Hydroxychloroquine compared with placebo in rheumatoid arthritis. A randomized controlled trial.

OBJECTIVE

To assess the efficacy of hydroxychloroquine, 400 mg daily, for rheumatoid arthritis.

DESIGN

Six-month, double-blind, randomized trial.

SETTING

Ambulatory referral clinic in a Mexico City, Mexico, teaching hospital.

PATIENTS

A total of 126 patients with early rheumatoid arthritis were randomly assigned to receive hydroxychloroquine, 400 mg/d, or placebo; 121 patients completed the study.

RESULTS

Hydroxychloroquine showed a clinically and statistically significant improvement over placebo in joint score (20% greater mean improvement; 10% more patients improved by > 50%); pain (40% greater mean improvement; 19% more patients improved by > 50%); grip strength (22% greater mean improvement; 21% more patients improved by > 50%); patient global assessment (16% more patients stated they had improved); and physician global assessment (12% more patients were judged to have improved). Side effects were mild, and no patients in the hydroxychloroquine group required discontinuation of therapy. Patient compliance with the study medication was high.

CONCLUSION

Hydroxychloroquine is moderately effective in early rheumatoid arthritis.