of people with PD . Trial registration IS RCT N50793425
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
649
28,097,926
A pilot study of a minimally supervised home exercise and walking program for people with Parkinson's disease in Jordan.
AIM This study aim ed to evaluate the feasibility and cultural considerations of a minimally supervised , home-based exercise program in Jordan . METHODS Quantitative and qualitative approaches were used . Thirty participants were r and omly allocated to either an 8-week intervention group ( n = 16 ) , or a st and ard care group ( n = 14 ) . The intervention incorporated the home use of an exercise DVD , walking program and initial instructional sessions and weekly phone calls provided by a physiotherapist . Interviews were used to explore feasibility . Unified Parkinson 's disease rating scale ( UPDRS-III ) ; balance and walking speed were assessed . RESULTS The retention rate was 86.7 % and mean adherence rate was 77 % . Personal and sociocultural barriers of adherence to the exercise program were identified . UPDRS-III at follow-up was lower in the intervention group . CONCLUSION A home exercise program was feasible . Sociocultural barriers specific to Arabic culture may affect the uptake of such an intervention in Parkinson 's disease in these countries
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
650
29,962,227
Long-term effects of highly challenging balance training in Parkinson’s disease—a randomized controlled trial
Objectives : To determine long-term effects of a highly challenging training program in people with Parkinson ’s disease , as well as describe how initially observed improvements of the program deteriorated over time . Design : Long-term follow-up of previously reported outcomes at 10 weeks of a r and omized controlled trial . Setting : University hospital setting . Participants : One-hundred elderly with mild-to-moderate ( Hoehn and Yahr 2–3 ) Parkinson ’s disease . Interventions : Participants in the training group ( n = 51 ) received 10 weeks ( three times/week ) of balance and gait exercises , incorporating dual-tasks , while the control group ( n = 49 ) received care as usual . Main Outcome Measures : Balance control ( Mini-Balance Evaluation System Test ( Mini-BESTest ) ) and gait velocity . Mixed- design analyses of variance were used to determine potential training effects at 6- and 12-month follow-up , and piecewise regression models predicted the rate of deterioration . Results : Seventy-six participants were included at final follow-up . No significant ( P > .05 ) between-group differences remained at either 6 or 12 months following the intervention . The mean Mini-BESTest scores of the training and control group were 19.9 ( SD 4.4 ) and 18.6 ( SD 4.3 ) , respectively , at the 12-month follow-up . Gait speed was 1.2 ( SD 0.2 ) m/s in both groups at 12 months . The training group showed a larger deterioration rate per month in balance performance ( 0.21 point ) and gait velocity ( 0.65 cm/s ) than controls ( P < .05 ) . Conclusion : These results suggest that training effects diminish within 6 months after balance training , implying that the program may need to be repeated regularly
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
651
6,282,235
Early predictors of mortality in parkinsonism and Parkinson disease
Objective To examine mortality and associated risk factors , including possible effects of mild cognitive impairment , imaging , and CSF abnormalities , in a community-based population with incident parkinsonism and Parkinson disease . Methods One hundred eighty-two patients with new-onset , idiopathic parkinsonism were diagnosed from January 2004 through April 2009 , in a catchment area of 142,000 inhabitants in Sweden . Patients were comprehensively investigated according to a multimodal research protocol and followed prospect ively for up to 13.5 years . A total of 109 patients died . Mortality rates in the general Swedish population were used to calculate st and ardized mortality ratio and expected survival , and Cox proportional hazard models were used to investigate independent predictors of mortality . Results The st and ardized mortality ratio for all patients was 1.84 ( 95 % confidence interval 1.50–2.22 , p < 0.001 ) . Patients with atypical parkinsonism ( multiple system atrophy or progressive supranuclear palsy ) had the highest mortality . In early Parkinson disease , a mild cognitive impairment diagnosis , freezing of gait , hyposmia , reduced dopamine transporter activity in the cau date , and elevated leukocytes in the CSF were significantly associated with shorter survival . Conclusion Although patients presenting with idiopathic parkinsonism have reduced survival , the survival is highly dependent on the type and characteristics of the parkinsonian disorder . Patients with Parkinson disease presenting with normal cognitive function seem to have a largely normal life expectancy . The finding of a subtle CSF leukocytosis in patients with Parkinson disease with short survival may have clinical implication
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
35
31,521,554
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
652
6,585,265
Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson’s
Objective To estimate the effect of a physiotherapist-delivered fall prevention programme for people with Parkinson ’s ( PwP ) . Methods People at risk of falls with confirmed Parkinson ’s were recruited to this multicentre , pragmatic , investigator blind , individually r and omised controlled trial with prespecified subgroup analyses . 474 PwP ( Hoehn and Yahr 1–4 ) were r and omised : 238 allocated to a physiotherapy programme and 236 to control . All participants had routine care ; the control group received a DVD about Parkinson ’s and single advice session at trial completion . The intervention group ( PDSAFE ) had an individually tailored , progressive home-based fall avoidance strategy training programme with balance and strengthening exercises . The primary outcome was risk of repeat falling , collected by self-report monthly diaries , 0–6 months after r and omisation . Secondary outcomes included Mini-BESTest for balance , chair st and test , falls efficacy , freezing of gait , health-related quality of life ( EuroQol EQ-5D ) , Geriatric Depression Scale , Physical Activity Scale for the Elderly and Parkinson ’s Disease Question naire , fractures and rate of near falling . Results Average age is 72 years and 266 ( 56 % ) were men . By 6 months , 116 ( 55 % ) of the control group and 125 ( 61.5 % ) of the intervention group reported repeat falls ( controlled OR 1.21 , 95 % CI 0.74 to 1.98 , p=0.447 ) . Secondary subgroup analyses suggested a different response to the intervention between moderate and severe disease severity groups . Balance , falls efficacy and chair st and time improved with near falls reduced in the intervention arm . Conclusion PDSAFE did not reduce falling in this pragmatic trial of PwP. Other functional tasks improved and reduced fall rates were apparent among those with moderate disease . Trial registration number IS RCT N48152791
35
Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .
QUESTIONS In people with Parkinson 's disease , does home-based prescribed exercise improve balance-related activities and quality of life compared with no intervention ? Are the effects of home-based exercise similar to those of equivalent centre-based exercise ?
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
653
22,309,242
Restoration of adipose function in obese glucose-tolerant men following pioglitazone treatment is associated with CCAAT enhancer-binding protein β up-regulation.
Obese AT ( adipose tissue ) exhibits increased macrophage number . Pro-inflammatory CD16 + peripheral monocyte numbers are also reported to increase with obesity . The present study was undertaken to simultaneously investigate obesity-associated changes in CD16 + monocytes and ATMs ( AT macrophages ) . In addition , a pilot r and omized placebo controlled trial using the PPAR ( peroxisome-proliferator-activated receptor ) agonists , pioglitazone and fenofibrate was performed to determine their effects on CD14+/CD16 + monocytes , ATM and cardiometabolic and adipose dysfunction indices . Obese glucose-tolerant men ( n=28 ) were r and omized to placebo , pioglitazone ( 30 mg/day ) and fenofibrate ( 160 mg/day ) for 12 weeks . A blood sample was taken to assess levels of serum inflammatory markers and circulating CD14+/CD16 + monocyte levels via flow cytometry . A subcutaneous AT biopsy was performed to determine adipocyte cell surface and ATM number , the latter was determined via assessment of CD68 expression by IHC ( immunohistochemistry ) and real-time PCR . Subcutaneous AT mRNA expression of CEBPβ ( CCAAT enhancer-binding protein β ) , SREBP1c ( sterol-regulatory-element-binding protein 1c ) , PPARγ2 , IRS-1 ( insulin receptor substrate-1 ) , GLUT4 ( glucose transporter type 4 ) and TNFα ( tumour necrosis factor α ) were also assessed . Comparisons were made between obese and lean controls ( n=16 ) at baseline , and pre- and post-PPAR agonist treatment . Obese individuals had significantly increased adipocyte cell surface , percentage CD14+/CD16 + monocyte numbers and ATM number ( all P=0.0001 ) . Additionally , serum TNF-α levels were significantly elevated ( P=0.017 ) and adiponectin levels reduced ( total : P=0.0001 ; high : P=0.022 ) with obesity . ATM number and percentage of CD14+/CD16 + monocytes correlated significantly ( P=0.05 ) . Pioglitazone improved adiponectin levels significantly ( P=0.0001 ) , and result ed in the further significant enlargement of adipocytes ( P=0.05 ) , without effect on the percentage CD14+/CD16 + or ATM number . Pioglitazone treatment also significantly increased subcutaneous AT expression of CEBPβ mRNA . The finding that improvements in obesity-associated insulin resistance following pioglitazone were associated with increased adipocyte cell surface and systemic adiponectin levels , supports the central ity of AT to the cardiometabolic derangement underlying the development of T2D ( Type 2 diabetes ) and CVD ( cardiovascular disease )
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
654
12,351,435
The effect of thiazolidinediones on plasma adiponectin levels in normal, obese, and type 2 diabetic subjects.
The insulin-sensitizing effects of thiazolidinediones are thought to be mediated through peroxisome proliferator-activated receptor-gamma , a nuclear receptor that is highly abundant in adipose tissue . It has been reported that adipocytes secrete a variety of proteins , including tumor necrosis factor-alpha , resistin , plasminogen activator inhibitor-1 , and adiponectin . Adiponectin is a fat cell-secreted protein that has been reported to increase fat oxidation and improve insulin sensitivity . Our aim was to study the effects of troglitazone on adiponectin levels in lean , obese , and diabetic subjects . Ten diabetic and 17 nondiabetic subjects ( 8 lean , BMI < 27 kg/m(2 ) and 9 obese , BMI > 27 kg/m(2 ) ) participated in the study . All subjects underwent an 80 mU. m(-2 ) . min(-1 ) hyperinsulinemic-euglycemic glucose clamp before and after 3 months ' treatment with the thiazolidinedione ( TZD ) troglitazone ( 600 mg/day ) . Fasting plasma glucose significantly decreased in the diabetic group after 12 weeks of treatment compared with baseline ( 9.1 + /- 0.9 vs. 11.1 + /- 0.9 mmol/l , P < 0.005 ) but was unchanged in the lean and obese subjects . Fasting insulin for the entire group was significantly lower than baseline ( P = 0.02 ) after treatment . At baseline , glucose disposal rate ( R(d ) ) was lower in the diabetic subjects ( 3.4 + /- 0.5 mg . kg(-1 ) . min(-1 ) ) than in the lean ( 12.3 + /- 0.4 ) or obese subjects ( 6.7 + /- 0.7 ) ( P < 0.001 for both ) and was significantly improved in the diabetic and obese groups ( P < 0.05 ) after treatment , and it remained unchanged in the lean subjects . Baseline adiponectin levels were significantly lower in the diabetic than the lean subjects ( 9.0 + /- 1.7 vs. 16.7 + /- 2.7 micro g/ml , P = 0.03 ) and rose uniformly in all subjects ( 12.2 + /- 2.3 vs. 25.7 + /- 2.6 micro g/ml , P < 10(-4 ) ) after treatment , with no significant difference detected among the three groups . During the glucose clamps , adiponectin levels were suppressed below basal levels in all groups ( 10.2 + /- 2.3 vs. 12.2 + /- 2.3 micro g/ml , P < 0.01 ) . Adiponectin levels correlated with R(d ) ( r = 0.46 , P = 0.016 ) and HDL cholesterol levels ( r = 0.59 , P < 0.001 ) and negatively correlated with fasting insulin ( r = -0.39 , P = 0.042 ) and plasma triglyceride ( r = -0.61 , P < 0.001 ) . Our findings show that TZD treatment increased adiponectin levels in all subjects , including normal subjects in which no other effects of TZDs are observed . Insulin also appears to suppress adiponectin levels . We have confirmed these results in normal rats . These findings suggest that adiponectin can be regulated by obesity , diabetes , TZDs , and insulin , and it may play a physiologic role in enhancing insulin sensitivity
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
655
15,920,062
Beneficial effects of fenofibrate to improve endothelial dysfunction and raise adiponectin levels in patients with primary hypertriglyceridemia.
