Double-Blind, Randomized, Controlled, Pilot Study Comparing Classic Ayurvedic Medicine, Methotrexate, and Their Combination in Rheumatoid Arthritis

Geffen School of Medicine, University of California Los Angeles, CA, USA.
Journal of clinical rheumatology: practical reports on rheumatic & musculoskeletal diseases (Impact Factor: 1.08). 06/2011; 17(4):185-92. DOI: 10.1097/RHU.0b013e31821c0310
Source: PubMed


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.
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.
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.
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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    • "Development of a method to allow placebo controls for changing and individualizing therapies is required to facilitate comparison between TMS and western medicine. The approach demonstrated by Furst et al., shows that double-blind, placebo, RCT are possible when testing classic Ayurvedic versus allopathic medications.[47] However, the systematic and controlled setting used in RCT may not always present the complex and dynamic real world of clinical practice.[48] "
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    • "The rather late awareness of spiritual aspects in CAM might be due to the impact that the methodology of Evidence-based Medicine (EbM) had on the medical system as such and in particular on research initiatives in CAM. More recently, after CAM research has managed to close some evidence gaps, researchers have become aware of the necessity to conduct research focused not only on specific evidence but also on unspecific or contextual or patient-centred aspects (related to CAM) [49] [50] [51] [52]. This is by no means in opposition to EbM because one of its founders defined EbM as the integration of (a) the best research evidence with (b) clinical expertise and (c) patient values [53]. "
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    Evidence-based Complementary and Alternative Medicine 11/2013; 2013(1):952432. DOI:10.1155/2013/952432 · 1.88 Impact Factor
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