To address the question of standards of reporting clinical trials of Ayurveda, one must ensure adherence to the three essential pre-requisites of good clinical science. Firstly, reporting must be transparent, honest and accurate; secondly, it must be scientifically unbiased; and thirdly, all interventions used in the trial must be ethical.
In the recent past, design of clinical trials for Ayurvedic interventions has abandoned its multi-component, holistic approach. Instead, trials have blindly emulated the simpler single drug-single disease intervention models used in western medicine. The limitations of this approach have been two-fold: (1) Ayurveda's complete interventions as used in normal clinical practice have not been put to the test; rather, what has been tested has only been some part of the whole intervention normally prescribed; (2) end-points used to signal positive outcome have not been defined in terms of Ayurvedic clinical management principles; nor have creative efforts been made to measure them. This mismatch between Ayurvedic principles and scientific trial design has resulted in conclusions about treatment efficacy that are not in accord with the clinical experiences of practitioners of authentic Ayurveda. These differences have in turn resulted in skepticism concerning Ayurveda's clinical claims in the world of professional medicine.
In the context of developing standards for Ayurvedic clinical trials, it must be firmly asserted that expertise in the use of Ayurveda interventions lies solely with Ayurvedic knowledge holders, and not with their collaborators, including statisticians. It is not wise to advise Ayurvedic physicians on how to conduct Ayurvedic clinical management of any particular health condition. However, fellow scientists and statisticians who are interested in appreciating the Ayurveda knowledge system are fully justified in insisting on honest, accurate, scientifically unbiased, transparent and standardized reporting of all Ayurvedic clinical trials.
Guidelines on reporting (as opposed to conducting) trials will play a major role in establishing credibility of Ayurvedic clinical management. Such guidelines, for example, will require transparency in reporting details for the following points :-
- Reasons for conducting the clinical trial, its underlying rationale? This is important in establishing the ethics, and in ensuring that all human experimentation is in line with the Helsinki declaration on human experimentation.
- Whether the goals of the clinical trial correspond to its stated rationale. This consistency will address the issue of ‘internal validity’ of the trial.
- Whether the trial's design elements ensure that its goals can be achieved. This guideline should include discussion on how the patients/subjects were selected (inclusion and exclusion criteria), how many (to ensure lack of scientific bias), duration of the intervention, and the experience and qualifications of Ayurvedic practitioners conducting the trial. If addressed transparently, the design elements lead to clear understanding of biases.
- Whether the disease under study was appropriately defined i.e. based on Ayurvedic knowledge (listing all end-points associated with the disease with due weightages). Clarity of disease definition helps minimize subjectivity in patient selection, as well as biases in assessing end-points related to the disease.
- Were the various components prescribed for the intervention based on customized diagnosis? Were all details of its complexity included? Clear and full definitions of the interventions used, including placebo or comparator interventions allows others to assess reasons for the trial's failure or success, and will help them replicate the trial should they be interested in doing so.
- Definitions of the end-points indicating a positive outcome for the patient, and how to measure them - success or failure of an intervention depends on objective definitions of the presence or absence of pathology. Along with the previous point on definition of the disease, this helps make reports clearly unbiased in assessing an intervention's success.
- Actual patient history during the trial, including details of patient selection procedures, patient drop-out and associated reasons, and all records of adverse reactions or events? Transparency in reporting individual patient flow during the trial helps in assessing the internal validity of the trial, which is a first step to establishing its external validity.
- Discussions of net results obtained, keeping in mind the original rationale for conducting the trial. Discussions should include points on (1) the internal validity of the trial including clear discussion on how closely conduct of the trial followed its written protocol; (2) external validity of the trial including analyses of results vis-à-vis the latest scientific indicators (e.g. bio-markers, state of the art scientific breakthroughs) and extrapolations of results to a wider population than that studied in the trial.
As previously emphasized, demand for standardization in reporting should in no way restrict Ayurvedic physicians from practicing their art faithfully. Guidelines only go to promote the report's objectivity, scientific validity and ethical considerations. In other words, ‘standards of reporting’ are not about clinical management, but offer guidelines on how to report faithfully, comprehensively and accurately on what actually occurs during trials. Such standards of reporting will allow all readers to enjoy objective conclusions, and obtain better pictures of detailed strategies and ethical norms used in trials.
Various issues concerning clinical trials can be resolved by reporting them completely and accurately. For example: