Clinical Validation Of Traditional Medicine &Natural Products: Experiences and Suggestions

Abstract

Traditional systems of medicine [TSM] use poly-herbal or herbo-mineral combinations for preventive health or for curative aspects of illnesses. The rationale applied is of respective TSM's as in Ayurved or Traditional Chinese Medicine or at times it is mix of ingredients claimed to have beneficial effects for an expected clinical outcome [1]. Validation of these products is difficult in view of their functional approaches that are difficult to correlate with present day critical experimental and laboratory parameters. It is not always possible to translate observational clinical predominance in methods of diagnosis, treatment and evaluation into scientific parameters [2]. Principles and significance of composition, issues of standardization, modifications in original forms or manufacturing processes, newer dosage forms and its dose requirements and administration and such several other issues add to the complexities of clinical validation of TSM products [3]. Clinical study designs and phases followed to evaluate conventional medicine do not serve the purpose of scientific objectivity when applied to TSM. Blind adherence to such methods limit clinical studies to derive true benefits of traditional knowledge base [4]. Varied clinical validation experiences by the author in poorly defined group of musculo-skeletal disorders to specific conditions like osteoarthritis and from common cold to a disease entity like Parkinson's disease indicate need to evolve a systematic approach to clinical validation of TSM products [5–14]. There has been a gradual change in approach to clinical studies amongst the experts dealing with these products and treatments. Reviews and efforts are made to understand utility of such studies and develop newer designs [15]. An urgent need is felt to evolve a systematic approach to clinical validations of TSM products and therapies. The solution lies in dealing with multiple factors that contribute to complexities. Clinical outcome being the benchmark of any treatment, need is to evolve an approach to satisfy needs of TSM principles within the frame of scientific objectivity [16]. Basic need is to integrate principles for well-defined end points and to evolve suitable modalities.