Research Designs Needed in Ayurveda
Table of Contents:
Although there shall be no doubt about the sanctity of a double-blind, randomized clinical trial as for being the gold standard in clinical research, it is faced with much difficulty in traditional medicine research. The complexity of ayurvedic formulations, their intake methodologies, dietary recommendations on the basis of prakrti and bio-physical purificatory processes of paficakarma together make a package of ayurvedic intervention which is often difficult to evaluate through a blinded placebo. A system to system comparison is therefore proposed to find out if there are any significant differences between the two approaches (Kessler and Michalsen 2012). To make such system comparisons more reliable, dummy techniques are often employed, giving an opportunity to treat both the groups with a placebo and a real intervention either of Ayurveda or of modern medicine (Furst et al. 2012). The World Health Organization has recommended a blackbox approach for the clinical research in traditional medicine due to the complexity of various components employed together for treatment in such systems with almost equal weightage to all components (Fatima et al. 2017).This has been found beneficial to seeing what the whole system does rather than getting intrigued by the mechanistic details of individual components. Such mechanistic studies, however, can be of much use in improving the formula further, once the utility of a package is proved.
Besides such clinical trials, a number of other research designs are very useful in the context of Ayurveda. Observational studies that happened to be the most trusted tool of research in Ayurveda for millennia are still a tool of the first order for their capacity to cater to the primary data about epidemiology, preferences, cost and general effects. Longitudinal studies composing big cohorts are supposed to give the most reliable answers to eternal quests of the safety of ayurvedic drugs in the scientific world.
The ayurvedic approach to treating a disease is more individualized and dynamic compared to modern medicine. Ayurveda proposes that pathogenesis is a dynamic process and so has a flexible approach of treatment as per the changing impetus of the host-pathogen interactions. Depending upon their changing relationship in reference to various factors including the drug treatment, the future course of intervention may be entirely different than what has been proposed initially. This is in contrast to the fixed dose and duration regimens of modern medicine where there is little flexibility, and the same course is to be followed either till the termination of the disease or as lifelong therapy. In such cases, N of 1 trials making longitudinal observations in individual patients seems to be the best research design.
Individual case studies and series are still the best learning material in Ayurveda since they bring the individual experiences down to everyone’s understanding and stimulate looking at the causes of such observations occasionally made in practice. Case-based reviews have been the new approach in various journals that allow having a deeper discussion in the case rather than mere reporting of what has been observed (Pierce et al. 2014).
Research Designs for Ayurvedic Core Concepts of Clinical Medicine
Ayurvedic core concepts of clinical medicine like prakrti, tridosa, dma, sapta dhatu dja and agni require some specific postulates and methods for their assessment. These concepts are first required to be clearly elucidated in terms of ayurvedic biology as well as conventional biology, and subsequently methods are required to be generated for their exploration on the basis of existing knowledge. Ama sets a good example of the case. Being the cause of many local and systemic disorders, dma is incriminated as the main culprit in many disorders ranging from joint diseases to gastrointestinal diseases. Looking at the literature, it is clearly seen that the presence and absence of dma are differentiable by a set of distinguishing clinical features. Reduction in dma features in the intervention for the reduction in pathology or samprapti vighatana as postulated in Ayurveda. In the case of joint diseases marked with the presence of я/ия-related features like swelling, stiffness and immobility, upon the adoption of non-steroidal anti-inflammatory drugs (N.S.A.I.D.s), many such symptoms get reduced to some extent transiently. This observation proposes that these N.S.A.I.D.s have яиш-reducing properties from an ayurvedic perspective. Now, since the mechanism of action and the action pathways are well-known for most of the N.S.A.I.D.s, it is possible to relate the ama- reducing ayurvedic drugs with the mechanism of action utilized by the N.S.A.I.D.s. Exploration of prakrti on the basis of genomic studies is another example of such exploratory work.
