An open-label prospective observational trial for assessing the effect of homoeopathic medicines in patients suffering from gout

Abstract

Background: Gout is an inflammatory arthritis associated with hyperuricaemia and intra-articular monosodium urate crystals, resulting in pain, activity limitation, disability and impact on patients' quality of life. Objective: The objective of this study was to examine the effects of individualised homoeopathic medicines in serum uric acid level and quality of life in patients suffering from gout. Methods: A prospective, single-arm, non-randomised, open-label, observational trial was conducted on 32 adults suffering from gout (diagnosed as per the American College of Rheumatology–European League Against Rheumatism gout classification criteria) at the Outpatient Department of The Calcutta Homoeopathic Medical College and Hospital, Kolkata. Serum uric acid level was the primary outcome (baseline vs. 3 months); Gout Assessment Questionnaire v2.0 (GAQ2; baseline vs. 3 months) and Measure Yourself Medical Outcome Profile v2.0 (MYMOP2; baseline, every month and up to 3 months) were the secondary outcomes. Intention-to-treat sample (n = 32) was analysed in SPSS®IBM® version 20. Results: The mean age of patients was 47.6 years; the male: female ratio was 5:3. Both serum uric acid level (mg/dl) (7.6 ± 1.4 vs. 6.0 ± 1.5; mean reduction: 1.6, 95% confidence interval [CI] = 1.1, 2.1, P < 0.001, Student's t-test) and GAQ2 total score (45.0 ± 9.1 vs. 21.0 ± 14.0; mean reduction: 24.0, 95% CI 19.1, 29.0, P < 0.001, Student's t-test) reduced significantly over 3 months. MYMOP2 scores obtained longitudinally at four different time points also revealed statistically significant reductions (P < 0.001, one-way repeated measures ANOVA). The most frequently indicated medicine was Benzoicum acidum. Conclusion: This study, though preliminary, revealed a positive treatment effect of individualised homoeopathic medicines in alleviating the symptoms of gout and improving the quality of life. More studies like randomised controlled trials with greater scientific rigour are warranted.