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Glucosamine Sulfate decreases progression of knee osteoarthritis in along-term, randomised, placebo-controlled, independent, confirmatory trial.


Karel Pavelka: 1, Jindriska Gatterova: 1, Marta Olejarova: 1, Stanislav Machacek: 1, Giampaolo Giacovelli: 2 and Lucio C.Rovati: 1

1.Institute of Rheumatology,Prague,12850,Czech Republic.

2.Rotta Research Laboratories, Monza, Milan, 20052, Italy.

Background: Glucosamine sulfate was proposed to improve knee osteoarthritis (OA)symptoms and to prevent radiological mean joint space narrowing (JSN), as assessed by digital image analysis, over 3 years [Arthritis Rheum 1999;42(suppl):1975 ]. This independent study was conducted to confirm and extend those results by slightly different techniques.

Methods: 202 patients with knee OA diagnosed according to the ACR criteria were randomised to double-blind treatment with oral glucosamine sulfate 1500 mg once-a-day, or placebo for 3 years. The minimum joint space width (JSW)of the narrowest medial compartment of the tibio-femoral joint was measured visually by a 0.1 mm graduated magnifying glass, on standardised weight-bearing antero-posterior radiographs of each knee in full extension.Symptoms were assessed by both the WOMAC (LK 3.0 version) and the Lequesne indices.Final changes from enrollment (JSN or D) were analysed by a worst case scenario intention-to-treat (ITT), assigning to missing values the final average change observed with placebo.

Results: The two groups were comparable for demographic and disease characteristics. The 3-year JSN observed with placebo was approximately 0.2 mm and significantly higher than with glucosamine sulfate, for which no JSN occurred in average. Symptoms improved in both groups, but significantly more with glucosamine sulfate.

  Placebo
Sulfate (N=101)
Glucosamine Sulfate
Sulfate (N=101)
JSW enrolment (mm)  3.59 (0.16)  3.97 (0.14)
JSN 3 years (mm) -0.19 (0.05) +0.02 (0.05)**
Lequesne enrolment (points)  8.9 (0.2)  9.0 (0.2)
D Lequesne 3 years (points) -0.8 (0.2) -1.7 (0.2)**
WOMAC enrolment (points)  30.5 (1.4)  30.7 (1.4)
D WOMAC 3 years (points) -4.9 (0.8) -8.0 (0.9)*

Data are mean (SE).*p=0.010 and **p=0.002 vs.placebo (ANOVA).



Slightly more patients left the study prematurely with placebo than with glucosamine sulfate (total 46% vs. 35%,with 10% vs. 8%for adverse events,respectively): results on per-protocol completers were even slightly more favorable to glucosamine sulfate, but with a similar degree of significance than in ITT.

Conclusions:

This study confirmed that the natural JSN in knee OA is slow (<0.1 mm/year in average), but can be prevented by glucosamine sulfate that also induces a significant symptom.