TY - JOUR
T1 - Comparing two low-energy diets for the treatment of knee osteoarthritis symptoms in obese patients: a pragmatic randomized clinical trial
AU - Riecke, Birgit Falk
AU - Christensen, R
AU - Christensen, Pia
AU - Leeds, A R
AU - Boesen, M
AU - Lohmander, L S
AU - Astrup, A
AU - Bliddal, H
N1 - Copyright 2010 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
PY - 2010/6/1
Y1 - 2010/6/1
N2 - 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)>30kg/m2]; >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/day, 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 (ITT) 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) 6.4; 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 11.1 (95%CI 13.6, 8.5) in the combined groups. At week 16 weight loss in the combined groups was 12.8. 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/day 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.ClinicalTrials.
AB - 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)>30kg/m2]; >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/day, 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 (ITT) 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) 6.4; 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 11.1 (95%CI 13.6, 8.5) in the combined groups. At week 16 weight loss in the combined groups was 12.8. 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/day 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.ClinicalTrials.
U2 - http://dx.doi.org/10.1016/j.joca.2010.02.012
DO - http://dx.doi.org/10.1016/j.joca.2010.02.012
M3 - Journal article
SN - 1063-4584
VL - 18
SP - 746
EP - 754
JO - Osteoarthritis and Cartilage
JF - Osteoarthritis and Cartilage
IS - 6
ER -