title: Comparing two low-energy diets for the treatment of knee osteoarthritis symptoms in obese patients: a pragmatic randomized clinical trial.
abstract: OBJECTIVE
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: The Parker Institute, Frederiksberg Hospital, Denmark.
authors.forename: B F
authors.initials: BF
authors.lastname: Riecke
authors.forename: R
authors.initials: R
authors.lastname: Christensen
authors.forename: P
authors.initials: P
authors.lastname: Christensen
authors.forename: A R
authors.initials: AR
authors.lastname: Leeds
authors.forename: M
authors.initials: M
authors.lastname: Boesen
authors.forename: L S
authors.initials: LS
authors.lastname: Lohmander
authors.forename: A
authors.initials: A
authors.lastname: Astrup
authors.forename: H
authors.initials: H
authors.lastname: Bliddal
mesh_terms: D000368:Aged; D015992:Body Mass Index; D001835:Body Weight; D004038:Diet, Reducing / Q000379:methods*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications* / Q000178:diet therapy*; D020370:Osteoarthritis, Knee / Q000178:diet therapy* / Q000503:physiopathology; D010147:Pain Measurement; D011446:Prospective Studies; D012720:Severity of Illness Index