Men-Tsee-Khang Newsletter, Vol XI No.
4 to XIII No. 1 Spring 2004-Autumn 2005
Research & Development
(Projects and activities of a Clinical Research Department)
“Clinical research department has
initiated various collaboration projects and has done numerous
clinical studies, cell line study, toxicity study and health
survey”, writes Dr Tenzin Namdul, a clinical researcher
of the Men-Tsee-Khang.
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 TM further, her early phase of journey was restricted
to preserving the very identity of TM 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 TM grasped the amazing
height around the world and so does the degree of skepticism
about TM 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 TM to reach wider population giving them an opportunity
to be benefitted 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.
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 TM treatment involves advise on diet, behaviour
and external application in the form of paste. TM showed
some 80% improvement though it was not conclusive statistically.
Western medicine showed greater relieve in alleviating pain
while TM 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 TM 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 TM 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 TM can be of use in the treatment
of patients with rheumatic diseases.
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 TM treatment involves
advise on diet, behaviour and external application in the
form of paste. TM showed some 80% improvement though it
was not conclusive statistically. Western medicine showed
greater relieve in alleviating pain while TM 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 TM 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 TM 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 TM can be of use in the treatment
of patients with rheumatic diseases.
2. Diabetes Study
Efficacy of TM 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 TM outline the successful management of
diabetes. However, there is a paucity of systematic research
studies using
modern scientific tools to evaluate the efficacy of TM.
Therefore, we undertook a study to assess the efficacy of
TM 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 TM in management of diabetes mellitus. Further evaluation
of the TM 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 TM 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 TM 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 Cancer 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 accepted by the Ethical
committee.
4. Toxicity Study (Use of Heavy Metal in TM)
Heavy metals (gold, silver, copper, mercury, etc,) are part
of gems and minerals, which forms 5-7% of medicinal substances
used in TM. They are purified applying sophisticated method,
which is one of the unique feature in TM. There have been
numerous speculations over the use of heavy metals in TM
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, 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
TM as Precious pills), 3 patients in Group II (non-mercury
containing TM) 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 TM, 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 TM as Tsothel
is relatively non-toxic. These initials results are of particular
interest in view of the growing popularity of TM 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 TM, with periodic
assessment of biochemical and clinicalmarkers, 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 TM 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 TM
Pokar 10 is often given for the treatment of joint inflammation/pain
and skin diseases.
The cell submitted to concentrations of TM 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 TM 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 TM was able to beneficially
affect the culture cell line. The full report will be pub-lished
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 TM for Hep’ B and another arm getting Traditional
TM for Hep’ B. The primary objective was to evaluate
the efficacy of TM 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
mana-ging 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 TM. This
project comprises series of book on every aspect of diet
from grains, vegetables and fruits -to- different forms
of drinks. The first volume has been published in Tibetan
and the work of its translation is underway.
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
a Clinical Researcher
Men-Tsee-Khang