Western scientific research studies of traditional medicines are often unsuccessful due to two major factors.

• Lack of therapeutic materials that are reproducible and that accurately represent what is used in traditional practice.
• Inappropriate clinical design and research end-points for traditional medicine.

The western clinical model is overwhelmingly based on a reductionism medical theory that is unsuitable for the patient individualized and whole systems mind/body approach of Traditional Tibetan Medicine. Traditional medical theory utilizes a Systems Theory¹ approach, where the complex interactions of the various mechanisms in a healthy person and their interaction with the environment should result in a balanced state of homeostasis.² Disease and degeneration are an imbalance of this self-regulating system and restoration of the normal balance of functions is the focus of treatment. Research and experimentation is done through clinical observation, theoretical hypothesis and an ongoing systematic documentation and adjustment of treatment as one responds to therapy.

Western medicine has taken a reductionism³ approach where the specific mechanisms of the body are studied in detail to understand their mechanisms of action and altered state in a diseased or traumatic condition (pathology). Treatments are usually focused on intervention in the physiological process to combat the causal agent. Research is done primarily by the scientific method where as many variables as possible are eliminated and a specific variable in the treatment is tested. These are gross over-simplifications of two very dynamic, complex and continuously evolving medical systems. However, it does capture the fundamental differing approaches that have led to differing strengths and weaknesses and why appropriate clinical design is key to evaluate efficacy.

Traditional medicine has excelled in long-term health maintenance and degenerative conditions, utilizing subtle safe therapies and a holistic approach. It is generally less advanced than Western medicine in critical trauma, acute conditions and life-saving interventions. Western medicine has excelled in powerful therapeutics and procedures, critical trauma, acute conditions and life-saving interventions. It is generally less advanced than traditional medicine in long-term health maintenance and care of degenerative diseases, and the high strength therapies of Western medicine often have undesirable side effects. The western acute care model has failed those with chronic conditions and as a result Functional Medicine has emerged to address the needs of chronic conditions.4 Functional Medicine is western systems biology medicine based in research and outcomes with a focus on being predictive, preventive, personalized and participatory. In our experience the integration of Tibetan and Functional Medicines provides the optimal outcome. Why the Integration of Tibetan and Functional Medicines?

• Both are systems biology views of the body that do not focus on the labels of disease but rather how to restore balance.
• Both emphasize the mind-body connection and mental-emotional-spiritual well-being.
• Tibetan medical personalization is based on the 3 nyes pa and 5 elements.
• Functional medicine personalization is based on biochemical individuality and functional labs and is a good counterpart to evaluating the effects of TTM.
• Both seek the root cause of illness. All is connected.
• For both systems, healing begins in the gut.
• Both emphasize the importance of microorganisms.
• Both highlight the role of genetics.
• No two individuals are alike. Both medicines are patient-centered.
• The integration of the two provides optimal outcomes and treatment of chronic illness.

The convergence of systems biology, the digital revolution and consumer-driven healthcare is transforming medicine from its current reactive mode, which is focused on treating disease, to medicine that is predictive, preventive, personalized and participatory.4 N-of-1 clinical trials have evolved in order to personalize medicine for complex chronic conditions.5 Rather than a trial with few variables and many subjects, many variables are evaluated on one subject to better determine how to restore balance.

Because Tibetan medicine has a documented history of safety and efficacy spanning centuries we have the benefit of significant amounts of human treatment history that in the modern world of drug development would cost millions of dollars to develop. Although all botanicals and other natural products are not free from toxicity, those that are toxic are well documented5 and we are not introducing compounds not found in the evolutionary environment into the human system, thus greatly minimizing the risk and expense of new product development.

We want to establish several clinical/retreat sites to achieve the following:

• A place for trained Tibetan doctors to practice and learn integration.
• A place for trained Western doctors to learn Tibetan medicine and integration.
• To disseminate the benefits and positive image of Tibetan medicine.
• To integrate Tibetan and Functional Medicines for optimal east-west integration.
• To experiment with alternative clinical study models and clinical end-points
• To study the benefits of Functional Tibetan Medicine for chronic illness.

