A Double-blind, Randomized, Placebo-controlled Trial of Individualized Homeopathic Medicines in Adults with Rheumatoid Arthritis

Introduction: Rheumatoid arthritis (RA) is a chronic autoimmune condition characterized by persistent joint inflammation, pain, and progressive disability. Although conventional disease-modifying antirheumatic drugs improve clinical outcomes, long-term adverse effects and financial constraints highlight the need to explore safe complementary therapies, including individualized homeopathic medicines (IHMs). Current evidence regarding their efficacy in RA remains limited. Objectives: To evaluate the efficacy of IHMs in reducing pain and disease activity in adults with RA compared with placebo. Methods: A 3-month, double-blind, randomized, placebo-controlled study was conducted in a homeopathy hospital in India. Fifty-one patients fulfilling the 2010 ACR/EULAR criteria for RA were randomized in a 2:1 ratio to receive either IHMs or an identical placebo over 3 months. The primary endpoint was the change in Disease Activity Score-28 using ESR (DAS-28-ESR). Secondary endpoints included DAS-28-C‐reactive protein (CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and Measure Yourself Medical Outcome Profile (MYMOP-2). All were measured monthly for 3 months. Analyses were performed on an intention-to-treat basis. Results: Baseline DAS-28-CRP (intervention: 4.1 ± 0.8; placebo: 4.0 ± 0.7) and DAS-28-ESR (intervention: 4.3 ± 0.9; placebo: 4.2 ± 0.8) were similar across groups. At month 3, both groups showed improvement (DAS-28-CRP: 3.0 vs. 3.3; DAS-28-ESR: 3.8 vs. 4.0; MYMOP-2: 3.6 vs. 4.5). CDAI and SDAI scores also improved comparably, with slightly lower medians in the placebo arm. Overlapping 95% confidence intervals suggest no statistically significant differences between groups. Conclusion: IHMs yielded some benefits comparable to placebo, but without any conclusive evidence of impact on disease activity or symptom relief. Trial Registration: CTRI/2023/03/050893.