Hydroxychloroquine sulfate (HCQS) is a popular
disease-modifying antirheumatic drug (
DMARD) despite modest efficacy and toxicity. Ayurveda (ancient India medicinal system) physicians treat
rheumatoid arthritis (RA) with allegedly safer herbal formulations. We report a head-to-head comparison in an exploratory
drug trial. The objective is to compare standardized Ayurvedic formulations and HCQS in the treatment of RA. One hundred twenty-one patients with active moderately severe RA (ACR 1988 classified) were randomized into a 24-week investigator-blind, parallel efficacy, three-arm (two Ayurvedic and HCQS) multicenter
drug trial study; polyherb (Tinospora cordifolia and Zingiber officinale based) and monoherb (Semecarpus anacardium). Study measures included joint counts (
pain/tenderness and swelling),
pain visual analogue scale, global disease assessments, and health assessment questionnaire. Oral
meloxicam (fixed-dosage schedule) was prescribed to all patients during the initial 16 weeks. Patients on
prednisolone could continue a fixed stable dose (<7.5 mg daily). Rescue oral use of
paracetamol was permitted and monitored. All groups matched well at baseline. An intent-to-treat analysis (ANOVA, significance P < 0.05) did not show significant differences by treatment groups. In the polyherb, monoherb, and HCQS arms, 44%, 36%, and 51%, respectively, showed ACR 20 index improvement. Several efficacy measures improved significantly in the HCQS and polyherb groups with no difference between the groups (corrected P). However, the latter was individually superior to monoherb. Only mild adverse events (gut and skin, and none withdrew) were reported with no differences between the groups. Forty-two patients dropped out. This preliminary
drug trial controlled for HCQS demonstrated a standardized Ayurvedic polyherb
drug to be effective and safe in controlling active RA. A better-designed study with a longer evaluation period is recommended.