Since the re-establishment of Men-Tsee-Khang (MTK) in 1961, MTK has worked consistently and furiously in fulfilling its primary objective of preserving, promoting and developing Tibetan medicine (TM) further other than striving to contribute in lessening the world sufferings. Even though MTK has always realised the importance of initiating a research study and developing Tibetan Medicine further, her early phase of journey was restricted to preserving the very identity of Tibetan Medicine due to the dire situation and limited resources. MTK was able to stretch further by early 1980 owing to growth of staff and wider infrastructure. Research & Development (R&D) department was first incepted in 1984 building the initial block of documentation and case studies.

The popularity of Tibetan Medicine grasped the amazing height around the world and so does the degree of skepticism about Tibetan Medicine in medical fraternity. As often stressed by His Holiness the Dalai Lama, the need of doing a clinical study and initiating a collaboration work was felt strongly not only to evaluate and authenticate this system but also to enable Tibetan Medicine to reach wider population giving them an opportunity to be benefited from it.

Clinical research department has initiated various collaboration projects and has done numerous clinical studies, cell line study, toxicity study and health survey. Following are the projects that have been completed with some very interesting results.

1. Rheumatoid Arthritis: A pilot study on the effect of Tibetan medicine on patients with rheumatoid arthritis was done in collaboration with Institute of Biological Anthropology of Oxford University for three months from 1st May - 30th July 1994 at MTK branch clinic at McLeod Ganj, Dharamsala. There were 103 patients and it was a comparative study between Tibetan and Western medicine. The Tibetan Medicine treatment involves advise on diet, behaviour and external application in the form of paste. Tibetan Medicine showed some 80% improvement though it was not conclusive statistically. Western medicine showed greater relieve in alleviating pain while Tibetan Medicine showed more improvement in the joint movement. The paper was published in Men-Tsee-Khang official Tibetan Journal in its IV volume.

Another pilot study was done in collaboration with Dutch Foundation for Tibetan Medicine for 12 months from March 1996 - March 1997. The primary objective was to register the effect of Tibetan Medicine on the treatment of patients with rheumatic diseases. It was an open label, non-interventional, single-centre, phase IV pilot study. The patient received the Tibetan Medicine next to their usual treatment, if any. After a year treatment, improvement can be seen in 9 out of 12 parameters. Since only subjective parameters were measured in this pilot study, a clinical trial measuring also objective parameters (such as: hemoglobin, platelets, blood sedimentation rate and immunoglobulins) is crucial to prove if Tibetan Medicine can be of use in the treatment of patients with rheumatic diseases.

2. Diabetes Study: Efficacy of Tibetan Medicine as an adjunct in the treatment of type 2 diabetes was done in collaboration with All India Institute of Medical Sciences (AIIMS), New Delhi, India. Diabetes is the most frequently seen chronic disease in MTK clinics. Ancient texts of Tibetan Medicine outline the successful management of diabetes. However, there is a paucity of systematic research studies using modern scientific tools to evaluate the efficacy of Tibetan Medicine. Therefore, we undertook a study to assess the efficacy of Tibetan Medicine when combined with a diet & exercise regimen compared with a diet & exercise regimen alone in controlling the blood glucose and glycated hemoglobin (GHb) in newly diagnosed or untreated type 2 diabetes. A total of newly diagnosed or untreated type 2 diabetic patients, who were eligible and consented to participate in the trial, were recruited from two branch clinics of MTK.

At each centre, all of the 200 subjects, 136 men and 64 women, were randomised into two groups, the treatment group and the control group. Fasting blood glucose levels decreased by 12.2 ± 30.5% at 12 weeks and by 23.4 ± 20.0% at 24 weeks in the treatment group as compared with 7.4 ±30 and 6.4 ± 27.7% in the control group. The PPG measurement was significantly lower in the treatment group at 12 and 24 weeks (decrease of 18.0 ± 31.2 and 23.4 ± 27.1%) compared with the control group (decrease of 5.5 ± 32.9 and 10.0 ± 41.2%). At 12 weeks, the percentage decrease in GHb levels was 1.9 ± 35.8% in the control group compared with 17.5 ± 31.3% in the treatment group. At 24 weeks, the decrease in GHb was 21.8 ± 30.1% in the treatment group compared with 6.7 ± 29.3% in the control group. There was no significant change in body weight, blood pressure, or serum lipids in either group.

