Efficacy and Safety of hydroxychloroquine sulphate in rheumatoid arthritis: A randomized, double-blind, placebo controlled clinical trial - An Indian experience

Siddharth Kumar Das, Anil Pareek, D. S. Mathur, Ajay Wanchu, Ragini Srivastava, G. G. Agarwal, R. S. Chauhan

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

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. Research design and 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. Main outcome measures: 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.

Original languageEnglish (US)
Pages (from-to)2227-2234
Number of pages8
JournalCurrent Medical Research and Opinion
Volume23
Issue number9
DOIs
StatePublished - Sep 1 2007

Keywords

  • Disease modifying antirheumatic agents
  • Hydroxychloroquine
  • Indian patients
  • Rheumatoid arthritis

ASJC Scopus subject areas

  • Medicine(all)

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