PMID:
     20206314
Authors:
     Riecke BF, Christensen R, Christensen P, Leeds AR, Boesen M, Lohmander LS,
     Astrup A, Bliddal H.
Title:
     Comparing two low-energy diets for the treatment of knee osteoarthritis symptoms 
     in obese patients: a pragmatic randomized clinical trial.
Journal:
     Osteoarthritis Cartilage. 2010 Jun;18(6):746-54. doi: 10.1016/j.joca.2010.02.012. 
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/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 > or =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.

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