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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 orcid ; 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)
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author
; ; ; ; ; ; and
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
  • pmid:20206314
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
2016-04-01 09:54:41
date last changed
2023-01-01 23:15:13
@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}},
  keywords     = {{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}},
  doi          = {{10.1016/j.joca.2010.02.012}},
  volume       = {{18}},
  year         = {{2010}},
}