Agni presents another fundamental dictum of Ayurveda, which is incriminated in almost every disease. Agni has its physiological expressions as hypo, hyper, erratic or normal, reflective of prakrti of the person. There can be pathological expressions as well, incompatible with the prakrti. Genomic studies conducted recently have identified the genetic basis of the speed of metabolism in individuals and identified the subsets of the people as fast metabolizers and slow metabolizers on the basis of gene expressions (Dey and Pahwa 2014). Such metabolic variations, if expressed abnormally owing to various incriminated causes routing through diet and lifestyle, can become the progenitor of disease as is visualized in Ayurveda. Basic ayurvedic approaches to deal with a disease therefore links to the fixing of agni to its normalcy in reference to the agni of the person in the pre-morbid state. As agni has its expression at multiple levels from tissues to cells, this would be hard to get assessed by the colloquial terms of appetite or hunger, expressive of gastrointestinal fire (jathardgni). Dhatvagni and bhUtdgni, playing at the tissue and cellular level, may play more significantly referring to systemic pathology. There are a number of biomarkers expressive of various metabolic activities in the body and their increased or decreased levels may be a clear indication of undergoing biological processes. This may present a fascinating postulate to evaluate dhatvagni and bhiitdgni through levels of biomarkers signifying various biological activities relevant to a particular tissue (Rastogi 2012; Lurie 2012). There can be a number of such novel designs of research to ayurvedic fundamentals of clinical medicine, utilizing the existing tools and by indigenizing their usage as per the needs of Ayurveda.
Modern scientific medicine has become modern and scientific by using two inter-related techniques - measurement and documentation. By being able to reduce any natural phenomena into measurable quantities (take as an illustration of the Bristol Stool scale), modern medicine has been able to “see” patterns and cause-effect relations. The emphasis on documentation has enabled modern medicine to record, disseminate, analyze, criticize and archive knowledge. Put together, measurement and documentation have given concepts like R.C.T.s which enable medicine to become more efficient.
In the case of Ayurveda, neither measurement nor documentation has played a major role in the generation, aggregation and dissemination of knowledge. There was a strong awareness of the need for having high-quality evidence, as shown by concepts like vakyam asamsayam. But at no point was the need felt for quantifying it to render it more measurable; documentation was incidental and mostly for the purpose of archiving and for the intergenerational transfer of knowledge. Therefore, for modern healthcare systems to insist that prakrti scales be developed which may then be reliably compared between different R.C.T.s is asking a little too much. It also misses the point that the intuitional wisdom and heuristic decision making of an experienced practitioner can never be reduced to “modern scientific evidence”. Nevertheless, ayurvedic practitioners have made efforts, and sooner or later, the sheer numbers of these efforts will produce some significant breakthroughs. The challenge for Ayurveda, as indeed for all traditional medicine systems, is to develop its own distinctive systems for generating and utilizing medical evidence. It cannot adopt a cut-and-paste approach from modern scientific medicine.
Chauhan, A., D. K. Semwal, S. P. Mishra, and R. B. Semwal. 2015. Ayurvedic research and methodology: Present status and future strategies. Ayu 36, no. 4: 364-9.
Deveza, L. A., L. Melo, T. P. Yamato, K. Mills, V. Ravi, and D. J. Hunter. 2017. Knee osteoarthritis phenotypes and their relevance for outcomes: A systematic review. Osteoarthritis and Cartilage 25, no. 12: 1926-41.
Dev, S., and P. Pahwa. 2014. Prakriti and its associations with metabolism, chronic diseases, and genotypes: Possibilities of new born screening and a lifetime of personalized prevention. Journal of Ayurveda and Integrative Medicine 5, no. 1: 15-24.
Fatima, S., N. Haider. A. Alam, A. Quamri, L. Unnisa, and R. Zama. 2017. Preventive, promotive and curative aspects of dementia in complementary medicine (Unani): Through-black box design. International Journal of Herbal Medicine 5: 1-5.
Fosse, L. M. 2007. Chapter 2 (Theory). In Blmgavad Gita, 11-16. New York: Yoga Vidya.com.
Furst, D. E., M. M. Venkatraman, M. McGann et al. 2012. Double-blind, randomized, controlled, pilot study comparing classic ayurvedic medicine, methotrexate, and their combination in rheumatoid arthritis. Journal of Clinical Rheumatology: Practical Reports on Rheumatic and Musculoskeletal Diseases 17, no. 4: 185-92.
Kansupada, К. B., and J. W. Sassani. 1997. Documents Ophthalmologica 93, no. 1-2: 159. doi:10.1007/ BF02569056.
Kar, A. C.. R. Sharma, В. K. Panda, and V. P. Singh. 2012. A study on the method of Taila bindu Pariksha (oil drop test). Ayu 33, no. 3: 396-401.