In conjunction with the more traditionally based clinics/retreats we want to continue our theoretical work in establishing cutting edge modern integration of western scientific tools and theory with traditional medicine and theory. We previously showed a correlation of molecular and macroscopic markers of Multiple Sclerosis (MS) when both are interpreted from the theories of Tibetan medicine. This provides a new view to understanding and treating MS.^6,7 We have now entered an era of big data in medicine that some seek to simplify with computer algorithms. As how we simplified brain lipid data in MS with Tibetan medical theories, we are correlating clinical markers used in functional medicine of epigenetics, the microbiome and metabolic and nutritional status with Tibetan medical theories of the 3 nyes pa and 5 elements to simplify big data and it is proving helpful for those with complex chronic illness such as MS, ALS, myasthenia gravis, muscular dystrophy, and mood disorders among others. We are at initial stages of this clinical integration and seek funding to expand our clinical and theoretical integration.

In alignment with Tibetan medical approaches, we seek to conduct 3-week healing retreats with use of Tibetan therapeutic herbal baths in the spring and autumn for two years for people with MS. Outcomes of this study are aimed at supporting a new model of care for chronic, disabling conditions. Ideally this study would begin with enough time to complete the following Aims beforehand:

• Translations of herbal preparations will be completed and all formulas verified for translation and spelling and entered into an interactive database with known information about individual constituents (ingredients, mechanism of action, common and botanical name, etc.).
• The mineral content of three Tibetan mineral-herb pills will be determined.
• Tibetan nutritional guidelines will be described for 7 different states of MS, based on 3 nyes pa constitution.

Upon completion of the Outcomes study, we will have better designed guidelines for a larger, more comprehensive clinical study of Functional Tibetan Medicine and MS, ideally at two sites with MRI and laboratory correlates and with the use of standardized herbs and herbal formulas.

Ultimately, it is envisioned that a third clinical site will contain a basic research lab for continued study of Tibetan medicine. First, herb characterization must be completed, as previously described, so that consistent and reliable studies can be done in the lab. In addition to an herb characterization lab and research farm, there will be basic scientific studies in physical chemistry and cell biology for further microscopic explorations of the effects of Tibetan medicine on nervous system regeneration. Basic studies will be aimed at providing data to support clinical studies of Tibetan medicine and enhance new drug delivery as Traditional Tibetan Medicine is applied to modern, chronic disabling conditions. University collaborations relevant to MS are in the physical characterization of myelin membranes, nutrition, and cell culture of myelin. Tibetan medicine, or gso ba rig pa, has the prediction of outcomes built into its theory as well as individualized mind-body treatment, and holds great promise for providing alternative models of care for chronic disabling conditions.

¹ Systems Theory studies the nature of complex systems in nature, society, and science. More specifically, it is a framework by which one can analyze and/or describe any group of objects that work in concert to produce some result.- Wikipedia
² Homeostasis is the property of a system, especially a living organism, which regulates its internal environment so as to maintain a stable, constant condition. - Wikipedia
³ Reductionism is a philosophy or approach to understanding the nature of complex things by reducing them to the interactions of their parts, simpler or more fundamental things. - Wikipedia
⁴ https://www.ifm.org/
⁵ Albert Y. Leung, Traditional Toxicity Documentation of Chinese Materia Medica An Overview 10.1080/01926230600773958 Toxicol Pathol 2006; 34; 319. Link to article: http://tpx.sagepub.com/cgi/reprint/34/4/319
⁶ http://www.p4mi.org/p4medicine
⁷ Husted C and Dhondup L. Tibetan medical interpretation of myelin lipids and multiple sclerosis. Ann NY Acad Sci, 2009; 1172: 278-296.
⁸ Dhondup L and Husted C. Regeneration and Tibetan medicine. Ann NY Acad Sci, 2009; 1172: 115-122.
⁹Husted C. and Dhondup L. Bridging the Gap Between Science and Traditional Medicine: Microscopic and Macroscopic Agreement of Three nyes pa Descriptions of Multiple Sclerosis. In Mingji Cuomu, Sienna Craig, Francis Garrett and Mona Schrempf (eds.), Studies of Medical Pluralism in Tibetan History and Society. (Proceedings of the 11th Seminar of the InternationalAssociation for Tibetan Studies, Bonn 2006). Andiast: International Institute for Tibetan and Buddhist Studies GmbH (IITS), 2011.