A Large, Randomized, Placebo Controlled, Double-Blind Study
of Glucosamine Sulfate vs Piroxicam and vs Their Association,
on the Kinetics of the Symptomatic Effect in Knee Osteoarthritis

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:    Frankp@chiro.org

FROM: Osteoarthritis and Cartilage 1994;   2 (Suppl 1)

Rovati LC, Giacovelli G, Annefeld M, Dreiser RL, Avouac B

Second International Congress of the
Osteoarthritis Research Society.
Orlando, Florida December 9-11, 1994

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METHODS:   329 patients (245 women, 84 men; median age 67 years) were enrolled in this multicentre study and randomized in 4 homogenous groups. The following once-a-day oral treatments were given for 90 days: 1) 1500 mg glucosamine sulfate (GS); 2) 20 mg piroxicam (Pir); 3) their association (GS+Pir); 4) placebo (Plac). Patients were then followed-up for further 60 days without treatment. The main efficacy variable was represented by the Lequesne index.

RESULTS:   Analysis of variance for repeated measures was performed according to an intention to treat approach (last value carried forward) on the 310 evaluable patients, including drop-outs for inefficacy, worsening, or concomitant use of other symptomatic drugs. There were significant (p=0.0001) treatment effects, time effects and treatment time interactions. Adverse events during treatment were present in 19 patients with Plac (i.e. 24.4%, yielding 3 drop-outs: d-o), 12 with GS (14.8%, no d-o), 36 with Pir (40.9%, 20 d-o) and 28 with the association (35.9%, 3 d-o): p=0.0001.

CONCLUSION:   GS was confirmed an effective and well tolerated Symptomatic Slow Acting Drug in OA, with a steadily increasing effect, persisting after drug withdrawal. Pir was less tolerated, had a similar efficacy at the beginning of treatment, but that wore off at withdrawal.

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