OBJECTIVE Improvement in endothelial function is predicted to improve insulin sensitivity , and this may be one mechanism by which fenofibrate decreases the incidence of coronary heart disease . We hypothesize fenofibrate improves endothelial function by enhancing insulin sensitivity . RESEARCH DESIGN AND METHODS We administered placebo or fenofibrate 200 mg daily for 8 weeks to 46 patients with primary hypertriglyceridemia ( 24 had metabolic syndrome ) . This study was r and omized , double blind , placebo controlled , and crossover in design . RESULTS Compared with placebo , fenofibrate decreased total cholesterol , non-HDL cholesterol , apolipoprotein B , and triglycerides and increased HDL cholesterol and apolipoprotein A-I ( all P < 0.001 ) while tending to decrease LDL cholesterol ( P = 0.069 ) . Fenofibrate significantly improved percent flow-mediated dilator response to hyperemia by 48 + /- 5 % ( P < 0.001 ) and lowered plasma levels of high-sensitivity C-reactive protein ( hsCRP ) relative to baseline measurements from 0.80 to 0.70 mg/l ( P = 0.001 ) and fibrinogen levels by 16 + /- 3 % ( P < 0.001 ) . Compared with placebo , fenofibrate therapy significantly increased plasma levels of adiponectin by 14 + /- 5 % ( P = 0.008 ) and increased insulin sensitivity ( assessed by quantitative insulin sensitivity check index [ QUICKI ] ) by 6 + /- 2 % ( P = 0.048 ) . There were significant correlations between percent changes in adiponectin levels and percent changes in flow-mediated dilation ( r = 0.401 , P = 0.006 ) , hsCRP ( r = -0.443 , P = 0.002 ) , or QUICKI ( r = 0.292 , P = 0.049 ) . Multivariate regression analysis showed that only changes in adiponectin levels persisted as an independent predictor of changes in flow-mediated dilation ( r = 0.504 , P = 0.013 ) . Overall , we observed similar results in 24 patients with metabolic syndrome . CONCLUSIONS Fenofibrate therapy significantly improved percent flow-mediated dilator response to hyperemia , reduced inflammation marker levels , increased adiponectin levels , and improved insulin sensitivity in hypertriglyceridemic or metabolic syndrome patients
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
656
3,369,484
Acute Exercise Increases Adiponectin Levels in Abdominally Obese Men
Objective . To examine the effect of acute and short-term ( ~1 week ) aerobic exercise training on plasma adiponectin levels in inactive , abdominally obese men . Material s and Methods . Inactive and abdominally obese men ( n = 38 , waist circumference ≥102 cm ) recruited from Kingston , Canada were r and omly allocated to perform three bouts of aerobic treadmill exercise at either low ( 50 % VO2 peak ) or high ( 75 % VO2 peak ) intensity during a 1-week period . Blood sample s were taken before and after the first exercise session and 24–72 hours following the completion of the final exercise session . Results . Adiponectin levels were elevated immediately following an acute bout of exercise at both high and low intensities ( High : 5.79 ± 0.42 versus 5.05 ± 0.41 ug/mL ; Low : 5.24 ± 0.44 versus 4.37 ± 0.44 ug/mL , P < 0.05 ) and remained elevated following 30 minutes of rest . In comparison to baseline , adiponectin levels were also elevated 24–72 hours following the final exercise session ( High : 5.47 ± 0.48 versus 4.88 ± 0.48 ug/mL ; Low : 5.18 ± 0.49 versus 4.47 ± 0.49 ug/mL , P < 0.05 ) . Conclusion . Both acute and short-term aerobic exercise result in a significant increase in plasma adiponectin levels in inactive , abdominally obese men independent of intensity
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
657
20,228,404
Effects of combination lipid therapy in type 2 diabetes mellitus.
BACKGROUND We investigated whether combination therapy with a statin plus a fibrate , as compared with statin monotherapy , would reduce the risk of cardiovascular disease in patients with type 2 diabetes mellitus who were at high risk for cardiovascular disease . METHODS We r and omly assigned 5518 patients with type 2 diabetes who were being treated with open-label simvastatin to receive either masked fenofibrate or placebo . The primary outcome was the first occurrence of nonfatal myocardial infa rct ion , nonfatal stroke , or death from cardiovascular causes . The mean follow-up was 4.7 years . RESULTS The annual rate of the primary outcome was 2.2 % in the fenofibrate group and 2.4 % in the placebo group ( hazard ratio in the fenofibrate group , 0.92 ; 95 % confidence interval [ CI ] , 0.79 to 1.08 ; P=0.32 ) . There were also no significant differences between the two study groups with respect to any secondary outcome . Annual rates of death were 1.5 % in the fenofibrate group and 1.6 % in the placebo group ( hazard ratio , 0.91 ; 95 % CI , 0.75 to 1.10 ; P=0.33 ) . Prespecified subgroup analyses suggested heterogeneity in treatment effect according to sex , with a benefit for men and possible harm for women ( P=0.01 for interaction ) , and a possible interaction according to lipid subgroup , with a possible benefit for patients with both a high baseline triglyceride level and a low baseline level of high-density lipoprotein cholesterol ( P=0.057 for interaction ) . CONCLUSIONS The combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events , nonfatal myocardial infa rct ion , or nonfatal stroke , as compared with simvastatin alone . These results do not support the routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk in the majority of high-risk patients with type 2 diabetes . ( Clinical Trials.gov number , NCT00000620 .
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
658
21,565,796
Combination of niacin and fenofibrate with lifestyle changes improves dyslipidemia and hypoadiponectinemia in HIV patients on antiretroviral therapy: results of "heart positive," a randomized, controlled trial.
CONTEXT HIV patients on antiretroviral therapy ( ART ) have a unique dyslipidemia [ elevated triglycerides and non-high-density lipoprotein-cholesterol ( HDL-C ) , low HDL-C ] with insulin resistance ( characterized by hypoadiponectinemia ) . OBJECTIVE The aim was to test a targeted , comprehensive , additive approach to treating the dyslipidemia . DESIGN AND SETTING We conducted a r and omized , double-blind , placebo-controlled , 24-wk trial of lifestyle modification , fenofibrate , and niacin in multiethnic HIV clinics at an academic center . PARTICIPANTS Hypertriglyceridemic adult patients were stratified on three combinations of ART classes . Subjects retained at the first measurement ( 2 wk ) after entry were included in the analysis ( n = 191 ) . INTERVENTIONS Subjects were r and omized into five treatment groups : usual care ( group 1 ) ; low-saturated-fat diet and exercise ( D/E ; group 2 ) ; D/E + fenofibrate ( group 3 ) ; D/E + niacin ( group 4 ) ; or D/E + fenofibrate + niacin ( group 5 ) . MAIN OUTCOME MEASURES We measured changes in fasting triglycerides , HDL-C , and non-HDL-C ( primary ) , and in insulin sensitivity , glycemia , adiponectin , C-reactive protein , energy expenditure , and body composition ( secondary ) . Data were analyzed as a factorial set of treatment combinations using a mixed repeated measures model , last observation carried forward , and complete case approaches ( groups 2 - 5 ) , and as an unstructured set of treatments ( groups 1 - 5 ) . RESULTS Fenofibrate improved triglycerides ( P = 0.002 ) , total cholesterol ( P = 0.02 ) , and non-HDL-C ( P = 0.003 ) , whereas niacin improved HDL-C ( P = 0.03 ) , and both drugs decreased the total cholesterol-to-HDL-C ratio ( P = 0.005 - 0.01 ) . The combination of D/E , fenofibrate , and niacin provided maximal benefit , markedly reducing triglycerides ( -52 % compared to usual care ; P = 0.003 ) , increasing HDL-C ( + 12 % ; P < 0.001 ) , and decreasing non-HDL-C ( -18.5 % ; P = 0.003 ) and total cholesterol-to-HDL-C ratio ( -24.5 % ; P < 0.001 ) . Niacin doubled adiponectin levels . CONCLUSIONS A combination of fenofibrate and niacin with low-saturated-fat D/E is effective and safe in increasing HDL-C , decreasing non-HDL-C and hypertriglyceridemia , and ameliorating hypoadiponectinemia in patients with HIV/ART-associated dyslipidemia
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
659
10,880,410
Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease.
BACKGROUND Coronary heart disease patients with low high-density lipoprotein cholesterol ( HDL-C ) levels , high triglyceride levels , or both are at an increased risk of cardiovascular events , but the clinical impact of raising HDL-C or decreasing triglycerides remains to be confirmed . METHODS AND RESULTS In a double-blind trial , 3090 patients with a previous myocardial infa rct ion or stable angina , total cholesterol of 180 to 250 mg/dL , HDL-C < or = 45 mg/dL , triglycerides < or = 300 mg/dL , and low-density lipoprotein cholesterol < or = 180 mg/dL were r and omized to receive either 400 mg of bezafibrate per day or a placebo ; they were followed for a mean of 6.2 years . The primary end point was fatal or nonfatal myocardial infa rct ion or sudden death . Bezafibrate increased HDL-C by 18 % and reduced triglycerides by 21 % . The frequency of the primary end point was 13 . 6 % on bezafibrate versus 15.0 % on placebo ( P=0.26 ) . After 6.2 years , the reduction in the cumulative probability of the primary end point was 7.3 % , ( P=0.24 ) . In a post hoc analysis in the subgroup with high baseline triglycerides ( > or = 200 mg/dL ) , the reduction in the cumulative probability of the primary end point by bezafibrate was 39.5 % ( P=0.02 ) . Total and noncardiac mortality rates were similar , and adverse events and cancer were equally distributed . CONCLUSIONS Bezafibrate was safe and effective in elevating HDL-C levels and lowering triglycerides . An overall trend in a reduction of the incidence of primary end points was observed . The reduction in the primary end point in patients with high baseline triglycerides ( > or = 200 mg/dL ) requires further confirmation
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
660
15,082,700
Plasma adiponectin levels and risk of myocardial infarction in men.
CONTEXT Adiponectin , a recently discovered adipocyte-derived peptide , is involved in the regulation of insulin sensitivity and lipid oxidation and , purportedly , in the development of atherosclerosis and coronary heart disease in humans . OBJECTIVE To assess prospect ively whether plasma adiponectin concentrations are associated with risk of myocardial infa rct ion ( MI ) . DESIGN , SETTING , AND PARTICIPANTS Nested case-control study among 18 225 male participants of the Health Professionals Follow-up Study aged 40 to 75 years who were free of diagnosed cardiovascular disease at the time of blood draw ( 1993 - 1995 ) . During 6 years of follow-up through January 31 , 2000 , 266 men subsequently developed nonfatal MI or fatal coronary heart disease . Using risk set sampling , controls were selected in a 2:1 ratio matched for age , date of blood draw , and smoking status ( n = 532 ) . MAIN OUTCOME MEASURE Incidence of nonfatal MI and fatal coronary heart disease by adiponectin level . RESULTS After adjustment for matched variables , participants in the highest compared with the lowest quintile of adiponectin levels had a significantly decreased risk of MI ( relative risk [ RR ] , 0.39 ; 95 % confidence interval [ CI ] , 0.23 - 0.64 ; P for trend < .001 ) . Additional adjustment for family history of MI , body mass index , alcohol consumption , physical activity , and history of diabetes and hypertension did not substantively affect this relationship ( RR , 0.41 ; 95 % CI , 0.24 - 0.70 ; P for trend < .001 ) . Further adjustment for hemoglobin A1c or C-reactive protein levels also had little impact , but additional adjustment for low- and high-density lipoprotein cholesterol levels modestly attenuated this association ( RR , 0.56 ; 95 % CI , 0.32 - 0.99 ; P for trend = .02 ) . CONCLUSIONS High plasma adiponectin concentrations are associated with lower risk of MI in men . This relationship can be only partly explained by differences in blood lipids and is independent of inflammation and glycemic status
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
661
17,184,146
Influence of PPAR-alpha agonist fenofibrate on insulin sensitivity and selected adipose tissue-derived hormones in obese women with type 2 diabetes.
