Double-blind randomized trial of diclofenac sodium versus placebo in patients with rheumatoid arthritis.

In a six-week, double-blind, randomized, multicenter clinical trial, the efficacy and safety of 150 mg/day of diclofenac sodium and a placebo were compared in 182 patients with active definite or classical rheumatoid arthritis. Safety and tolerability were evaluated in all patients and efficacy was determined in a subset of 158 patients who met all criteria for eligibility. A significantly greater improvement in six of eight treatment variables was seen in the diclofenac-treated patients than in the placebo group after one week of therapy. Fewer diclofenac-treated patients than placebo-treated patients discontinued the study because of lack of therapeutic response. Adverse experiences were reported by 28% of the diclofenac group and 21% of the placebo group, not a statistically significant difference. Gastrointestinal complaints were the most frequently reported side effects in both treatment groups, but there was no significant difference between the treatment groups. Diclofenac was found to be effective, safe, and well tolerated for the treatment of patients with active rheumatoid arthritis.