Advanced

Comparing two low-energy diets for the treatment of knee osteoarthritis symptoms in obese patients: a pragmatic randomized clinical trial

Riecke, B. F.; Christensen, R.; Christensen, P.; Leeds, A. R.; Boesen, M.; Lohmander, Stefan LU ; Astrup, A. and Bliddal, H. (2010) In Osteoarthritis and Cartilage 18(6). p.746-754
Abstract
Objectives To evaluate in a prospective, randomized clinical trial (RCT), symptom response among obese knee osteoarthritis (OA) patients following a feasible. intensive weight-loss program for 16 weeks Methods Eligible patients were obese [body mass index (BMI)> 30 kg/m(2)], >50 years old, with primary knee OA Participants were randomized to either a very-low-energy diet (VLED) or a low-energy diet (LED) (415 kcal/day and 810 kcal/clay, respectively), using commercially available formula foods only for the first 8 weeks, managed by dieticians The 8 weeks were followed by an additional 8-week period of a hypo-energetic diet consisting of normal food plus meal replacements (1200 kcal/day) The primary endpoint was the number of patients... (More)
Objectives To evaluate in a prospective, randomized clinical trial (RCT), symptom response among obese knee osteoarthritis (OA) patients following a feasible. intensive weight-loss program for 16 weeks Methods Eligible patients were obese [body mass index (BMI)> 30 kg/m(2)], >50 years old, with primary knee OA Participants were randomized to either a very-low-energy diet (VLED) or a low-energy diet (LED) (415 kcal/day and 810 kcal/clay, respectively), using commercially available formula foods only for the first 8 weeks, managed by dieticians The 8 weeks were followed by an additional 8-week period of a hypo-energetic diet consisting of normal food plus meal replacements (1200 kcal/day) The primary endpoint was the number of patients responding according to the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) responder criterion The statistical analysis was based on a non-responder intention-to-treat gro population (baseline observation carried forward) Results One hundred and ninety two patients (155 (80 7%) females) with a mean age 62 5 years [standard deviation (SD) 64, range 50-78 years), average BMI 37.3 (SD 4 8) were included At 16 weeks, similar proportions of the VLED and LED groups, 59 (61 5%). and 63 (65.6%) patients, respectively, met the OMERACT-OARSI responder criteria, with no statistical significant difference between the groups (P=0 55) Combining the groups the pooled estimate was 64% meeting the responder criteria [95% confidence interval (CI) 57%. 70%] There was an overall reduction in pain, corresponding to an average pain reduction on the visual analogue scale (VAS) of 111 (95%CI 13 6, 8 5) in the combined groups At week 16 weight loss in the combined groups was 128 kg (95%CI 11 84-13 66, P < 0 001) 71% lost >= 10% body weight in both diet groups, with a pooled estimate of 74% (95%CI 68-80%) Conclusion No clinically significant differences were found between the 415 kcal/day and 810 kcal/clay diets A 16-week formula-diet weight-loss program resulted in a fast and effective weight loss with very few adverse events resulting in a highly significant improvement in symptoms in overweight patients with knee OA ChnicalTrials gov Identifier NCT00655941 (C) 2010 Osteoarthritis Research Society International Published by Elsevier Ltd All rights reserved (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Randomized clinical trial, Diet, Knee osteoarthritis, Weight-loss
in
Osteoarthritis and Cartilage
volume
18
issue
6
pages
746 - 754
publisher
Elsevier
external identifiers
  • wos:000278642400003
  • scopus:77952881699
ISSN
1063-4584
DOI
10.1016/j.joca.2010.02.012
language
English
LU publication?
yes
id
118f7176-6f5c-4c29-b383-498e91900d52 (old id 1630854)
date added to LUP
2010-07-21 13:56:42
date last changed
2018-07-01 03:02:38
@article{118f7176-6f5c-4c29-b383-498e91900d52,
  abstract     = {Objectives To evaluate in a prospective, randomized clinical trial (RCT), symptom response among obese knee osteoarthritis (OA) patients following a feasible. intensive weight-loss program for 16 weeks Methods Eligible patients were obese [body mass index (BMI)&gt; 30 kg/m(2)], &gt;50 years old, with primary knee OA Participants were randomized to either a very-low-energy diet (VLED) or a low-energy diet (LED) (415 kcal/day and 810 kcal/clay, respectively), using commercially available formula foods only for the first 8 weeks, managed by dieticians The 8 weeks were followed by an additional 8-week period of a hypo-energetic diet consisting of normal food plus meal replacements (1200 kcal/day) The primary endpoint was the number of patients responding according to the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) responder criterion The statistical analysis was based on a non-responder intention-to-treat gro population (baseline observation carried forward) Results One hundred and ninety two patients (155 (80 7%) females) with a mean age 62 5 years [standard deviation (SD) 64, range 50-78 years), average BMI 37.3 (SD 4 8) were included At 16 weeks, similar proportions of the VLED and LED groups, 59 (61 5%). and 63 (65.6%) patients, respectively, met the OMERACT-OARSI responder criteria, with no statistical significant difference between the groups (P=0 55) Combining the groups the pooled estimate was 64% meeting the responder criteria [95% confidence interval (CI) 57%. 70%] There was an overall reduction in pain, corresponding to an average pain reduction on the visual analogue scale (VAS) of 111 (95%CI 13 6, 8 5) in the combined groups At week 16 weight loss in the combined groups was 128 kg (95%CI 11 84-13 66, P &lt; 0 001) 71% lost &gt;= 10% body weight in both diet groups, with a pooled estimate of 74% (95%CI 68-80%) Conclusion No clinically significant differences were found between the 415 kcal/day and 810 kcal/clay diets A 16-week formula-diet weight-loss program resulted in a fast and effective weight loss with very few adverse events resulting in a highly significant improvement in symptoms in overweight patients with knee OA ChnicalTrials gov Identifier NCT00655941 (C) 2010 Osteoarthritis Research Society International Published by Elsevier Ltd All rights reserved},
  author       = {Riecke, B. F. and Christensen, R. and Christensen, P. and Leeds, A. R. and Boesen, M. and Lohmander, Stefan and Astrup, A. and Bliddal, H.},
  issn         = {1063-4584},
  keyword      = {Randomized clinical trial,Diet,Knee osteoarthritis,Weight-loss},
  language     = {eng},
  number       = {6},
  pages        = {746--754},
  publisher    = {Elsevier},
  series       = {Osteoarthritis and Cartilage},
  title        = {Comparing two low-energy diets for the treatment of knee osteoarthritis symptoms in obese patients: a pragmatic randomized clinical trial},
  url          = {http://dx.doi.org/10.1016/j.joca.2010.02.012},
  volume       = {18},
  year         = {2010},
}