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Efficacy of glucosamine sulfate in knee osteoarthritis : a randomized controlled discontinuation trial Cibere, Jolanda

Abstract

Objectives: The primary objective of this study was to determine the clinical efficacy of glucosamine in knee OA in a randomized discontinuation trial. As a secondary objective, the effect of glucosamine on cartilage type II collagen degradation (CII) was evaluated. Methods: A multicenter 24-week randomized double-blind placebo-controlled glucosamine sulfate (GS) discontinuation trial was conducted. Subjects were included if they met the American College of Rheumatology criteria for knee OA, had osteophytes on x-ray, were current users of glucosamine, and had had at least moderate relief of knee pain after starting glucosamine. Subjects received GS at the same dose as prior to the study or placebo (PL) at an equivalent dose. Treatment was continued for 24 weeks or until disease flare. The primary outcome was the proportion of subjects with disease flare in the two groups. Secondary outcomes included time to flare, severity of flare, Western Ontario and McMaster Universities OA index (WOMAC) scores, analgesic medication use and CII degradation markers. Results: The intent-to-treat analysis included 137 subjects (71 GS, 66 PL), aged 40-88 yrs (mean 64) with median baseline WOMAC pain on walking of 13mm (range 0-78mm) and median duration of GS use of 1.5 yrs (range 0 . 1 - 7 yrs). The proportion of subjects who developed a flare in the PL and GS groups was 42% and 45%, respectively (95% confidence interval [CI], -19%, 14%; p=0.76). After adjustment for sex and OA radiographic severity at baseline, the risk of disease flare was similar in the two groups (Cox regression hazard ratio for GS group 0.81; 95% CI 0.47, 1.40; p=0.45). Similarly, no significant differences were seen between treatment groups in the severity of flare, WOMAC scores, analgesic medication use and CII degradation markers. Conclusion: In knee OA subjects with moderate to marked subjective improvement with prior glucosamine use, this study provides no evidence of benefit from the continued use of glucosamine sulfate over 6 months. No statistically significant effect of glucosamine sulfate on type II collagen degradation was demonstrated.

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