PPAR-alpha agonists improve insulin sensitivity in rodent models of obesity/insulin resistance , but their effects on insulin sensitivity in humans are less clear . We measured insulin sensitivity by hyperinsulinemic-isoglycemic clamp in 10 obese females with type 2 diabetes before and after three months of treatment with PPAR-alpha agonist fenofibrate and studied the possible role of the changes in endocrine function of adipose tissue in the metabolic effects of fenofibrate . At baseline , body mass index , serum glucose , triglycerides , glycated hemoglobin and atherogenic index were significantly elevated in obese women with type 2 diabetes , while serum HDL cholesterol and adiponectin concentrations were significantly lower than in the control group ( n=10 ) . No differences were found in serum resistin levels between obese and control group . Fenofibrate treatment decreased serum triglyceride concentrations , while both blood glucose and glycated hemoglobin increased after three months of fenofibrate administration . Serum adiponectin or resistin concentrations were not significantly affected by fenofibrate treatment . All parameters of insulin sensitivity as measured by hyperinsulinemic-isoglycemic clamp were significantly lower in an obese diabetic group compared to the control group before treatment and were not affected by fenofibrate administration . We conclude that administration of PPAR-alpha agonist fenofibrate for three months did not significantly affect insulin sensitivity or resistin and adiponectin concentrations in obese subjects with type 2 diabetes mellitus . The lack of insulin-sensitizing effects of fenofibrate in humans relative to rodents could be due to a generally lower PPAR-alpha expression in human liver and muscle
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
662
22,153,696
Significant differential effects of omega-3 fatty acids and fenofibrate in patients with hypertriglyceridemia.
BACKGROUND Omega-3 fatty acids and fenofibrate are both used to treat patients with hypertriglyceridemia . However , a head-to-head comparison of the lipoprotein and metabolic effects of these two medicines has not been published . METHODS This was a r and omized , single-blind , placebo-controlled , parallel study . Age , sex , and body mass index were matched among groups . All patients were recommended to maintain a low fat diet . Fifty patients in each group were given placebo , omega-3 fatty acids 2 g ( most commonly used dosage in Korean patients ) , or fenofibrate 160 mg , respectively daily for 2 months . RESULTS Omega-3 fatty acids therapy decreased triglycerides by 21 % and triglycerides/HDL cholesterol and improved flow-mediated dilation ( P<0.01 ) , however , did not significantly change insulin , plasma adiponectin levels , and insulin sensitivity ( determined by QUICKI ) relative to baseline measurements . Fenofibrate therapy decreased total cholesterol , triglycerides by 29 % , and triglycerides/HDL-cholesterol ( all P<0.01 ) and improved flow-mediated dilation when compared with baseline . When compared with placebo and omega-3 fatty acids , fenofibrate therapy decreased non-HDL cholesterol ( P<0.001 ) and triglycerides/HDL cholesterol ( P=0.016 ) while increasing HDL cholesterol ( P<0.001 ) and apolipoprotein AI ( P=0.001 ) . Of note , when compared with omega-3 fatty acids , fenofibrate therapy decreased fasting insulin ( P=0.023 ) and increased plasma adiponectin ( P=0.002 ) and insulin sensitivity ( P=0.015 ) . CONCLUSIONS Omega-3 fatty acids and fenofibrate therapy promoted similar changes in triglycerides and endothelium-dependent dilation . However , fenofibrate therapy had substantially better effects on lipoprotein and metabolic profiles in patients with hypertriglyceridemia
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
663
16,606,809
Attenuation of progression of insulin resistance in patients with coronary artery disease by bezafibrate.
BACKGROUND Development of insulin resistance ( IR ) may be important in the pathogenesis of both metabolic syndrome and type 2 diabetes mellitus . Few data are available regarding the short-term efficacy of the peroxisome proliferator-activated receptor lig and bezafibrate on IR , and its long-term effect is unknown . The present analysis aim ed to investigate the effect of bezafibrate on IR in patients with coronary artery disease enrolled in the Bezafibrate Infa rct ion Prevention Study . METHODS Metabolic and inflammatory parameters were analyzed from stored frozen plasma sample s obtained from patients who completed a 2-year , r and omized , double-blind , placebo-controlled study . The homeostatic indexes of IR ( HOMA-IRs ) were calculated according to the homeostasis model of assessment . RESULTS Both the patients taking bezafibrate ( n = 1262 ) and those taking placebo ( n = 1242 ) displayed similar baseline characteristics . The HOMA-IRs significantly correlated at baseline and during follow-up with glucose ( r = 0.35 and 0.31 , respectively ) and triglycerides ( r = 0.16 and 0.19 , respectively ) . In a subgroup of 351 patients with diabetes , HOMA-IR at baseline was 88 % higher than in their counterparts with normal glucose levels ( P<.001 ) . In the placebo group , during follow-up there was a significant 34.4 % rise in HOMA-IR . In contrast , in the bezafibrate group there was only a nonsignificant 6.6 % change in HOMA-IR . The intergroup differences in percentage changes of HOMA-IR were in favor of bezafibrate ( P<.001 ) . CONCLUSIONS In patients with coronary artery disease enrolled in our study , as represented by the placebo group , HOMA-IR increased over time . During the 2 years of the follow-up , bezafibrate significantly attenuated this process
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
664
15,123,532
Peroxisome Proliferator–Activated Receptor Ligand Bezafibrate for Prevention of Type 2 Diabetes Mellitus in Patients With Coronary Artery Disease
Background —Recent studies have shown that type 2 diabetes is preventable by both lifestyle interventions and medications that influence primary glucose metabolism . Whether pharmacological interventions that influence primary lipid metabolism can also delay development of type 2 diabetes is unknown . The goal of this study was to evaluate the effect of the peroxisome proliferator – activated receptor lig and bezafibrate on the progression of impaired fasting glucose phase to type 2 diabetes in patients with coronary artery disease over a 6.2-year follow-up period . Methods and Results —The study sample comprised 303 nondiabetic patients 42 to 74 years of age with a fasting blood glucose level of 110 to 125 mg/dL ( 6.1 to 6.9 mmol/L ) . The patients received either 400 mg bezafibrate retard ( 156 patients ) or placebo ( 147 patients ) once a day . No patients were using statins , and use of ACE inhibitors , which also reduce diabetes incidence , was relatively low . During follow-up , development of new-onset diabetes was recorded in 146 patients : in 80 ( 54.4 % ) from the placebo group and 66 ( 42.3 % ) from the bezafibrate group ( P = 0.04 ) . The mean time until onset of new diabetes was significantly delayed in patients on bezafibrate compared with patients on placebo : 4.6±2.3 versus 3.8±2.6 years ( P = 0.004 ) . Multivariate analysis identified bezafibrate treatment as an independent predictor of reduced risk of new diabetes development ( hazard ratio , 0.70 ; 95 % CI , 0.49 to 0.99 ) . Other significant variables associated with future overt type 2 diabetes in patients with impaired fasting glucose were total cholesterol level ( hazard ratio , 1.22 ; 95 % CI 1.0 to 1.51 ) and body mass index ( hazard ratio , 1.10 ; 95 % CI , 1.05 to 1.16 ) . Conclusions —Bezafibrate reduces the incidence and delays the onset of type 2 diabetes in patients with impaired fasting glucose . Whether the combination of bezafibrate with other recommended drugs for secondary prevention ( statins and ACE inhibitors ) would be as efficacious as suggested by our results remains to be determined
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
665
22,341,868
Apolipoprotein B-48 as a determinant of endothelial function in obese subjects with type 2 diabetes mellitus: effect of fenofibrate treatment.
OBJECTIVE Elevated triglyceride-rich lipoproteins may contribute to endothelial dysfunction in obese diabetic subjects . We investigated the association between plasma concentrations of chylomicron-related particles and endothelial function , and the corresponding responses to fenofibrate treatment . METHODS Plasma apolipoprotein ( apo ) B-48 and remnant-like particle (RLP)-cholesterol concentrations were measured in 28 obese subjects with T2DM . Flow-mediated endothelium-dependent dilation ( FMD ) and glyceryl-trinitrate mediated dilatation ( GTNMD ) in the brachial artery during reactive hyperaemia were examined by high-resolution ultrasound technique . RESULTS In univariate analysis , plasma apoB-48 and RLP-cholesterol concentrations were inversely associated with brachial artery FMD ( r = -0.425 and -0.423 , respectively , P<0.05 ) , but not with GTNMD . In regression models including BMI and HOMA score , plasma apoB-48 was an independent predictors ( P<0.05 ) of brachial artery FMD ( β coefficient = -0.384 ) . Replacing HOMA-IR score with plasma triglyceride , adiponectin or CRP concentrations did not alter the findings . The subjects were then r and omized to a 12-week treatment period of either 200 mg micronized fenofibrate or matching placebo . Compared with the placebo group , fenofibrate treatment ( 200 mg daily for 12 weeks ) achieved significant increase in FMD ( + 34 % ) and reduction in plasma triglyceride ( -42 % ) , apoB-48 ( -52 % ) and RLP-cholesterol ( -51 % ) concentrations . The increase in FMD with fenofibrate was significantly associated with the corresponding decrease in plasma apoB-48 ( r = -0.644 , P<0.02 ) concentrations . CONCLUSIONS Our findings demonstrate an association between changes in lipid metabolism and improvement in endothelial function in patients with diabetic dyslipidaemia treated with fenofibrate that may involve the effect of apoB-48 on endothelium-dependent vasodilator function
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
666
1,710,742
Bezafibrate Retard in Type II Diabetic Patients: Effects on Hemostasis and Glucose Homeostasis
A double-blind , placebo-controlled trial assessed the effect of a slow-release formulation of bezafibrate ( Bezalip Mono , 400 mg daily for 3 months ) on lipid profile , glucose homeostasis , platelet function , and plasma fibrinogen concentration in non-insulin-dependent ( type II ) diabetics . Twenty-four patients completed the trial . There was a significant improvement in the cholesterol ( p < 0.02 ) , triglyceride ( p < 0.01 ) , and nonesterified fatty acid ( p < 0.05 ) concentrations and in the fasting blood glucose ( p < 0.03 ) and glycosylated hemoglobin ( p < 0.01 ) levels of those ( n = 11 ) who received the active preparation but not in those ( n = 13 ) who received placebo . Treatment , but not placebo , also result ed in a significant ( p < 0.01 ) fall in plasma fibrinogen concentration and a trend towards inhibition of platelet aggregation . Bezafibrate was well tolerated ; only one patient ( not included in the analysis of results ) withdrew from the trial possibly because of side effects of the drug . A larger study is needed to establish whether bezafibrate can reduce nonlipid risk factors ( e.g. , plasma fibrinogen concentration , glucose intolerance , and hyperinsulinemia ) in normo- and hyperlipidemic subjects
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
667
17,145,061
Fenofibrate and pioglitazone improve endothelial function and reduce arterial stiffness in obese glucose tolerant men.
Obesity is a low grade inflammatory state associated with premature cardiovascular morbidity and mortality . Along with traditional risk factors the measurement of endothelial function , insulin resistance , inflammation and arterial stiffness may contribute to the assessment of cardiovascular risk . We conducted a r and omised placebo controlled trial to assess the effects of 12 weeks treatment with a PPAR alpha agonist ( fenofibrate ) and a PPAR gamma agonist ( pioglitazone ) on these parameters in obese glucose tolerant men . Arterial stiffness was measured using augmentation index and pulse wave velocity ( PWV ) . E-selectin , VCAM-1 and ICAM-1 were used as markers of endothelial function . Insulin sensitivity improved with pioglitazone treatment ( p=0.001 ) and , in keeping with this , adiponectin increased by 85.2 % ( p<0.001 ) . Pro-inflammatory cytokine levels ( TNFalpha , IL-6 and IL-1 beta ) fell with both treatments ( p<0.01 for TNFalpha and IL-1 beta , p<0.001 for IL-6 ) . VCAM-1 and ICAM-1 were reduced with both treatments ( p<0.001 for VCAM-1 , p<0.05 for ICAM-1 ) and E-selectin improved with pioglitazone treatment ( p=0.05 ) . Both treatments result ed in a fall in augmentation index . PWV fell by 17.4 % with fenofibrate treatment ( p<0.001 ) and 16.3 % with pioglitazone treatment ( p<0.001 ) . Pioglitazone and fenofibrate treatment of obese , glucose tolerant men reduces inflammation , improves markers of endothelial function and reduces arterial stiffness . These results suggest that treatment with PPAR agonists has potential to reduce the incidence of premature cardiovascular disease associated with obesity
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
668
16,310,551
Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial.
