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Hydroxychloroquine Compared with Placebo in Rheumatoid Arthritis: A Randomized, Controlled Trial

Patricia Clark, MD; Emilio Casas, MD; Peter Tugwell, MD; Clementina Medina, BSc; Constanza Gheno, RN; Guadalupe Tenorio, MD; and Jose Antonio Orozco, MSc
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From Universidad Nacional Autonoma de Mexico and the Hospital General de Mexico, Mexico City, Mexico; Ottawa General Hospital and the University of Ottawa, Ottawa, Canada. Requests for Reprints: Patricia Clark, MD, MSc, Faculty of Medicine, Universidad Nacional Autonoma de Mexico and Hospital General de Mexico, Unidad de Epidemiologia Clinica, Dr. Balmis, 148 Col. Doctores, C.P. 06726, Mexico. Acknowledgments: The authors thank Dr. Alfonse T. Masi for his useful suggestions and Ms. Diane Gagnon for preparation of the manuscript. Grant Support: In part by Sanofi-Winthrop Company, Mexico City, Mexico.

Copyright 2004 by the American College of Physicians

Ann Intern Med. 1993;119(11):1067-1071. doi:10.7326/0003-4819-119-11-199312010-00002
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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.


Grahic Jump Location
Figure 1.
Raw mean scores for joint scores, patient assessment of pain, and grip strength variables for each visit and each treatment group.

VAS = visual analog scale.

Grahic Jump Location




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