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Prevention of knee osteoarthritis in overweight females: the first preventive randomized controlled trial in osteoarthritis [with consumer summary] |
Runhaar J, van Middelkoop M, Reijman M, Willemsen S, Oei EH, Vroegindeweij D, van Osch G, Koes B, Bierma-Zeinstra SMA |
The American Journal of Medicine 2015 Aug;128(8):888-895 |
clinical trial |
10/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: Yes; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: With accumulating knowledge on osteoarthritis development, the next step is to focus on possibilities for primary prevention. METHODS: In a 2x2 factorial design, the effects of a diet-and-exercise program and of oral glucosamine sulfate (double blind and placebo-controlled) on the incidence of knee osteoarthritis were evaluated in a high-risk group of 407 middle-aged women with a body mass index > 27 kg/m2 without clinical signs of knee osteoarthritis at baseline (ISRCTN42823086). Primary outcome was the incidence of knee osteoarthritis, defined as Kellgren AND Lawrence grade > 2, joint space narrowing of > 1.0 mm, or clinical knee osteoarthritis (clinical and radiographic American College of Rheumatology criteria) after 2.5 years. RESULTS: After 2.5 years, only 10% of all subjects were lost to follow-up, and 17% of all knees showed incident knee osteoarthritis. Accounting for the significant interaction between the interventions, no significant main effect of either intervention was found. Independently, both interventions alone showed indications of reduced knee osteoarthritis incidence (odds ratio (OR) 0.69; 95% CI 0.39 to 1.21 for the diet-and-exercise program and OR 0.60; 95% CI 0.31 to 1.12 for the glucosamine intervention). These effects were neutralized in subjects receiving both interventions (OR 0.97; 95% CI 0.55 to 1.71). CONCLUSIONS: No significant main effects of the diet-and-exercise program and of glucosamine sulfate were found on incident knee osteoarthritis. Nevertheless, this trial provides valuable insights for future trial design for preventive osteoarthritis studies.
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