| Summary: | 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. === Medicine, Faculty of === Population and Public Health (SPPH), School of === Graduate
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