Efficacy and safety of hydroxychloroquine sulphate in rheumatoid arthritis: a randomized, double-blind, placebo controlled clinical trial--an Indian experience.
OBJECTIVE
Hydroxychloroquine (HCQ) has been used for a long time worldwide as a therapy for rheumatoid arthritis (RA). This trial was designed to determine whether HCQ was efficacious and safe in Indian patients with RA.


METHODS
The trial was a multicentre, placebo controlled, randomized and double-blind study. One hundred and twenty-two patients with RA were enrolled in 3 different centres for the trial (26 males and 96 females in the age group of 18-60 years). Patients were randomized to receive either hydroxychloroquine tablets (n = 61) two tablets of 200 mg daily or placebo (n = 61) two tablets daily. After 8 weeks all patients received one tablet of hydroxychloroquine 200 mg daily for 4 weeks. Every patient also received one tablet of Nimesulide 100 mg twice daily.


METHODS
Assessment of response at 12 weeks using modified ACR 20 (American College of Rheumatology 20) criteria where Health Assessment Questionnaire (HAQ) was replaced by ARA (American Rheumatology Association) functional class.


RESULTS
40.4% of patients on hydroxychloroquine showed improvement by modified ACR response criteria whereas only 20.7% (p = 0.02) showed improvement in the placebo group. No significant side effects were observed in any of the patients. There were no ocular toxicities.


CONCLUSIONS
Hydroxychloroquine was found to be an effective and well-tolerated drug in rheumatoid arthritis in Indian patients.
Das
Siddharth Kumar
SK
Department of Rheumatology, CSM Medical University (formerly King George Medical College), Lucknow 226 003, India.
Pareek
Anil
A
Mathur
D S
DS
Wanchu
Ajay
A
Srivastava
Ragini
R
Agarwal
G G
GG
Chauhan
R S
RS
D000293:Adolescent; D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006886:Hydroxychloroquine / Q000009:adverse effects / Q000627:therapeutic use*; D007194:India; D008297:Male; D008875:Middle Aged; D010919:Placebos
D018501:Antirheumatic Agents; D010919:Placebos; D006886:Hydroxychloroquine