BACKGROUND Patients with type 2 diabetes mellitus are at increased risk of cardiovascular disease , partly owing to dyslipidaemia , which can be amenable to fibrate therapy . We design ed the Fenofibrate Intervention and Event Lowering in Diabetes ( FIELD ) study to assess the effect of fenofibrate on cardiovascular disease events in these patients . METHODS We did a multinational , r and omised controlled trial with 9795 participants aged 50 - 75 years , with type 2 diabetes mellitus , and not taking statin therapy at study entry . After a placebo and a fenofibrate run-in phase , we r and omly assigned patients ( 2131 with previous cardiovascular disease and 7664 without ) with a total-cholesterol concentration of 3.0 - 6.5 mmol/L and a total-cholesterol/HDL-cholesterol ratio of 4.0 or more or plasma triglyceride of 1.0 - 5.0 mmol/L to micronised fenofibrate 200 mg daily ( n=4895 ) or matching placebo ( n=4900 ) . Our primary outcome was coronary events ( coronary heart disease death or non-fatal myocardial infa rct ion ) ; the outcome for prespecified subgroup analyses was total cardiovascular events ( the composite of cardiovascular death , myocardial infa rct ion , stroke , and coronary and carotid revascularisation ) . Analysis was by intention to treat . The study was prospect ively registered ( number IS RCT N 64783481 ) . FINDINGS Vital status was confirmed on all but 22 patients . Averaged over the 5 years ' study duration , similar proportions in each group discontinued study medication ( 10 % placebo vs 11 % fenofibrate ) and more patients allocated placebo ( 17 % ) than fenofibrate ( 8 % ; p<0.0001 ) commenced other lipid treatments , predominantly statins . 5.9 % ( n=288 ) of patients on placebo and 5.2 % ( n=256 ) of those on fenofibrate had a coronary event ( relative reduction of 11 % ; hazard ratio [ HR ] 0.89 , 95 % CI 0.75 - 1.05 ; p=0.16 ) . This finding corresponds to a significant 24 % reduction in non-fatal myocardial infa rct ion ( 0.76 , 0.62 - 0.94 ; p=0.010 ) and a non-significant increase in coronary heart disease mortality ( 1.19 , 0.90 - 1.57 ; p=0.22 ) . Total cardiovascular disease events were significantly reduced from 13.9 % to 12.5 % ( 0.89 , 0.80 - 0.99 ; p=0.035 ) . This finding included a 21 % reduction in coronary revascularisation ( 0.79 , 0.68 - 0.93 ; p=0.003 ) . Total mortality was 6.6 % in the placebo group and 7.3 % in the fenofibrate group ( p=0.18 ) . Fenofibrate was associated with less albuminuria progression ( p=0.002 ) , and less retinopathy needing laser treatment ( 5.2%vs 3.6 % , p=0.0003 ) . There was a slight increase in pancreatitis ( 0.5%vs 0.8 % , p=0.031 ) and pulmonary embolism ( 0.7%vs 1.1 % , p=0.022 ) , but no other significant adverse effects . INTERPRETATION Fenofibrate did not significantly reduce the risk of the primary outcome of coronary events . It did reduce total cardiovascular events , mainly due to fewer non-fatal myocardial infa rct ions and revascularisations . The higher rate of starting statin therapy in patients allocated placebo might have masked a moderately larger treatment benefit
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
36
23,958,262
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
669
21,075,373
Effects of fenofibrate therapy on circulating adipocytokines in patients with primary hypertriglyceridemia.
BACKGROUND We investigated effects of fenofibrate therapy on endothelial dysfunction and adipocytokine profiles . METHODS A r and omized , single-blind , placebo-controlled , cross-over study was conducted in 53 patients with primary hypertriglyceridemia . We administered placebo or fenofibrate 160 mg daily for 8 weeks . RESULTS When compared with placebo , fenofibrate therapy substantially lowered plasma levels of TNF-α by 6±3 % ( P=0.014 ) and hsCRP from 1.10 to 0.90mg/l ( P=0.004 ) . When compared with placebo , fenofibrate therapy increased plasma levels of adiponectin by 17±4 % ( P=0.001 ) , insulin sensitivity by 4±1 % ( as assessed by QUICKI , P=0.009 ) , and decreased plasma levels of leptin and resistin by 4±7 % ( P=0.022 ) and 10±3 % ( P=0.001 ) , respectively . There were correlations between percent changes in QUICKI and percent changes in adiponectin levels ( r=0.279 , P=0.043 ) or leptin ( r=-0.280 , P=0.042 ) . CONCLUSIONS Fenofibrate therapy significantly reduced pro-inflammatory biomarkers and improved adipocytokines levels and insulin sensitivity in hypertriglyceridemic patients
36
The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .
BACKGROUND Several lines of evidence have indicated the insulin-sensitizing , anti-diabetic and anti-atherosclerotic properties of adiponectin , as well as the inverse association between circulating levels of this adipokine and development of cardiovascular outcomes . Improvement of adiponectin status has been reported as a pleiotropic effect of fibrate therapy , but the findings have not been conclusive . OBJECTIVE To systematic ally review and meta-analyze available evidence from r and omized placebo-controlled trials ( RCTs ) on the impact of fibrate therapy on circulating levels of adiponectin .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
670
11,991,447
Combined Calcium and Vitamin D3 Supplementation in Elderly Women: Confirmation of Reversal of Secondary Hyperparathyroidism and Hip Fracture Risk: The Decalyos II Study
Vitamin D insufficiency and low calcium intake contribute to increase parathyroid function and bone fragility in elderly people . Calcium and vitamin D supplements can reverse secondary hyperparathyroidism thus preventing hip fractures , as proved by Decalyos I. Decalyos II is a 2-year , multicenter , r and omized , double-masked , placebo-controlled confirmatory study . The intention-to-treat population consisted of 583 ambulatory institutionalized women ( mean age 85.2 years , SD = 7.1 ) r and omized to the calcium – vitamin D3 fixed combination group ( n= 199 ) ; the calcium plus vitamin D3 separate combination group ( n= 190 ) and the placebo group ( n= 194 ) . Fixed and separate combination groups received the same daily amount of calcium ( 1200 mg ) and vitamin D3 ( 800 IU ) , which had similar pharmacodynamic effects . Both types of calcium-vitamin D3 regimens increased serum 25-hydroxyvitamin D and decreased serum intact parathyroid hormone to a similar extent , with levels returning within the normal range after 6 months . In a subgroup of 114 patients , femoral neck bone mineral density ( BMD ) decreased in the placebo group ( mean = –2.36 % per year , SD = 4.92 ) , while remaining unchanged in women treated with calcium-vitamin D3 ( mean = 0.29 % per year , SD = 8.63 ) . The difference between the two groups was 2.65 % ( 95 % CI = –0.44 , 5.75 % ) with a trend in favor of the active treatment group . No significant difference between groups was found for changes in distal radius BMD and quantitative ultrasonic parameters at the os calcis . The relative risk ( RR ) of HF in the placebo group compared with the active treatment group was 1.69 ( 95 % CI = 0.96 , 3.0 ) , which is similar to that found in Decalyos I ( RR = 1.7 ; 95 % CI = 1.0 , 2.8 ) . Thus , these data are in agreement with those of Decalyos I and indicate that calcium and vitamin D3 in combination reverse senile secondary hyperparathyroidism and reduce both hip bone loss and the risk of hip fracture in elderly institutionalized women
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
671
20,103,775
The Effects of Vitamin D Supplementation on Physical Function and Quality of Life in Older Patients With Heart Failure: A Randomized Controlled Trial
Background —Low 25-hydroxyvitamin D levels , commonly found in older patients with heart failure , may contribute to the chronic inflammation and skeletal myopathy that lead to poor exercise tolerance . We tested whether vitamin D supplementation of patients with heart failure and vitamin D insufficiency can improve physical function and quality of life . Methods and Results —In a r and omized , parallel group , double-blind , placebo-controlled trial , patients with systolic heart failure aged ≥70 years with 25-hydroxyvitamin D levels < 50 nmol/L ( 20 ng/mL ) received 100000 U of oral vitamin D2 or placebo at baseline and 10 weeks . Outcomes measured at baseline , 10 weeks , and 20 weeks were 6-minute walk distance , quality of life ( Minnesota score ) , daily activity measured by accelerometry , Functional Limitations Profile , B-type natriuretic peptide , and tumor necrosis factor-&agr;. Participants in the vitamin D group had an increase in their 25-hydroxyvitamin D levels compared with placebo at 10 weeks ( 22.9 versus 2.3 nmol/L [ 9.2 versus 0.9 ng/mL ] ; P<0.001 ) and maintained this increase at 20 weeks . The 6-minute walk did not improve in the treatment group relative to placebo . No significant benefit was seen on timed up and go testing , subjective measures of function , daily activity , or tumor necrosis factor . Quality of life worsened by a small , but significant amount in the treatment group relative to placebo . B-type natriuretic peptide decreased in the treatment group relative to placebo ( −22 versus + 78 pg/mL at 10 weeks ; P=0.04 ) . Conclusions —Vitamin D supplementation did not improve functional capacity or quality of life in older patients with heart failure with vitamin D insufficiency . Clinical Trial Registration —www.controlled-trials.com . Identifier : IS RCT N51372896
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
672
23,678,033
Low serum levels of 25-hydroxyvitamin D predict hip fracture in the elderly: a NOREPOS study.