Kessler, C., and A. Michalsen. 2012. The role of whole medical systems in global medicine. Complementary Medicine Research 19, no. 2: 65-66.
Lurie, D. 2012. Ayurveda and pharmacogenomics. Annals of Ayurvedic Medicine 1: 126-8.
Patwardhan, B. 2012. The quest for evidence-based Ayurveda: Lessons learned. Current Science 102: 1406-17. Patwardhan, B. 2013. Time for evidence-based Ayurveda: A clarion call for action. Journal of Ayurveda and Integrative Medicine 4, no. 2: 63-6.
Patwardhan, B. 2014. Bridging Ayurveda with evidence-based scientific approaches in medicine. EPMA Journals, no. 1: 19. doi:10.1186/1878-5085-5-19.
Pierce, R. J., R. Falter, S. Cross, and B. Watson. 2014. Using case-based reviews to improve student exam performance. Currents in Pharmacy Teaching and Learning 6, no. 6: 822-5.
Pietropaolo, M., E. Barinas-Mitchell, and L. H. Kuller. 2007. The heterogeneity of diabetes: Unraveling a dispute: Is systemic inflammation related to islet autoimmunity? Diabetes 56, no. 5: 1189-97.
Rastogi, S. 2010. Building Bridges between Ayurveda and modern science. International Journal of Ayurveda Research 1, no. 1: 41—6.
Rastogi, S. 2012. Prakriti analysis in Ayurveda: Envisaging the need of better diagnostic tools. In Evidence- based practice in complementary and alternative medicine, ed. S. Rastogi, F. Chiappelli, M. H. Ramchandani and R. H. Singh. 99-111. Berlin: Springer.
Rastogi, S. 2019. Understanding diabetes: Uncovering the leads from Ayurveda. In Translational Ayurveda, ed. S. Rastogi, 123-39.Singapore: Springer Nature.
Rastogi, S., and R. H. Singh. 2012. Transforming Ayurveda: Stepping into the realm of evidence-based practice. In Evidence-based practice in complementary and alternative medicine, ed. S. Rastogi, F. Chiappelli, M. H. Ramchandani, and R. H. Singh. 33-49. Heidelberg: Springer.
Shastri, K. N., and G. N. Chaturvedi. 2009.Udara cikitsa adhyaya (Treatment of liver diseases). In Самка Samhita, Part 2, 381-415. Varanasi: Chaukhambha Bharati Academy.
Singh. R. H. 2010a. Exploring issues in the development of Ayurvedic research methodology. Journal of Ayurveda and Integrative Medicine 1, no. 2: 91-5.
Singh, R. H. 2010b. Exploring larger evidence-base for contemporary Ayurveda. International Journal of Ayurveda Research 1, no. 2: 195-6.
Staimez, L. R., M. Deepa, M. К. АН, V. Mohan, R. L. Hanson, and К. V. Narayan. 2019. Tale of two Indians: Heterogeneity in type 2 diabetes pathophysiology. Diabetes/Metabolism Research and Reviews: e3192. doi: 10.1002/d mrr. 3192.
Tripathi, B. N. 1983a. Tisraisaniyam Addhyaya (Chapter dealing with three objectives of life). In Caraka Samhita, Part 1, 223-52. Varanasi: Chaukhamba Surbharati.
Tripathi, B. N. 1983b. Bhumika (Introduction). In Caraka Samhita, Part 1, 5-24. Varanasi: Chaukhamba Surbharati.
Tripathi, B. N. 1983c. DlrghanjivitTya Addhyaya (Chapter dealing with principles of longevity). In Caraka, Samhita, Part 1, 1-49. Varanasi: Chaukhamba Surbharati.
Valiathan, M. S. 2006. Towards ayurvedic biology: A decadal vision Document-2006. Bangalore: Indian Academy of Sciences.
Valiathan, M. S. 2016. Ayurvedic Biology: The first decade. Proceedings of the Indian National Science Academy 82, no. 1. doi:10.16943/ptinsa/2016/v82il/48376.
Wang, В., H. Wang, X. M. Tu, and C. Feng. 2017. Comparisons of superiority, non-inferiority, and equivalence trials. Shanghai Archives of Psychiatry 29, no. 6: 385-8.