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Double-Blind, Randomized, Controlled, Pilot Study Comparing Classic Ayurvedic Medicine, Methotrexate, and Their Combination in Rheumatoid Arthritis
Abstract
OBJECTIVE: To compare classic Ayurveda, methotrexate (MTX), and their combination in a double-blind, randomized, double-dummy, pilot trial in rheumatoid arthritis (RA) for 36 weeks. METHODS: Forty-three seropositive RA patients by American College of Rheumatology (ACR) criteria with disease duration of less than 7 years were assigned to the following treatment groups: MTX plus Ayurvedic placebo (n = 14), Ayurveda plus MTX placebo (n = 12), or Ayurveda plus MTX (n = 17). Outcomes included the Disease Activity Score (DAS28-CRP), ACR20/50/70, and Health Assessment Questionnaire--Disability Index. All measures were obtained every 12 weeks for 36 weeks. Analyses included descriptive statistics, analysis of variance, χ², or Student t test. The unique features of this study included the development of placebos for each Ayurvedic pharmacological dosage form and individualization of Ayurvedic therapy. RESULTS: All groups were comparable at baseline in demographics and disease characteristics. There were no statistically significant differences among the 3 groups on the efficacy measures. ACR20 results were MTX 86%, Ayurveda 100%, and combination 82%, and DAS28-CRP response were MTX -2.4, Ayurveda -1.7, and combination -2.4. Differences in adverse events among groups were also not statistically significant, although the MTX groups experienced more adverse event (MTX 174, Ayurveda 112, combination 176). No deaths occurred. CONCLUSIONS: In this first-ever, double-blind, randomized, placebo-controlled pilot study comparing Ayurveda, MTX, and their combination, all 3 treatments were approximately equivalent in efficacy, within the limits of a pilot study. Adverse events were numerically fewer in the Ayurveda-only group. This study demonstrates that double-blind, placebo-controlled, randomized studies are possible when testing individualized classic Ayurvedic versus allopathic treatment in ways acceptable to western standards and to Ayurvedic physicians. It also justifies the need for larger studies.
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“This was a substantive reformulation which became the basis of the controversy between 'pure' śuddha and integrated Ayurveda in the years to come and gained momentum in the post-colonial period, forever influencing the teaching, research, and practice of Ayurveda.$^{1}$^{3}”
From Contemporary Conversations between Ayurveda and Biomedicine (2014) · cites this paper as [13]
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Metadata
- Authors
- Furst, D. E., Venkatraman, M. M., McGann, M., Manohar, P. R., Booth-LaForce, C., Sarin, R., Sekar, P. G., Raveendran, K. G., Mahapatra, A., Gopinath, J., & Kumar, P. R. K.
- Affiliations
- University of Washington (US)
- University of California, Los Angeles (US)
- King Edward Memorial Hospital and Seth G.S. Medical College (IN)
- Corresponding author
- McGann, Mary
- Sekar, P.G.
- ORCID
- Kumar, P.R. Krishna
- Venue
- JCR: Journal of Clinical Rheumatology
- Published
- 2011-06
- Volume
- 17
- Issue
- 4
- Pages
- 185-192
- ISSN
- 1076-1608 (ISSN-L)
- OpenAlex
- W1970808527
- Cited by
- 79
- References
- 18
- Citations by year
- 2026: 4 · 2025: 1 · 2024: 9 · 2023: 7 · 2022: 6 · 2021: 3 · 2020: 6 · 2019: 4 · 2018: 4 · 2017: 4 · 2016: 4 · 2015: 6 · 2014: 6 · 2013: 10 · 2012: 2
- FWCI
- 4.89
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JCR Journal of Clinical Rheumatology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5r21at001969-03)
- National Center for Complementary and Integrative Health (1 R21 AT-01969)
- Topics
- Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Health Sciences › Medicine › Complementary and alternative medicine › Natural Compounds in Disease Treatment
- Keywords
- rheumatoid arthritis, Ayurveda, methotrexate, combination therapy, disease activity, ACR20 response, DAS28-CRP, HAQ-DI, adverse events
- MeSH terms
- Adult, Arthritis, Rheumatoid, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Medicine, Ayurvedic, Methotrexate, Middle Aged, Pilot Projects, Severity of Illness Index, Treatment Outcome, Outcome Assessment, Health Care, Antirheumatic Agents
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