BACKGROUND Despite considerable interest , the relationship between circulating 25-hydroxyvitamin D and the risk of hip fracture is not fully established . OBJECTIVE The objective of the study was to study the association between serum 25-hydroxyvitamin D concentrations [ s-25(OH)D ] and the risk of hip fracture in Norway , a high-latitude country that has some of the highest hip fracture rates worldwide . METHODS A total of 21 774 men and women aged 65 - 79 years attended 4 community-based health studies during 1994 - 2001 . Information on subsequent hip fractures was retrieved from electronic hospital discharge registers , with a maximum follow-up of 10.7 years . Using a stratified case-cohort design , s-25(OH)D was determined by HPLC-atmospheric pressure chemical ionization-mass spectrometry in stored serum sample s in hip fracture cases ( n = 1175 ; 307 men , 868 women ) and in gender-stratified r and om sample s ( n = 1438 ) . Cox proportional hazards regression adapted for the case-cohort design was performed . RESULTS We observed an inverse association between s-25(OH)D and hip fracture ; those with s-25(OH)D in the lowest quartile ( < 42.2 nmol/L ) had a 38 % [ 95 % confidence interval ( CI ) 9 - 74 % ] increased risk of hip fracture compared with the highest quartile ( ≥67.9 nmol/L ) in a model accounting for age , gender , study center , and body mass index . The association was stronger in men than in women : hazard ratio 1.65 ( 95 % CI 1.04 - 2.61 ) vs hazard ratio 1.25 ( 95 % CI 0.95 - 1.65 ) . CONCLUSION In this prospect i ve case-cohort study of hip fractures , the largest ever reported , we found an increased risk of hip fracture in subjects in the lowest compared with the highest quartile of serum 25-hydroxyvitamin D. In accordance with the findings of previous community-based studies , low vitamin D status was a modest risk factor for hip fracture
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
673
27,861,708
High‐Dose Monthly Vitamin D for Prevention of Acute Respiratory Infection in Older Long‐Term Care Residents: A Randomized Clinical Trial
OBJECTIVES To determine the efficacy and safety of high-dose vitamin D supplementation for prevention of acute respiratory infection ( ARI ) in older long-term care residents . DESIGN R and omized controlled trial investigating high-dose vs st and ard-dose vitamin D from 2010 to 2014 . SETTING Colorado long-term care facilities . PARTICIPANTS Long-term care residents aged 60 and older ( n = 107 ) . INTERVENTION The high-dose group received monthly supplement of vitamin D3 100,000 IU , the st and ard-dose group received a monthly placebo ( for participants taking 400 - 1,000 IU/d as part of usual care ) or a monthly supplement of 12,000 IU of vitamin D3 ( for participants taking < 400 IU/d as part of usual care ) . MEASUREMENTS The primary outcome was incidence of ARI during the 12-month intervention . Secondary outcomes were falls and fractures , 25-hydroxyvitamin D levels , hypercalcemia , and kidney stones . RESULTS Participants ( 55 high dose , 52 st and ard dose ) were r and omized and included in the final analysis . The high-dose group had 0.67 ARIs per person-year and the st and ard-dose group had 1.11 ( incidence rate ratio ( IRR ) = 0.60 , 95 % confidence interval ( CI ) = 0.38 - 0.94 , P = .02 ) . Falls were more common in the high-dose group ( 1.47 per person-year vs 0.63 in st and ard-dose group ; IRR = 2.33 , 95 % CI = 1.49 - 3.63 , P < .001 ) . Fractures were uncommon and similar in both groups ( high dose 0.10 vs st and ard dose 0.19 per person-year ; P = .31 ) . Mean trough 25-hydroxyvitamin D levels during the trial were 32 . ng/mL in the high-dose group and 25.1 ng/mL in the st and ard-dose group . There was no hypercalcemia or kidney stones in either group . CONCLUSION Monthly high-dose vitamin D3 supplementation reduced the incidence of ARI in older long-term care residents but was associated with a higher rate of falls without an increase in fractures
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
674
17,473,911
Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation
Introduction Osteoporotic fractures in older people are a major and increasing public health problem . We examined the effect of vitamin D supplementation on fracture rate in people living in sheltered accommodation . Methods In a pragmatic double blind r and omised controlled trial of 3 years duration , we examined 3,440 people ( 2,624 women and 816 men ) living in residential or care home . We used four-monthly oral supplementation using 100,000 IU vitamin D2 ( ergocalciferol ) . As a main outcome measure , we used the incidence of first fracture using an intention to treat analysis . This was a multicentre study in 314 care homes or sheltered accommodation complexes in South Wales , UK . Results The vitamin D and placebo groups had similar baseline characteristics . In intention-to-treat analysis , 205 first fractures occurred in the intervention group during a total of 2,846 person years of follow-up ( 7 fractures per 100 people per year of follow-up ) , with 218 first fractures in the control group over 2,860 person years of follow-up . The hazard ratio of 0.95 ( 95 % confidence interval 0.79–1.15 ) for intervention compared to control was not statistically significant . ConclusionS upplementation with four-monthly 100,000 IU of oral vitamin D2 is not sufficient to affect fracture incidence among older people living in institutional care
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
675
5,306,173
Optimum dose of vitamin D for disease prevention in older people: BEST-D trial of vitamin D in primary care
Summary This trial compared the effects of daily treatment with vitamin D or placebo for 1 year on blood tests of vitamin D status . The results demonstrated that daily 4000 IU vitamin D3 is required to achieve blood levels associated with lowest disease risks , and this dose should be tested in future trials for fracture prevention . Introduction The aim of this trial was to assess the effects of daily supplementation with vitamin D3 4000 IU ( 100 μg ) , 2000 IU ( 50 μg ) or placebo for 1 year on biochemical markers of vitamin D status in preparation for a large trial for prevention of fractures and other outcomes . Methods This is a r and omized placebo-controlled trial in 305 community-dwelling people aged 65 years or older in Oxfordshire , UK . Outcomes included biochemical markers of vitamin D status ( plasma 25-hydroxy-vitamin D [ 25[OH]D ] , parathyroid hormone [ PTH ] , calcium and alkaline phosphatase ) , cardiovascular risk factors and tests of physical function . Results Mean ( SD ) plasma 25(OH)D levels were 50 ( 18 ) nmol/L at baseline and increased to 137 ( 39 ) , 102 ( 25 ) and 53 ( 16 ) nmol/L after 12 months in those allocated 4000 IU , 2000 IU or placebo , respectively ( with 88 % , 70 % and 1 % of these groups achieving the pre-specified level of > 90 nmol/L ) . Neither dose of vitamin D3 was associated with significant deviation outside the normal range of PTH or albumin-corrected calcium . The additional effect on 25(OH)D levels of 4000 versus 2000 IU was similar in all subgroups except for body mass index , for which the further increase was smaller in overweight and obese participants compared with normal-weight participants . Supplementation with vitamin D had no significant effects on cardiovascular risk factors or on measures of physical function . Conclusions After accounting for average 70 % compliance in long-term trials , doses of 4000 IU vitamin D3 daily may be required to achieve plasma 25(OH)D levels associated with lowest disease risk in observational studies
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
676
15,040,824
Vitamin D and calcium supplementation prevents osteoporotic fractures in elderly community dwelling residents: a pragmatic population-based 3-year intervention study.
UNLABELLED This study of 9605 community-dwelling residents supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in elderly in a northern European region known to be deficient in vitamin D , especially during winter periods . INTRODUCTION We evaluated the effect of two programs for the prevention of osteoporotic fractures leading to acute hospital admission in a population of elderly community-dwelling residents . MATERIAL S AND METHODS This was a factorial , cluster-r and omized , pragmatic , intervention study . We included 9605 community-dwelling residents aged 66 + years . We offered a prevention program of a daily supplement of 1000 mg of elemental calcium as calcium carbonate and 400 IU ( 10 microg ) of vitamin D3 to a total of 4957 participants . Another program with evaluation and suggestions for the improvement of the domestic environment was offered to a total of 5063 participants . Both programs included revision of the resident 's current pharmaceutical treatment . We achieved information on osteoporotic fractures in the study population from the Danish Hospital Registration Data base . We defined osteoporotic fractures as low energy fractures of the proximal humerus , distal forearm , vertebral column , pelvis , cervical femur , and intertrochanteric femur . RESULTS Active participation was 50.3 % in the Calcium and Vitamin D Program and 46.4 % in the Environmental and Health Program . We observed a 16 % reduction in fracture incidence rate ( relative risk [ RR ] , 0.84 ; CI , 0.72 - 0.98 ; p < 0.025 ) among male and female residents offered the Calcium and Vitamin D Program ( intention-to-prevent analysis ) . CONCLUSIONS This study supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in community-dwelling elderly people in a northern European region known to be deficient in vitamin D , especially during winter periods
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Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
677
24,240,066
Relationship between the effect of eldecalcitol and serum 25(OH)D level
In previous studies , we demonstrated that 12-month treatment with 0.75μg/day eldecalcitol increased bone mineral density in osteoporotic patients regardless of serum 25-hydroxyvitamin D ( 25(OH)D ) level , and in a 3-year r and omized double-blind clinical trial , eldecalcitol significantly reduced the incidences of vertebral and wrist fractures compared to alfacalcidol . However , it remains unclear whether the fracture risk reduction by eldecalcitol is affected by serum 25(OH)D. In the fracture prevention trial , patients with low 25(OH)D level at baseline were supplemented with 400IU/day native vitamin D3 . In the current study , patients from that trial were divided according to the tertiles of serum 25(OH)D level at 6 months after treatment initiation . The increases in lumbar and hip BMD by eldecalcitol were significantly higher in all tertiles than those by alfacalcidol . The incidences of vertebral and osteoporotic fractures tended to be lower in each tertile of the eldecalcitol-treated group than in the corresponding tertile of the alfacalcidol-treated group , with the exception of vertebral fractures in the low tertile . We also investigated whether eldecalcitol treatment affected levels of serum 25(OH)D , serum 1,25(OH)2D , and parathyroid hormone in patients without vitamin D supplementation . With eldecalcitol treatment , serum 1,25(OH)2D concentration was reduced by approximately 50 % , whereas serum levels of parathyroid hormone and 25(OH)D were not affected . The major findings of the present study were that eldecalcitol did not affect serum 25(OH)D levels , and that it reduced the incidence of osteoporotic fractures and increased BMD in comparison with alfacalcidol regardless of serum 25(OH)D level within the range of serum 25(OH)D concentrations at or higher than 20ng/mL. Whether eldecalcitol is similarly effective at vitamin D deficient serum 25(OH)D levels remains to be clarified . This article is part of a Special Issue entitled ' Vitamin D Workshop '
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
678
22,038,523
Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial
Conflicting data regarding cardiovascular effects of thiazolidinediones ( TZDs ) and extra-skeletal effects of vitamin D supported the need for a definitive trial . The Thiazolidinedione Intervention with vitamin D Evaluation ( TIDE ) trial aim ed to assess the effects of TZDs ( rosiglitazone and pioglitazone ) on cardiovascular outcomes and the effects of vitamin D ( cholecalciferol ) on cancers and mortality . A large multicentre 3 × 2 factorial double-blind placebo-controlled r and omised trial recruited from outpatient primary care and specialty clinics in 33 countries . From June 2009 to July 2010 , 1,332 people with type 2 diabetes and other cardiovascular risk factors aged ≥50 years whose HbA1c was 6.5–9.5 % ( 48–80 mmol/mol ) when using two or fewer glucose-lowering drugs were r and omised by a central computer system to placebo ( n = 541 ) , rosiglitazone 4–8 mg/day ( n = 399 ) or pioglitazone 30–45 mg/day ( n = 392 ) ; 1,221 participants were r and omised to placebo ( n = 614 ) or vitamin D 1,000 IU/day ( n = 607 ) . Participants and all study personnel were blind to treatment allocation . The primary outcome for the TZD arm was the composite of myocardial infa rct ion , stroke or cardiovascular death , and for the vitamin D arm it was cancer or all-cause death . All r and omised participants were included in the primary analysis . From the study design , 16,000 people were to be followed for approximately 5.5 years . However , the trial was stopped prematurely because of regulatory concerns after a mean of 162 days without consideration of the accrued data . In the TZD arm , the cardiovascular outcome occurred in five participants ( 0.9 % ) in the placebo groups and three participants ( 0.4 % ) in the TZD groups ( two allocated to pioglitazone , one to rosiglitazone ) . In the vitamin D arm , the primary outcome occurred in three participants ( 0.5 % ) in the placebo group and in two participants ( 0.3 % ) receiving vitamin D. Adverse events were comparable in all groups . Uncertainty persists regarding the clinical ly relevant risks and benefits of TZDs and vitamin D because of the early cancellation of this comprehensive trial . Clinical Trials.gov NCT00879970 The study was funded by GlaxoSmithKline
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
679
18,195,202
Effects of ergocalciferol added to calcium on the risk of falls in elderly high-risk women.