The preliminary trial has shown a positive effect of the use of Tibetan Medicine in management of diabetes mellitus. Further evaluation of the Tibetan Medicine in treating patients with DM will require blinded placebo controlled trails, and comparison of this system with other oral hypoglycemic agents.

The American Diabetes Association, Inc, published the study as an observation letter in Diabetes Care 24: 176-177, 2001. The study’s full report was published by Men-Tsee-Khang and presented to His Holiness the Dalai Lama during His visit to MTK on 7th Dec’ 2000.

Diabetes Survey: A descriptive study was done to study the prevalence of diabetes mellitus in Tibetan settlements in South India in December 1997. There has been no reported study of DM among the Tibetan population. In this study, the crude prevalence rate of DM was 4.3%. DM can be considered to be a significant problem in this migrant Tibetan population. One also needs to take note of very high prevalence of hypertension in the Tibetan population. A note should also be made of a possibly high occurrence of cerebrovascular disease. Separate studies on hypertension and stroke are needed to confirm their high prevalence.

3. Cancer Study: Cancer is one of the chronic diseases Tibetan Medicine has shown some positive effect depending on the stage of the disease. The need to design a clinical study was felt for a long time and during a meeting on cancer in 1996, it was decided to commence with a base-line study before launching on a clinical study. The objectives of this study was to identify the type of cancer Tibetan Medicine is most effective; the stages of cancer; alleviating the symptoms; improving the quality of life & life span, and to specify the particular Tibetan drugs for cancer. The base-line study went through 1998 - 2001 registering 638 Ca patients from 15 MTK’s branch clinics. The study showed marked improvement in alleviating the symptoms; controlling the disease; improving the quality of life physically & mentally and pre-longing the life span. 9 patients were reported completely cured.

Based on this preliminary study, a clinical study on ovarian cancer was designed in collaboration with All India Institute of Medical Sciences (AIIMS), New Delhi. The study proposal has been submitted to AIIMS’s Ethical committee. The study will be commenced once it is accept by the Ethical committee.

4. Toxicity Study (Use of Heavy Metal in Tibetan Medicine): Heavy metals (gold, silver, copper, mercury, etc,) are part of gems and minerals, which forms 5-7% of medicinal substances used in Tibetan Medicine. They are purified applying sophisticated method, which is one of the unique feature in Tibetan Medicine. There have been numerous speculations over the use of heavy metals in Tibetan Medicine over last few years. MTK has taken such speculations in her stride and had decided to design a toxicity study to authenticate this unique method of formulating purified mercury therapeutically.

The study was planned as an open, retrospective, controlled pilot study, constituting an initial feasibility stage of a larger, future prospective study. The study was done in collaboration with Natural Medicine Research Unit, Hadassah Medical Organization, Jerusalem, Israel; Delek Hospital, Dharamsala, India; Dept. of Toxicology, Sheba Medical Center Tel Aviv, Israel and Dept. of Chemistry, University of Liverpool, Liverpool, UK.

Study participants were recruited from the outpatients department of the Delek Hospital where Western medicine is practiced. The volunteers who agreed to act as controls were recruited from the personnel working at MTK, known to be in good health. A total of 11 participants (9 patients, 2 controls) were recruited into the study. Each participant were examined and questioned by Western trained physicians at the Delek Hospital for any physical symptoms that include cardiovascular evaluation and a neurological examination (tremor, peripheral sensory neuropathy, motor neuropathy and tunnel vision). An oral examination evaluated the presence of loose teeth and dental fillings. Blood and urine sample was taken for evaluation in the Delek Hospital laboratory.

For analysis of whole blood and urine for mercury levels, the samples were transported to Israel in ice pack through air courier. They were delivered by hand to the Dept. of toxicology, Sheba Medical Center, Tel Aviv, Israel.

Results: A total of 11 patients were evaluated for the study. They included 6 patients in Group I (mercury containing Tibetan Medicine as Precious pills), 3 patients in Group II (non-mercury containing Tibetan Medicine) and 2 participants in Group III (Controls). General and neurological examination were normal in group I & II. The mean serum level of liver and renal functions tests were within the normal clinical range and did not differ significantly between treatment and control groups. Evaluation of urine samples for red blood cells and protein were negative in all 3 groups. Serum mercury levels were non-detectable in all patients in Groups I, II & III. Mean urinary mercury levels were under normal range.

