title: Comparable efficacy of standardized Ayurveda formulation and hydroxychloroquine sulfate (HCQS) in the treatment of rheumatoid arthritis (RA): a randomized investigator-blind controlled study.
abstract: 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.
authors.affiliation: Centre for Rheumatic Diseases (CRD), 1988 Convent Street, Hermes Elegance, Camp, Pune, 411001, India. crdp@vsnl.net
authors.forename: Arvind
authors.initials: A
authors.lastname: Chopra
authors.forename: Manjit
authors.initials: M
authors.lastname: Saluja
authors.forename: Girish
authors.initials: G
authors.lastname: Tillu
authors.forename: Anuradha
authors.initials: A
authors.lastname: Venugopalan
authors.forename: Gumdal
authors.initials: G
authors.lastname: Narsimulu
authors.forename: Rohini
authors.initials: R
authors.lastname: Handa
authors.forename: Lata
authors.initials: L
authors.lastname: Bichile
authors.forename: Ashwinikumar
authors.initials: A
authors.lastname: Raut
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Sarmukaddam
authors.forename: Bhushan
authors.initials: B
authors.lastname: Patwardhan
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D020939:Zingiber officinale; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use*; D007194:India; D008297:Male; D008515:Medicine, Ayurvedic; D008875:Middle Aged; D010147:Pain Measurement; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D031023:Semecarpus; D016037:Single-Blind Method; D031610:Tinospora; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D010936:Plant Extracts; D006886:Hydroxychloroquine