BACKGROUND Ergocalciferol ( vitamin D(2 ) ) supplementation plays a role in fall prevention , but the effect in patients living in the community in sunny climates remains uncertain . We evaluated the effect of ergocalciferol and calcium citrate supplementation compared with calcium alone on the risk of falls in older women at high risk of falling . METHODS A 1-year population -based , double-blind , r and omized controlled trial of 302 community-dwelling ambulant older women aged 70 to 90 years living in Perth , Australia ( latitude , 32 degrees S ) , with a serum 25-hydroxyvitamin D concentration of less than 24.0 ng/mL and a history of falling in the previous year . Participants were r and omized to receive ergocalciferol , 1000 IU/d , or identical placebo ( hereinafter , ergocalciferol and control groups , respectively ) . Both groups received calcium citrate , 1000 mg/d . Fall data were collected every 6 weeks . RESULTS Ergocalciferol therapy reduced the risk of having at least 1 fall over 1 year after adjustment for baseline height , which was significantly different between the 2 groups ( ergocalciferol group , 53.0 % ; control group , 62.9 % ; odds ratio [ OR ] , 0.61 ; 95 % confidence interval [ CI ] , 0.37 - 0.99 ) . When those who fell were grouped by the season of first fall or the number of falls they had , ergocalciferol treatment reduced the risk of having the first fall in winter and spring ( ergocalciferol group , 25.2 % ; control group , 35.8 % ; OR , 0.55 ; 95 % CI , 0.32 - 0.96 ) but not in summer and autumn , and reduced the risk of having 1 fall ( ergocalciferol group , 21.2 % ; control group , 33.8 % ; OR , 0.50 ; 95 % CI , 0.28 - 0.88 ) but not multiple falls . CONCLUSION Patients with a history of falling and vitamin D insufficiency living in sunny climates benefit from ergocalciferol supplementation in addition to calcium , which is associated with a 19 % reduction in the relative risk of falling , mostly in winter
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
680
3,196,245
The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials
Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
681
4,504,582
The Effect of the Modified Eighth Section of Eight-Section Brocade on Osteoporosis in Postmenopausal Women
Abstract Osteoporosis and related fragility fractures represent a serious and global public health problem . To evaluate whether the modified eighth section of Eight-section Brocade ( MESE ) exercise could improve the symptom and indexes associated with osteoporosis in postmenopausal women . Guangzhou and Liuzhou hospital of traditional Chinese medicine in China . Women ( n = 198 ) aged 50 to 75 years were r and omized into Control , Ca , MESE , and MESE + Ca . Subjects in Ca and MESE groups were separately asked to consume thrice daily Calcium Carbonate Chewable D3 tablet and to perform thrice daily MESE exercise by 7 repetitions per time for 12 months . Subjects in MESE + Ca group performed such the combined treatment project for 12 months . Body height and Hospital for Special Surgery ( HSS ) scores of both knees , chronic back pain visual analogue scale scores ( VAS ) , bone mineral density ( BMD ) at L2 to L4 and the left femoral neck , 3-feet Up and Go Test ( 3′ ) and one-leg Stance ( OLS ) . In our study , the improvement in chronic back pain of the patients in Ca , MESE , and MESE + Ca group was better than that in control group . There was 1.9 % and 1.7 % , 2.3 % , and 2.1 % net profit in left femoral neck and lumbar BMD after the treatment for 12 months in MESE and MESE + Ca groups . For the balance capacity , the subjects in MESE and MESE + Ca groups secured much better performance than those in Ca and control group after the treatment for 12 months ( P < 0.001 , P < 0.001 ) . The treatment of MESE exercise is the most effective for the improvement of the symptom and indexes in postmenopausal women . Importantly , the low attrition and the high exercise compliance indicate that MESE exercise is safe , feasible , and well tolerated by postmenopausal women
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
682
6,346,829
Calcium, vitamin D and anabolic steroid in treatment of aged bones: double-blind placebo-controlled long-term clinical trial.
In a double-blind trial , 327 patients ( 57 men ) over 65 ( mean age 79.5 ) years received all possible combinations of calcium carbonate 3 g , vitamin D3 1000 iu , meth and ienone 2.5 mg and /or placebos daily for 9 months . The higher incidence of bone fractures in the placebo group was not significant . Serum calcium , phosphorus , creatinine , aspartate aminotransferase and alkaline phosphatase were followed : the greatest changes occurred with meth and ienone , which thus reduced osteoporotic activity and increased the muscular mass most effectively ; calcium carbonate had the poorest effect . Surprisingly , coronary mortality was higher among those taking all three active substances . With two treatments the increase was not significant , but when both the groups receiving a combination of any two of the treatments were compared with those taking only one or neither of these two treatments , a significant increase in coronary deaths was seen , most significant ( P less than 0.001 ) in those receiving vitamin D3 and meth and ienone
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
683
20,460,620
Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial.
CONTEXT Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures ; however , adherence to daily supplementation is typically poor . OBJECTIVE To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture . DESIGN , SETTING , AND PARTICIPANTS A double-blind , placebo-controlled trial of 2256 community-dwelling women , aged 70 years or older , considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were r and omly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years . The study concluded in 2008 . INTERVENTION 500,000 IU of cholecalciferol or placebo . MAIN OUTCOME MEASURES Falls and fractures were ascertained using monthly calendars ; details were confirmed by telephone interview . Fractures were radiologically confirmed . In a sub study , 137 r and omly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels . RESULTS Women in the cholecalciferol ( vitamin D ) group had 171 fractures vs 135 in the placebo group ; 837 women in the vitamin D group fell 2892 times ( rate , 83.4 per 100 person-years ) while 769 women in the placebo group fell 2512 times ( rate , 72.7 per 100 person-years ; incidence rate ratio [ RR ] , 1.15 ; 95 % confidence interval [ CI ] , 1.02 - 1.30 ; P = .03 ) . The incidence RR for fracture in the vitamin D group was 1.26 ( 95 % CI , 1.00 - 1.59 ; P = .047 ) vs the placebo group ( rates per 100 person-years , 4.9 vitamin D vs 3.9 placebo ) . A temporal pattern was observed in a post hoc analysis of falls . The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months ( test for homogeneity ; P = .02 ) . In the sub study , the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3 % of the sub study participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group , 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L , were approximately 90 nmol/L at 3 months , and remained higher than the placebo group 12 months after dosing . CONCLUSION Among older community-dwelling women , annual oral administration of high-dose cholecalciferol result ed in an increased risk of falls and fractures . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12605000658617 ; is rct n.org Identifier : IS RCT N83409867
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
684
3,951,316
Hip Fractures and Bone Mineral Density in the Elderly—Importance of Serum 25-Hydroxyvitamin D
Background The significance of serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations for hip fracture risk of the elderly is still uncertain . Difficulties reaching both frail and healthy elderly people in r and omized controlled trials or large cohort studies may in part explain discordant findings . We determined hazard ratios for hip fractures of elderly men and women related to serum 25(OH)D , including both the frail and the healthy segment of the elderly population . Methods The AGES-Reykjavik Study is a prospect i ve study of 5764 men and women , age 66–96 years , based on a representative sample of the population of Reykjavik , Icel and . Participation was 71.8 % . Hazard ratios of incident hip fractures and baseline bone mineral density were determined according to serum concentrations of 25(OH)D at baseline . Results Mean follow-up was 5.4 years . Compared with referent values ( 50–75 nmol/L ) , hazard ratios for hip fractures were 2.24 ( 95 % CI 1.63 , 3.09 ) for serum 25(OH)D < 30 nmol/L , adjusting for age , sex , body mass index , height , smoking , alcohol intake and season , and 2.08 ( 95 % CI 1.51 , 2.87 ) , adjusting additionally for physical activity . No difference in risk was associated with 30–50 nmol/L or ≥75 nmol/L in either model compared with referent . Analyzing the sexes separately , hazard ratios were 2.61 ( 95 % CI 1.47 , 4.64 ) in men and 1.93 ( 95 % CI 1.31 , 2.84 ) in women . Values < 30 nmol/L were associated with significantly lower bone mineral density of femoral neck compared with referent , z-scores -0.14 ( 95 % CI −0.27 , −0.00 ) in men and −0.11 ( 95 % CI −0.22 , −0.01 ) in women . Conclusions Our results lend support to the overarching importance of maintaining serum 25(OH)D above 30 nmol/L for bone health of elderly people while potential benefits of having much higher levels could not be detected
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
685
17,716,981
Association between plasma 25-hydroxyvitamin D levels and fracture risk: the EPIC-Oxford study.
The importance of vitamin D for bone health is well established , but few data exist on the relation between plasma levels of 25-hydroxyvitamin D and risk of fracture . The authors examined this association within the EPIC-Oxford ( European Prospect i ve Investigation into Cancer and Nutrition-Oxford cohort ) study of men and women in the United Kingdom ( 1993 - 1999 ) . Five years after recruitment , participants completed a follow-up question naire where fracture incidence was self-reported . Plasma 25-hydroxyvitamin D concentration was measured in 730 incident fracture cases and 1,445 matched controls . There was a clear association between plasma 25-hydroxyvitamin D concentration and month of blood draw , the highest values being during the summer months . Among women , there were significant relations between 25-hydroxyvitamin D levels and age , body mass index , marital status , use of hormone therapy , physical activity , diet group , dietary intake of vitamin D , and alcohol . Similar relations were seen among men , although often they were nonsignificant because of smaller numbers . There was no evidence of an association between plasma 25-hydroxyvitamin D and fracture risk for men or women ; the relative risks associated with a doubling of plasma 25-hydroxyvitamin D were 1.15 ( 95 % confidence interval : 0.82 , 1.61 ) and 0.95 ( 95 % confidence interval : 0.80 , 1.13 ) , respectively . These results were not affected by adjustment for potential confounders and were consistent across a number of subgroups
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
686
24,856,872
Biochemical parameters after cholecalciferol repletion in hemodialysis: results From the VitaDial randomized trial.
BACKGROUND The 2009 KDIGO ( Kidney Disease : Improving Global Outcomes ) chronic kidney disease-mineral and bone disorder clinical practice guideline suggests correcting 25-hydroxyvitamin D3 ( 25[OH]D ) levels<30ng/mL in patients treated with maintenance hemodialysis , but does not provide a specific treatment protocol . STUDY DESIGN 2-center , double-blind , r and omized , 13-week , controlled trial followed by a 26-week open-label study . SETTING & PARTICIPANTS 55 adult maintenance hemodialysis patients with 25(OH)D levels<30ng/mL were recruited from June 2008 through October 2009 . INTERVENTION Cholecalciferol , 25,000IU , per week orally versus placebo for 13 weeks , then 26 weeks of individualized cholecalciferol prescription based on NKF-KDOQI ( National Kidney Foundation-Kidney Disease Outcomes Quality Initiative ) guidelines . OUTCOMES Primary end point was the percentage of patients with 25(OH)D levels≥30ng/mL at 13 weeks . Secondary outcomes included the percentage of patients with normal calcium , phosphorus , and intact parathyroid hormone ( iPTH ) blood levels . Safety measures included incidence of hypercalcemia and hypervitaminosis D. MEASUREMENTS Blood calcium and phosphate were measured weekly ; iPTH , 25(OH)D , 1,25-dihydroxyvitamin D3 ( 1,25[OH]2D ) , and bone turnover markers , trimonthly ; fetuin A and fibroblast growth factor 23 ( FGF-23 ) serum levels and aortic calcification scores were determined at weeks 0 and 39 . RESULTS The primary end point significantly increased in the treatment group compared with the placebo group ( 61.5 % vs 7.4 % ; P<0.001 ) , as well as 1,25(OH)2D levels ( 22.5 [ IQR , 15 - 26 ] vs 11 [ IQR , 10 - 15]pg/mL ; P<0.001 ) and the proportion of patients achieving the target calcium level ( 76.9 % vs 48.2 % ; P=0.03 ) . Incidence of hypercalcemia and phosphate and iPTH levels were similar between groups . The second 26-week study phase did not significantly modify the prevalence of 25(OH)D level≥30ng/mL in patients issued from the placebo group . LIMITATIONS Small size of the study population . CONCLUSIONS Oral weekly administration of 25,000IU of cholecalciferol for 13 weeks is an effective , safe , inexpensive , and manageable way to increase 25(OH)D and 1,25(OH)2D levels in hemodialysis patients . Further evaluation of clinical end points is suggested
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
687
24,849,736
Multivitamin and mineral supplementation is associated with the reduction of fracture risk and hospitalization rate in Chinese adult males: a randomized controlled study
Controversy exists in the literature regarding the efficacy of bone health-related nutrients , especially calcium and vitamin D , in preventing fractures . The aim of our present study was to determine the effect of multivitamin and mineral supplementation on fracture incidence among 3,318 participants from a nutritional intervention trial in Linxian , China . A total of 1,461 men and 1,857 women were enrolled and r and omized to daily supplementation with 26 vitamins and minerals tablet or placebo pills for 6 years , followed by a 16-year post-interventional follow-up . The date s , sites , and causes of the fractures were collected retrospectively via a st and ardized question naire . Cox proportional hazard model was used to estimate hazard ratios and 95 % confidence intervals of fracture incidence in the intervention versus the placebo group . A total of 221 fractures ( 57 in men and 164 in women ) occurred during the entire study period of 21 years and 9 months . In men , the supplement reduced the risk of fracture by 63 % during the trial period , and this protective effect was sustained and statistically significant when analysis included both the trial period and 5- or 10-year post-intervention follow-up ( years 0–11 , P = 0.04 ; years 0–16 , P = 0.02 , respectively ) . The protection against fracture was not apparent > 10 years after cessation of the intervention . In women , no significant effect of supplementation on fracture incidence was seen in any of the study periods . These results demonstrate that a 6-year multivitamin and mineral intervention was associated with significant reduction of fracture risk and fracture-related hospitalization in men , but not in women
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
688
12,609,940
Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial
Abstract Objective : To determine the effect of four monthly vitamin D supplementation on the rate of fractures in men and women aged 65 years and over living in the community . Design : R and omised double blind controlled trial of 100 000 IU oral vitamin D3 ( cholecalciferol ) supplementation or matching placebo every four months over five years . Setting and participants : 2686 people ( 2037 men and 649 women ) aged 65 - 85 years living in the general community , recruited from the British doctors register and a general practice register in Suffolk . Main outcome measures : Fracture incidence and total mortality by cause . Results : After five years 268 men and women had incident fractures , of whom 147 had fractures in common osteoporotic sites ( hip , wrist or forearm , or vertebrae ) . Relative risks in the vitamin D group compared with the placebo group were 0.78 ( 95 % confidence interval 0.61 to 0.99 , P=0.04 ) for any first fracture and 0.67 ( 0.48 to 0.93 , P=0.02 ) for first hip , wrist or forearm , or vertebral fracture . 471 participants died . The relative risk for total mortality in the vitamin D group compared with the placebo group was 0.88 ( 0.74 to 1.06 , P=0.18 ) . Findings were consistent in men and women and in doctors and the general practice population . Conclusion : Four monthly supplementation with 100 000 IU oral vitamin D may prevent fractures without adverse effects in men and women living in the general community . What is already known in this topic Vitamin D and calcium supplements are effective in preventing fractures in elderly women Whether isolated vitamin D supplementation prevents fractures is not clear What this paper adds Four monthly oral supplementation with 100 000 IU vitamin D reduces fractures in men and women aged over 65 living in the general community Total fracture incidence was reduced by 22 % and fractures in major osteoporotic sites by 33
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
689
3,134,427
A randomized controlled trial of vitamin D dosing strategies after acute hip fracture: No advantage of loading doses over daily supplementation
Background There remains uncertainty regarding the appropriate therapeutic management of hip fracture patients . The primary aim of our study was to examine whether large loading doses in addition to daily vitamin D offered any advantage over a simple daily low-dose vitamin D regimen for increasing vitamin D levels . Methods In this r and omized controlled study , patients over age 50 with an acute fragility hip fracture were enrolled from two hospital sites in Ontario , Canada . Participants were r and omized to one of three loading dose groups : placebo ; 50,000 IU vitamin D2 ; or 100,000 IU D2 . Following a placebo/loading dose , all patients received a daily tablet of 1,000 IU vitamin D3 for 90 days . Serum 25-hydroxy vitamin D ( 25-OHD ) was measured at baseline , discharge from acute care ( approximately 4-weeks ) , and 3-months . Results Sixty-five patients were enrolled in the study ( 44 % male ) . An immediate rise in 25-OHD occurred in the 100,000 group , however there were no significant differences in 25-OHD between the placebo , 50,000 and 100,000 loading dose groups after 4-weeks ( 69.3 , 84.5 , 75.6 nmol/L , p = 0.15 ) and 3-months ( 86.7 , 84.2 , 73.3 nmol/L , p = 0.09 ) , respectively . At the end of the study , approximately 75 % of the placebo and 50,000 groups had reached the target therapeutic range ( 75 nmol/L ) , and 44 % of the 100,000 group . Conclusions In correcting vitamin D insufficiency/deficiency in elderly patients with hip fracture , our findings suggest that starting with a lower daily dose of Vitamin D3 achieved similar results as providing an additional large loading dose of Vitamin D2 . At the end of the study , all three groups were equally effective in attaining improvement in 25-OHD levels . Given that a daily dose of 1,000 IU vitamin D3 ( with or without a loading dose ) result ed in at least 25 % of patients having suboptimal vitamin D status , patients with acute hip fracture may benefit from a higher daily dose of vitamin D.Trial registration Clinical Trials #
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
690
15,860,827
Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care
Abstract Objective To assess whether supplementation with calcium and cholecaliferol ( vitamin D3 ) reduces the risk of fracture in women with one or more risk factors for fracture of the hip . Design Pragmatic open r and omised controlled trial . Setting Practice nurse led clinics in primary care . Participants 3314 women aged 70 and over with one or more risk factors for hip fracture : any previous fracture , low body weight ( < 58 kg ) , smoker , family history of hip fracture , or fair or poor self reported health . Intervention Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls , or leaflet only ( control group ) . Main outcome measures Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment , falls , and quality of life ( measured with the SF-12 ) . Results 69 % of the women who completed the follow-up question naire at 24 months were still taking supplements ( 55 % with inclusion of r and omised participants known to be alive ) . After a median follow-up of 25 months ( range 18 to 42 months ) , clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures ( odds ratio for fracture in supplemented group 1.01 , 95 % confidence interval 0.71 to 1.43 ) . The odds ratio for hip fracture was 0.75 ( 0.31 to 1.78 ) . The odds of a woman having a fall at six and 12 months was 0.99 and 0.98 , respectively . Quality of life did not significantly differ between the groups . Conclusion We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture . Registration IS RCT N26118436 , controlled trials registry
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
691
4,982,117
An initial loading-dose vitamin D versus placebo after hip fracture surgery: randomized trial
Background Improving vitamin D ( 25-OHD ) status may be an important modifiable factor that could reduce disability severity , fall-rates and mortality associated after hip fracture surgery . Providing a loading-dose post-surgery may overcome limitations in adherence to daily supplementation . Method In this r and omized , double-blind , placebo-controlled trial , 218 adults , aged 65-years or older , requiring hip fracture surgery were assigned to receive a single loading-dose of cholecalciferol ( 250,000 IU vitamin-D3 , the REVITAHIP - Replenishment of Vitamin D in Hip Fracture strategy ) or placebo , both receiving daily vitamin-D(800 IU ) and calcium ( 500 mg ) for 26-weeks . Outcome measures were 2.4 m gait-velocity , falls , fractures , death ( Week-4 ) , 25-OHD levels , quality -of-life measure ( EuroQoL ) and mortality at weeks-2 , 4 and 26 . Results Mean age of 218 participants was 83.9(7.2 ) years and 77.1 % were women . Baseline mean 25-OHD was 52.7(23.5)nmol/L , with higher levels at Week-2 ( 73 vs 66 nmol/L ; p = .019 ) and Week-4 ( 83 vs 75 nmol/L ; p = .030 ) in the Active-group , but not at Week-26 . At week-4 , there were no differences in 2.4 m gait-velocity ( 0.42 m/s vs 0.39 m/s , p = .490 ) , fractures ( 2.7 % vs 2.8 % , p = .964 ) but Active participants reported less falls ( 6.3 % vs 21.1 % , χ2 = 4.327 ; p = 0.024 ) , with no significant reduction in deaths at week-4 ( 1 vs 3 , p = 0.295 ) , higher percentage reporting ‘ no pain or discomfort ’ ( 96.4 % vs 88.8 % , p = 0.037 ) , and trended for higher EuroQoL-scores ( p = 0.092 ) at week-26 . One case of hypercalcemia at week-2 normalised by week-4 . Conclusion Among older people after hip fracture surgery , the REVITAHIP strategy is a safe and low cost method of improving vitamin-D levels , reducing falls and pain levels . Trial registration The protocol for this study is registered with the Australian New Zeal and Clinical Trials Registry ANZCTRN ACTRN12610000392066 ( Date of registration : 14/05/2010 )
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
692
17,243,866
Two-year randomized controlled trial of vitamin K1 (phylloquinone) and vitamin D3 plus calcium on the bone health of older women.
UNLABELLED Dietary supplementation with vitamin K(1 ) , with vitamin D(3 ) and calcium or their combination , was examined in healthy older women during a 2-year , double-blind , placebo-controlled trial . Combined vitamin K with vitamin D plus calcium was associated with a modest but significant increase in BMC at the ultradistal radius but not at other sites in the hip or radius . INTRODUCTION The putative beneficial role of high dietary vitamin K(1 ) ( phylloquinone ) on BMD and the possibility of interactive benefits with vitamin D were studied in a 2-year double-blind , placebo-controlled trial in healthy Scottish women > or = 60 years of age . MATERIAL S AND METHODS Healthy , nonosteoporotic women ( n = 244 ) were r and omized to receive either ( 1 ) placebo , ( 2 ) 200 microg/day vitamin K(1 ) , ( 3 ) 10 microg ( 400 IU ) vitamin D(3 ) plus 1000 mg calcium/day , or ( 4 ) combined vitamins K(1 ) and D(3 ) plus calcium . Baseline and 6-month measurements included DXA bone mineral scans of the hip and wrist , markers of bone turnover , and vitamin status . Supplementation effects were tested using multivariate general linear modeling , with full adjustment for baseline and potential confounding variables . RESULTS Significant bone mineral loss was seen only at the mid-distal radius but with no significant difference between groups . However , women who took combined vitamin K and vitamin D plus calcium showed a significant and sustained increase in both BMD and BMC at the site of the ultradistal radius . Serum status indicators responded significantly to respective supplementation with vitamins K and D. Over 2 years , serum vitamin K(1 ) increased by 157 % ( p < 0.001 ) , the percentage of undercarboxylated osteocalcin ( % GluOC ) decreased by 51 % ( p < 0.001 ) , serum 25-hydroxyvitamin D [ 25(OH)D ] increased by 17 % ( p < 0.001 ) , and PTH decreased by 11 % ( p = 0.049 ) . CONCLUSIONS These results provide evidence of a modest synergy in healthy older women from nutritionally relevant intakes of vitamin K(1 ) together with supplements of calcium plus moderate vitamin D(3 ) to enhance BMC at the ultradistal radius , a site consisting of principally trabecular bone . The substantial increase in gamma-carboxylation of osteocalcin by vitamin K may have long-term benefits and is potentially achievable by increased dietary intakes of vitamin K rather than by supplementation
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
693
28,350,929
Effect of Vitamin D and Calcium Supplementation on Cancer Incidence in Older Women: A Randomized Clinical Trial
Importance Evidence suggests that low vitamin D status may increase the risk of cancer . Objective To determine if dietary supplementation with vitamin D3 and calcium reduces the risk of cancer among older women . Design , Setting , and Participants A 4-year , double-blind , placebo-controlled , population -based r and omized clinical trial in 31 rural counties ( June 24 , 2009 , to August 26 , 2015—the final date of follow-up ) . A total of 2303 healthy postmenopausal women 55 years or older were r and omized , 1156 to the treatment group and 1147 to the placebo group . Duration of treatment was 4 years . Interventions The treatment group ( vitamin D3 + calcium group ) received 2000 IU/d of vitamin D3 and 1500 mg/d of calcium ; the placebo group received identical placebos . Main Outcomes and Measures The primary outcome was the incidence of all-type cancer ( excluding nonmelanoma skin cancers ) , which was evaluated using Kaplan-Meier survival analysis and proportional hazards modeling . Results Among 2303 r and omized women ( mean age , 65.2 years [ SD , 7.0 ] ; mean baseline serum 25-hydroxyvitamin D level , 32.8 ng/mL [ SD , 10.5 ] ) , 2064 ( 90 % ) completed the study . At year 1 , serum 25-hydroxyvitamin D levels were 43.9 ng/mL in the vitamin D3 + calcium group and 31.6 ng/mL in the placebo group . A new diagnosis of cancer was confirmed in 109 participants , 45 ( 3.89 % ) in the vitamin D3 + calcium group and 64 ( 5.58 % ) in the placebo group ( difference , 1.69 % [ 95 % CI , −0.06 % to 3.46 % ] ; P = .06 ) . Kaplan-Meier incidence over 4 years was 0.042 ( 95 % CI , 0.032 to 0.056 ) in the vitamin D3 + calcium group and 0.060 ( 95 % CI , 0.048 to 0.076 ) in the placebo group ; P = .06 . In unadjusted Cox proportional hazards regression , the hazard ratio was 0.70 ( 95 % CI , 0.47 to 1.02 ) . Adverse events potentially related to the study included renal calculi ( 16 participants in the vitamin D3 + calcium group and 10 in the placebo group ) , and elevated serum calcium levels ( 6 in the vitamin D3 + calcium group and 2 in the placebo group ) . Conclusions and Relevance Among healthy postmenopausal older women with a mean baseline serum 25-hydroxyvitamin D level of 32.8 ng/mL , supplementation with vitamin D3 and calcium compared with placebo did not result in a significantly lower risk of all-type cancer at 4 years . Further research is necessary to assess the possible role of vitamin D in cancer prevention . Trial Registration clinical trials.gov Identifier :
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
694
20,458,090
Effect of high-dosage cholecalciferol and extended physiotherapy on complications after hip fracture: a randomized controlled trial.
