Clinical research in Ayurveda

Dear Sir,

I wish to comment on the recent publication in Journal of Ayurveda and Integrative Medicine online [1].

They highlight some fundamental issues in clinical research and are to be commended for the drive to improve quality of clinical research.

The presentation of the circular approach to study design rather than hierarchical design is to be highlighted. This approach emphasizes very strongly choosing the study technique that best fits the area under investigation. For example, a study investigating single medicine and its effects on a single symptom, for example pain, requires a different study design than an investigation into a chronic disease with a multiplicity of symptoms.

Their article, however, whilst very clearly presenting limitations of current clinical study techniques, can be added to, by presenting some other options for clinical investigation research techniques.

I present two further approaches.

Recognition of the range of investigative techniques that may provide useful information has led to the “mixed methods approach.” The National Institutes for Health (NIH) in the USA prepared a report (Best practices for mixed methods research in the health sciences. August 2011. National Institutes of Health [2]) discussing the range of methodologies now available. They emphasize research at the public health and large group level using a variety of research methods or a “mixed method” approach. They present criteria for selecting appropriate methods for particular situations.

However Chandra [3] has highlighted clearly the problems with modern biomedical research requiring large numbers to generalize findings to a larger population, where as Ayurveda looks specifically at the individual.

“Clinical research conducted according to protocols set out for modern biomedical research requires that patients be treated using randomised controlled trials.

These necessarily require three things at the minimum: sufficient number of patients, an inclusion and exclusion criteria for the selection of subjects, standardised medicine and sometimes even placebos. Ayurvedic medicine is by its very nature individualised.”

The limitation of projecting results from a trial on a particular sub-group to a population is contrasted with the N equals one paradigm and discussed by Lillie E.O. et al. [4].

“There is a growing acceptance that the development of medical interventions that work ubiquitously (or under most circumstances) for the majority of common chronic conditions is exceptionally difficult and all too often has proved to be fruitless. This recognition has led to the notion that the clinical practice of medicine should acknowledge and embrace the unique characteristics of individual patients, particularly at the genetic level, and seek to individualize patient care.”

“N-of-1 or single subject clinical trials consider an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. The ultimate goal of an n-of-1 trial is to determine the optimal or best intervention for an individual patient using objective data-driven criteria. Such trials can leverage study design and statistical techniques associated with standard population-based clinical trials, including randomization, washout and crossover periods, as well as placebo controls. Despite their obvious appeal and wide use in educational settings, n-of-1 trials have been used sparingly in medical and general clinical settings. We briefly review the history, motivation and design of n-of-1 trials and emphasize the great utility of modern wireless medical monitoring devices in their execution. We ultimately argue that n-of-1 trials demand serious attention among the health research and clinical care communities given the contemporary focus on individualized medicine.”

I would emphasize the benefits of n equal 1 trials in Ayurvedic medicine which is arguably the ultimate in individualised medicine in concept and clinical practice. For rigorous techniques to be applied in the approach clearly defined clinical parameters that can be measured and monitored over time is essential. To date there have been no publications, that I am currently aware of, utilizing this n equals 1 approach within Ayurvedic medicine. I would commend this technique to clinical researchers and suggest that development of robust techniques would then be readily applied by many clinicians to fulfill the lofty aim of each clinician being a researcher. As Patwadhan stated “For the revitalization of Ayurveda and health systems, in general, a large number of Vaidya Scientists and Scientist Vaidyas are needed as the real-change agents [5].”

With rigorous clinical investigation and recording techniques, then many clinical insights from skilled clinicians would be more thoroughly documented and then many other clinicians could benefit from their wisdom.

Clearly there is a long way to go in documenting precisely and researching the many Ayurvedic clinical approaches and the paper by Sridharan and Sivaramakrishnan is a step forwards for the science of Ayurveda.