Although the study was small representing only the feasibility stage of a larger, future prospective study, nevertheless the results are of interest. It demonstrate for the first time that the patients ingesting high levels of mercury present in certain Tibetan Medicine, over a pre-longed period of time, displayed little evidence of toxicity. The current study, although performed on only a small cohort of patients tend to support the hypothesis that a pre-longed intake of the “purified” form of mercury, known in Tibetan Medicine as Tsothel is relatively non-toxic. These initials results are of particular interest in view of the growing popularity of Tibetan Medicine in the West, however there is no doubt that further research needs to be performed.

A much larger prospective clinical study should be undertaken in patients taking mercury-containing Tibetan Medicine, with periodic assessment of biochemical and clinical markers, as well as serial documentation of mercury levels in serum, urine, hair and other tissues. In addition, the potentially therapeutic effect of purified mercury and precious pills should also be evaluated using well-defined laboratory models to identify the specific bioactivity of these preparation.

5. Cell Line Study: The purpose of this study was to explore the possible stimulating effects of the Tibetan Medicine called Pokar 10 in two cell types that have been stressed in an impoverished medium over 5 days. This study was carried out in May 2004 in collaboration with Tissue Culture laboratory at Portland Community College, Portland, Oregon, USA. Both cell types were fibroblasts, fast growing connective tissue cells secreting an extra-cellular matrix rich in collagen and other macromolecules. The Tibetan Medicine Pokar 10 is often given for the treatment of joint inflammation/pain and skin diseases.

The cell submitted to concentrations of Tibetan Medicine were noticed to be growing “extensions” to their cytoplasmic material, appearing to reach specifically for the Tibetan compound, grabbing and engulfing bit of it. This movement in the direction of the Tibetan Medicine can be referred to as a positive chemotactic response. Further testing would be required to continue documenting the earlier responses of the fibroblast cells, and also to attempt to understand and explain the physiological mechanisms by which the Tibetan Medicine was able to beneficially affect the culture cell line. The full report will be published in forthcoming Men-Tsee-Khang (English) official journal.

6. Hepatitis B Study: A clinical study on Hepatitis B was started from April 2004 to December 2004. It was an Open Randomized Control Single Centre Study. After obtaining patient’s consent, 50 patients were selected following WHO selection criteria. The patients were grouped into two arms with one arm getting Specific Tibetan Medicine for Hep’ B and another arm getting Traditional Tibetan Medicine for Hep’ B. The primary objective was to evaluate the efficacy of Tibetan Medicine in treating Chronic Hepatitis B patient.
The result didn’t display any conversion from positive to negative but it certainly showed significant improvement in Liver Function Test (LFT) and alleviating related symptoms. The data has been fitted in the computer and are awaited being statistically analysed by the statistician.

7. Hypertension Survey: The findings of high rate of hypertension and stroke during the diabetes survey in Tibetan settlements in South India in December 1997 lead to this study. It is a descriptive study that was designed to study the prevalence of hypertension in exile Tibetan community. The whole Tibetan community in Northern India (except Dalhousie) has been covered screening some 6000 people. Along with screening people for hypertension, a specially designed form for each participant is filled by the field- investigating doctor. People are educated about the cause and preventive measurement of hypertension and the hypertensive people were advised accordingly in managing their blood pressure. The data will be analysed once the particular region is covered up.

8. Public Health Intervention: Public Health Intervention is taken as one of the other means of improving the health care system in community by this dept. Couple of projects that are on the floor:

i) Diet Book: Diet is considered as one of the important tools in sustaining health and treating disease in Tibetan Medicine. This project comprises series of book on every aspect of diet from grains, vegetables and fruits -to- different forms of drinks. The first volume of this book series has been published both in Tibetan and English Language.

ii) Health Education: In order to reach masses, a special program of educating common people about the health and diseases are initiated by using different media platforms like radio and local newspaper.

As prepared by:
Dr. Tenzin Namdul
Clinical Researcher