BACKGROUND Care of elderly patients after hip fracture is not well established . METHODS We enrolled 173 patients with acute hip fracture who were 65 years or older ( 79.2 % women ; mean age , 84 years ; 77.4 % living at home ) . Using a factorial design , we r and omly allocated patients to extended physiotherapy ( PT ) ( supervised 60 min/d during acute care plus an unsupervised home program ) vs st and ard PT ( supervised 30 min/d during acute care plus no home program ; single-blinded ) , and to cholecalciferol therapy , 2000 vs 800 IU/d ( double-blinded ) . Primary outcome was rate of falls ; secondary outcome was rate of hospital readmissions during the 12-month follow-up . All analyses included 173 individuals and used multivariate Poisson regression analyses . RESULTS At baseline , 50.9 % of participants had 25-hydroxyvitamin D levels of less than 12 ng/mL and 97.7 % of less than 30 ng/mL. We documented 212 falls and 74 hospital readmissions . Because this was a factorial design trial , all analyses tested the main effect of each treatment while controlling for the other in 173 participants . Extended vs st and ard PT reduced the rate of falls by 25 % ( 95 % confidence interval [ CI ] , -44 % to -1 % ) . Cholecalciferol treatment , 2000 vs 800 IU/d , did not reduce falls ( 28 % ; 95 % CI , -4 % to 68 % ) , but reduced the rate of hospital readmissions by 39 % ( 95 % CI , -62 % to -1 % ) . CONCLUSIONS Extended PT was successful in reducing falls but not hospital readmissions , whereas cholecalciferol treatment , 2000 IU/d , was successful in reducing hospital readmission but not falls . Thus , the 2 strategies may be useful together because they address 2 different and important complications after hip fracture
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
695
10,999,778
Effect of calcium or 25OH vitamin D3 dietary supplementation on bone loss at the hip in men and women over the age of 60.
Dietary supplements that prevent bone loss at the hip and that can be applied safely in the elderly are likely to reduce hip fractures . A daily dietary supplement of 750 mg calcium or 15 microg 25OH vitamin D3 on bone loss at the hip and other sites , bone turnover and calcium-regulating hormones were studied over 4 yr in elderly volunteers using a r and omized , double-blind , placebo-controlled trial . Bone mineral density ( BMD ) was measured by dual x-ray absorptiometry and bone structure by radiographs . Calcium biochemistry and bone turnover markers were measured in blood and urine . The 316 women entering the trial had a mean age of 73.7 yr and the 122 men of 75.9 yr . Baseline median calcium intake was 546 mg/day , and median serum 25OH vitamin D3 was 59 nmol/L. On placebo , loss of BMD at total hip was 2 % and femoral medulla expansion was 3 % over 4 yr . Calcium reduced bone loss , secondary hyperparathyroidism , and bone turnover . 25OH vitamin D3 was intermediate between placebo and calcium . Fracture rates and drop-out rates were similar among groups , and there were no serious adverse events with either supplement . A calcium supplement of 750 mg/day prevents loss of BMD , reduces femoral medullary expansion , secondary hyperparathyroidism , and high bone turnover . A supplement of 15 microg/day 25OH vitamin D3 is less effective , and because its effects are seen only at low calcium intakes , suggests that its beneficial effect is to reverse calcium insufficiency
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
696
20,305,368
Muscle strength and mobility in vitamin D-insufficient female geriatric patients: a randomized controlled trial on vitamin D and calcium supplementation
Background and aims : Insufficient vitamin D status , commonly found in older people , has been associated with muscle weakness which , in old age , impairs mobility and is a risk factor for falling . In a r and omized , double-blind placebo-controlled trial , we tested the hypothesis that vitamin D + calcium supplementation improves muscle strength and mobility , compared with calcium mono-therapy in vitamin D-insufficient female geriatric patients . Methods : Seventy female geriatric patients > 65 years of age with serum 25-hydroxyvitamin D3 ( 25OHD ) concentrations between 20 and 50 nmol/L , visiting an outpatient geriatric department , were included . Participants received either cholecalciferol 400 IU/day + calcium 500 mg/day ( D/Cal group ) or a placebo + calcium 500 mg/day ( Plac/Cal group ) for 6 months . At baseline and 6 months , muscle strength , power and functional mobility were tested . Results : At baseline , 25OHD was significantly ( p<0.05 ) associated with knee extension strength ( r=0.42 ) , h and grip strength ( r=0.28 ) , leg extension power ( r=0.34 ) , Timed Get Up and Go ( r=−0.31 ) and Modified Cooper test ( r=0.44 ) . At 6 months , a significant difference in 25OHD ( 77.2 vs 41.6 nmol/L , p<0.001 ) and 1,25OHD was found between the two groups . Significantly improving vitamin D status in the D/Cal group compared with the Plac/Cal group did not result in a significant difference in strength or functional mobility between the two groups . Conclusions : Daily 400IU vitamin D + 500 mg calcium supplementation is not enough to significantly improve strength or mobility in vitamin D-insufficient female geriatric patients
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
697
16,481,635
Calcium plus vitamin D supplementation and the risk of fractures.
BACKGROUND The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal . METHODS We recruited 36,282 postmenopausal women , 50 to 79 years of age , who were already enrolled in a Women 's Health Initiative ( WHI ) clinical trial . We r and omly assigned participants to receive 1000 mg of elemental [ corrected ] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo . Fractures were ascertained for an average follow-up period of 7.0 years . Bone density was measured at three WHI centers . RESULTS Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group ( P<0.01 ) . Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture ( 95 percent confidence interval , 0.72 to 1.08 ) , 0.90 for clinical spine fracture ( 0.74 to 1.10 ) , and 0.96 for total fractures ( 0.91 to 1.02 ) . The risk of renal calculi increased with calcium plus vitamin D ( hazard ratio , 1.17 ; 95 percent confidence interval , 1.02 to 1.34 ) . Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 ( 95 percent confidence interval , 0.52 to 0.97 ) . Effects did not vary significantly according to prer and omization serum vitamin D levels . CONCLUSIONS Among healthy postmenopausal women , calcium with vitamin D supplementation result ed in a small but significant improvement in hip bone density , did not significantly reduce hip fracture , and increased the risk of kidney stones . ( Clinical Trials.gov number , NCT00000611 . )
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
698
23,939,263
Cholecalciferol treatment to reduce blood pressure in older patients with isolated systolic hypertension: the VitDISH randomized controlled trial.
IMPORTANCE Observational data link low 25-hydroxyvitamin D levels to both prevalent blood pressure and incident hypertension . No clinical trial has yet examined the effect of vitamin D supplementation in isolated systolic hypertension , the most common pattern of hypertension in older people . OBJECTIVE To test whether high-dose , intermittent cholecalciferol supplementation lowers blood pressure in older patients with isolated systolic hypertension . DESIGN Parallel group , double-blind , placebo-controlled r and omized trial . SETTING Primary care clinics and hospital clinics . PARTICIPANTS Patients 70 years and older with isolated systolic hypertension ( supine systolic blood pressure > 140 mm Hg and supine diastolic blood pressure < 90 mm Hg ) and baseline 25-hydroxyvitamin D levels less than 30 ng/mL were r and omized into the trial from June 1 , 2009 , through May 31 , 2011 . INTERVENTIONS A total of 100,000 U of oral cholecalciferol or matching placebo every 3 months for 1 year . MAIN OUTCOMES AND MEASURES Difference in office blood pressure , 24-hour blood pressure , arterial stiffness , endothelial function , cholesterol level , insulin resistance , and b-type natriuretic peptide level during 12 months . RESULTS A total of 159 participants were r and omized ( mean age , 77 years ) . Mean baseline office systolic blood pressure was 163/78 mm Hg . Mean baseline 25-hydroxyvitamin D level was 18 ng/mL. 25-Hydroxyvitamin D levels increased in the treatment group compared with the placebo group ( + 8 ng/mL at 1 year , P < .001 ) . No significant treatment effect was seen for mean ( 95 % CI ) office blood pressure ( −1 [ −6 to 4]/−2 [ −4 to 1 ] mm Hg at 3 months and 1 [ −2 to 4]/0 [ −2 to 2 ] mm Hg overall treatment effect ) . No significant treatment effect was evident for any of the secondary outcomes ( 24-hour blood pressure , arterial stiffness , endothelial function , cholesterol level , glucose level , and walking distance ) . There was no excess of adverse events in the treatment group , and the total number of falls was nonsignificantly lower in the group receiving vitamin D ( 36 vs 46 , P = .24 ) . CONCLUSIONS AND RELEVANCE Vitamin D supplementation did not improve blood pressure or markers of vascular health in older patients with isolated systolic hypertension . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N92186858
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
37
31,860,103
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .
699
21,956,713
Effects of three-monthly oral 150,000 IU cholecalciferol supplementation on falls, mobility, and muscle strength in older postmenopausal women: a randomized controlled trial.
Daily vitamin D in addition to calcium supplementation reduces falls and fractures in older women . However , poor adherence to therapy is a common clinical problem . To examine the effects of supervised oral 3-monthly vitamin D therapy on falls , muscle strength , and mobility , we conducted a 9-month r and omized , double-blind , placebo-controlled trial in 686 community-dwelling ambulant women aged over 70 years . Participants received either oral cholecalciferol 150,000 IU every 3 months ( n = 353 ) or an identical placebo ( n = 333 ) . All participants were advised to increase dietary calcium intake . Falls data were collected 3-monthly . At baseline , 3 , 6 , and 9 months , muscle strength was measured by a h and held dynamometer and mobility by the Timed Up and Go ( TUG ) test . Serum 25 hydroxyvitamin D ( 25OHD ) was measured in a subgroup of 40 subjects . Mean age at baseline was 76.7 ± 4.1 years . The average serum 25OHD value at baseline was 65.8 ± 22.7 nmol/L. By 3 , 6 , and 9 months after supplementation , 25OHD levels of the vitamin D group were approximately 15 nmol/L higher than the placebo group . Calcium intake did not change significantly between baseline ( 864 ± 412 mg/day ) and 9 months ( 855 ± 357 mg/day ) . Faller rates in the two groups did not differ : vitamin D group , 102 of 353 ( 29 % ) ; placebo group , 89 of 333 ( 27 % ) . At 9 months , compared to placebo or baseline , muscle strength , and TUG were not altered by vitamin D. In conclusion , oral cholecalciferol 150,000 IU therapy administered 3-monthly had neither beneficial nor adverse effects on falls or physical function . These data together with previous findings confirm that intermittent large doses of vitamin D are ineffective or have a deleterious effect on falls . Thus despite adherence issues with daily vitamin D replacement , an intermittent , high-dose vitamin D regimen can not be supported as a strategy to reduce falls and fractures
37
Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy
Importance Vitamin D and calcium supplements are recommended for the prevention of fracture , but previous r and omized clinical trials ( RCTs ) have reported conflicting results , with uncertainty about optimal doses and regimens for supplementation and their overall effectiveness . Objective To assess the risks of fracture associated with differences in concentrations of 25-hydroxyvitamin D ( 25[OH]D ) in observational studies and the risks of fracture associated with supplementation with vitamin D alone or in combination with calcium in RCTs .