|Year : 2016 | Volume
| Issue : 4 | Page : 193-194
Evidence for ayurvedic products' efficacy: The devil is in details
D. B. A. Narayana
Chief Scientific Officer, Ayurvidye Trust, 1101, 1F Main, 2ndStage, Girinagar, Bengaluru, Karnataka, India
|Date of Web Publication||10-Aug-2016|
D. B. A. Narayana
Chief Scientific Officer, Ayurvidye Trust, 1101, 1F Main, 2ndStage, Girinagar, Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Narayana D. Evidence for ayurvedic products' efficacy: The devil is in details. Ancient Sci Life 2016;35:193-4
On and off, scientists and clinicians question non availability of scientific information, data to prove the efficacy of Ayurvedic products. In 2016, many dignitaries including the Prime Minister of India pointed to the need for validation of efficacy of Ayurvedic products. The department of Ayurveda, in the Ministry of Health, India has reported its intention to amend the Indian Drugs Regulations to introduce definition and description of what it considers “New Ayurvedic Drug” (which includes currently those ayurvedic medicines that are licensed as proprietary Ayurvedic medicines). For such new ayurvedic drugs the amendment of the regulation proposes to prescribe mandatory human clinical trials before any benefit claims are approved. This amendment describes various provisions to be enforced by the state licensing authorities.
There has been a lot of interest in researching various aspects of ayurvedic products, herbs and ingredients known in Ayurveda in the last decade. Publications of a large number of books, periodicals, monographs in this area both by governmental bodies and private organizations have seen light. Hence a complaint of scientists and clinicians that information on Ayurvedic products and ingredients are not available is not acceptable and is not based on data. Most clinicians' expectation is online searchability and access to information, this should be possible to the same extent as applicable to drugs. All of the information may not be free and like drugs, additional offline search to books and monographs would add value. Searching traditional books of ayurveda (some of them in Sanskrit language) with help of Ayurvedic experts is enriching as is the experience of many.
Most often scientists and clinicians look for evidence for Ayurvedic products in the same way as they are trained with western medicine evaluation. The evidence based medicine approach  has its pitfalls of testing one hypothesis in comparison to a reference product in a randomized trial which may be applicable to single chemical entities. It is to be recognized that Ayurvedic ingredients and products are multicomponent and known to work on multiple organs/targets in the body concurrently. Innovations in clinical research and clinical trials are required to test efficacy of Ayurvedic products. Currently, attempts to capture clinical data in a phase IV like situation including capturing progress or regression of symptoms/variables/biomarkers are ongoing in India at several places on many Ayurvedic products for a number of diseases. An IT enabled tool  developed by Center for Development of Advanced Computing provides a platform where data of the patient including symptoms, disease, diagnosis, treatment, outcome can be captured in an ongoing way and the data can be analyzed. Other methods of evidence generation such as epidemiological data collection and analysis, cohort studies, concurrent evidence generation, congruent evidence generation and population studies on lines similar to large consumer studies are some of the other methods of evaluation that are yet to be tried. A predefined randomized double blind controlled study is usually insisted upon but it has problems of acceptability, cost, time, large number of patients involvement. Opinion on what is an acceptable “n” for such studies differs. Even in those cases where data from one or two statistically significant studies are available, criticism and demand for studies with large number of patients are made.
An eminent medical pharmacologist who later researched into Ayurveda and its products, Dr. Ashok D B Vaidya, in a lecture, cites different modes of evidence namely – observational trials (pratyakṣa), hypothesis testing trials (anumāna), seting up of analogous models and assays (upamāna), situational applications (yukti), cumulative experiences (anubhava), different types of large or controlled trials such as randomized controlled double blind trials/meta-analysis and consensual data/pharmacoepidemiology and surveys (pramāṇa). In an excellent paper, though in a different context describes in great detail “Adapting to concurrent expert evidence in medical litigation”. In this paper, the judge says “concurrent expert evidence constitutes an alternative to the traditional method by which expert evidence is given serially by experts for one side and then the other, in the course of which they are examined and cross examined by the legal representatives for each side. Encompassing pre-trial meetings of experts (conclaves), joint reports by experts and culminating in concurrent evidence at trial ('hot tubs'), once the process is complete one can readily understand that the evidentiary process may be easier”. Indeed, judicial comment about concurrent expert evidence seems almost universally favorable. These observations and methods do to cover the evaluation of the Ayurveda as a system of treatment, which consists of multicomponent approach of diet regulation, exercise, yoga, cleansing of system where needed, and then supported by medicines., and these are not being commented upon.
The demand for evidence of efficacy by scientists and clinicians is common. There is no market research data on whether the patients and the consumers who use ayurvedic products are interested in such data. They go by the advice of the Ayurvedic physicians who prescribe these products to them. The problem arises only when a western biomedicine qualified doctor wants to use and prescribe herbal products which are known in Ayurveda as an adjuvant or replacement or additive or standalone drug to treat their patients. (In spite of the Medical Council of India considering such usage as illegal and quackery). Some of the Ayurvedic firms have invested and generated clinical efficacy data using evidence based medicine protocols with biomedicine qualified doctors as investigators and use such data for promoting the products. Except few firms, the results both in terms of credibility to the firm, acceptability of the product and commercial success have not been noteworthy and market research data in this area is lacking. Do the actual users of these products demand large clinical trial data? Who should generate such data? Can sweeping statements that all Ayurvedic products lack scientific efficacy data be made as is commonly heard? In many synthetic drug trials, partial responses, low level of response in hundred per cent of patients, and non-responding patient population reported in studies are acceptable. Against this, is it right to look for and demand hundred per cent efficacy from ayurvedic products? At what stage should the claims of efficacy be reviewed and approved for ayurvedic products? Should data from in vitro, in vivo methods of evaluation conducted using appropriate methods be acceptable as is done for other products, for ayurvedic products also? These and many other related questions need to be debated and details evaluated.
Exaggerated, misleading, inconclusive claims made without supporting science based data should not be made for all products including Ayurvedic products. Demand for such claim support data should form a part of licensing procedure. Broad guidelines on the nature, type and extent of claim support data acceptable for review should be a step while issuing product licenses. This may put strain on the Ayurvedic product manufacturers who would need to think in depth, shortlist really rational product compositions and develop them with claim support data. The often seen practice of many Ayurvedic products being launched purely based on limited understanding and data along with unsubstantiated claims needs a review. By doing so the industry would be putting their financial and other resources in proper place and would benefit. Medical Council of India, and Indian Medical Association need to review their controversial and illegal position of not permitting MBBS qualified doctors in using herbal products where scientific data is available in their practice and support such doctors to use Ayurvedic products keeping the interest of patients in mind.
| References|| |
Misra A, Gulati S, Luthra A. Alternative medicines for diabetes in India: Maximum hype, minimum science. Lancet Diabetes Endocrinol 2016;4:302-3.
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: What it is and what it isn't. BMJ 1996;312:71-2.
Vaidya AB. Lecture on Ayurveda and Universe of Evidence, at Foundation forRevitalization of Local Health Traditions. Bangalore-11th
April, 2008 (Personal Communication); 2016.
Cockburn T, Madden B. Adapting to concurrent expert evidence in medical litigation. J Law Med 2015;22:610-31.