Hydroxychloroquine compared with placebo in rheumatoid arthritis. A randomized controlled trial.
OBJECTIVE
To assess the efficacy of hydroxychloroquine, 400 mg daily, for rheumatoid arthritis.


METHODS
Six-month, double-blind, randomized trial.


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


METHODS
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.


CONCLUSIONS
Hydroxychloroquine is moderately effective in early rheumatoid arthritis.
Clark
P
P
Faculty of Medicine, Universidad Nacional Autonoma de Mexico, Mexico City.
Casas
E
E
Tugwell
P
P
Medina
C
C
Gheno
C
C
Tenorio
G
G
Orozco
J A
JA
D000328:Adult; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006225:Hand / Q000503:physiopathology; D006801:Humans; D006886:Hydroxychloroquine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009132:Muscles / Q000503:physiopathology; D010146:Pain / Q000517:prevention & control; D016059:Range of Motion, Articular
D006886:Hydroxychloroquine