Double-Blind, Randomized, Controlled, Pilot Study Comparing Classic Ayurvedic Medicine, Methotrexate, and Their Combination in Rheumatoid Arthritis
ABSTRACT 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.
Full-textDOI: · Available from: Ram Manohar, Aug 12, 2015
- SourceAvailable from: Clemens Eisenmann
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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)    . 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 . "
ABSTRACT: Ayurveda is playing a growing part in Europe. Questions regarding the role of religion and spirituality within Ayurveda are discussed widely. Yet, there is little data on the influence of religious and spiritual aspects on its European diffusion. Methods. A survey was conducted with a new questionnaire. It was analysed by calculating frequency variables and testing differences in distributions with the χ (2)-Test. Principal Component Analyses with Varimax Rotation were performed. Results. 140 questionnaires were analysed. Researchers found that individual religious and spiritual backgrounds influence attitudes and expectations towards Ayurveda. Statistical relationships were found between religious/spiritual backgrounds and decisions to offer/access Ayurveda. Accessing Ayurveda did not exclude the simultaneous use of modern medicine and CAM. From the majority's perspective Ayurveda is simultaneously a science, medicine, and a spiritual approach. Conclusion. Ayurveda seems to be able to satisfy the individual needs of therapists and patients, despite worldview differences. Ayurvedic concepts are based on anthropologic assumptions including different levels of existence in healing approaches. Thereby, Ayurveda can be seen in accordance with the prerequisites for a Whole Medical System. As a result of this, intimate and individual therapist-patient relationships can emerge. Larger surveys involving bigger participant numbers with fully validated questionnaires are warranted to support these results.Evidence-based Complementary and Alternative Medicine 11/2013; 2013(1):952432. DOI:10.1155/2013/952432 · 1.88 Impact Factor
- 01/2013; 33(1):1-3. DOI:10.4103/0257-7941.134553
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ABSTRACT: Purpose: Complementary and alternative medicine (CAM) has witnessed an increase in use in recent times in rheumatological conditions and is expected to have impact on the quality of life (QOL). We had planned to conduct this study to investigate the extent of use of CAM and its effect on QOL of patients at a tertiary care center. Materials and Methods: Ethics committee approval was obtained. Sixty patients suffering from osteoarthritis (OA) and rheumatoid arthritis (RA) were enrolled as per the selection criteria, after obtaining their informed consent. Each patient was interviewed for CAM use/non-use, and Western Ontario and McMaster Universities (WOMAC) (modified) index for QOL was recorded by the study personnel. Statistical Analysis: The normality was checked by using Kolmogorov-Smirnov test. Descriptive statistics was performed and Mann-Whitney U-test was used to compare the QOL of CAM users and non-users. Results: Of the 60 patients enrolled with OA (10) and RA (50), 58% (35/60) used CAM. Ayurveda and massage therapy were the commonest [80% (28/35)], followed by yoga asana [34% (12/35)] and homoeopathy [20% (7/35)]. It was observed that combinations of therapies were used too. Nearly half [49% (17/35)] of the CAM users were on self-prescribed medication and 71% (25/35) of them did not inform the physician of CAM use. The QOL of CAM users (WOMAC score: 56.31 ± 6.82) was better than that of CAM non-users (WOMAC score: 60.16 ± 4.02) (P value 0.01). Conclusion:Patients with RA frequently used CAM and QOL improvised with CAM use. We observed that self-administration of CAM was common and this was not informed to the treating physician.Indian Journal of Medical Sciences 02/2011; 65(2):50-7. DOI:10.4103/0019-5359.103961