Italian double-blind multicenter study comparing S-adenosylmethionine, naproxen, and placebo in the treatment of degenerative joint disease.

In a double-blind study, the efficacy and tolerability of S-adenosylmethionine (SAMe) were evaluated in comparison with those of placebo and naproxen in the treatment of osteoarthritis of the hip, knee, spine, and hand. Thirty-three centers, 18 rheumatologic and 15 orthopedic, participated in this study. A total of 734 subjects, including 582 with coxarthrosis (hip osteoarthritis) or gonarthrosis (knee osteoarthritis), were enrolled. SAMe administered orally at a dose of 1,200 mg daily was shown to exert the same analgesic activity as naproxen at a dose of 750 mg daily. Both drugs were more effective than placebo (p less than 0.01). Tolerability of SAMe was significantly better than that of naproxen, both in terms of physicians' (p less than 0.025) and patients' (p less than 0.01) judgments and in terms of the number of patients with side effects (p less than 0.05). There was no difference between SAMe and placebo in the number of side effects. Ten patients in the SAMe group and 13 in the placebo group withdrew from the study because of intolerance to the drug.