European Jrnl of Clin Pharmacology 1996; 50 (6): 542
Forster KK, Schmid K, Rovati LC, Giacovelli G, Dreiser RL, Bourgeois P, Avouac B
The objective of this prospective, randomized, placebo-controlled, and double-blind (''double-dummy'') clinical multicentre study was to compare the symptomatic efficacy of glucosamine sulfate (GS; 1500 mg per day) with that of piroxicam (Pir; 20 mg/day) and with that of their combination (1500 mg GS + 20 mg Pir/day) over 90 days of treatment and over 60 days of post-treatment observation in patients with mild to moderate osteoarthritis (OA) of the knee.
329 patients with OA of the knee were recruited for the study according to defined inclusion and exclusion criteria and randomly assigned to one of four treatment groups: 81 patients were treated with GS, 88 with Pir, 80 with the combination, and 80 patients with placebo. Symptomatic status was followed and assessed by a questionnaire concerning pain and joint movability during daily activities (LI; index of severity for OA of the knee; Lequesne 1987).
At the end of the treatment phase (day 90) there was a LI reduction of 48.3% in the GS, of 37.9% in the Pir, of 46.3% in the combination, and of 13.9 % in the placebo group patients. The reduction of LI values at the end of the second, post-treatment phase (day 150) were - again versus the run-in values - 46.2% in the GS, 21.1% in the Pir, 44.6% in the combination, and 9.9% in the placebo group patients.
Concerning cumulative survival in the whole study all in all there were 7 GS (9%), 44 Pir (50%), 18 combination (23%), as well as 36 placebo (45%) group patients, who dropped out of the study because of different reasons (adverse drug reactions, inefficacy, etc.).
In conclusion, GS, is safe as but significantly more effective than placebo in controlling the OA symptoms over a 3-month treatment course and at least as effective as Pir, maintains its symptomatic-therapeutic benefit for at least 2 months while Pir loses its effect after withdrawal.