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Alternative medicine goes mainstream for better health
care delivery
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| Muhammed
Majeed, Ph.D.,
President & C.E.O
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Lakshmi
Prakash, Ph.D. ,
Vice President, Medical and Scientific
Affairs |
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Sabinsa
Corporation New
Jersey, U.S.A. |
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Paper
presented at the 49th Indian Pharmaceutical
Congress, Thiruvananthpuram,
December 18-21, 1997. |
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| Introduction |
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The
alternative medicine movement in America owes
its beginnings to people who understood the fact
that health care obtained from physicians, pharmacists,
osteopathic doctors, chiropractors and other health
professionals, needs to be nurtured by a more
accessible self-applied therapeutic approach.
Therefore, it is not surprising that the movement
did not originate in the Universities, Medical
Schools or doctors’ offices. It was born
at MLM meetings, in the basements of private houses
and at mom & pop stores and businesses. The
popularity of alternative medicine in recent years
validates the relevance of sociological change
in progress of any kind.
Today, "the alternative goes
mainstream." Phytochemicals, nutraceuticals,
antioxidants, bioprotectants and a host of related
terminology have become household words. A number
of unconventional therapeutic approaches are gaining
popularity, to the extent that health insurance
companies in the US have begun to cover alternative
tharapies. It is now the turn of health professionals
to educate themselves and merge this newly acquired
knowledge with their conventional training. The
resulting comprehensive approach to prevention
and treatment of diseases would benefit patients
greatly. This article highlights some of the scientifically
validated features of the materia medica employed
by two important members of the alternative medicine
family, Ayurveda and Tibetan medicine.
The therapeutic modalities offered
by these traditions preserve the following characteristics:
| 1. Safety |
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The safety of
individual botanicals, minerals and compound
formulae has been established through hundreds
or even thousands of years of sustained
use. Many of these treatments have outstanding
records of safety and effectiveness. In
addition some of the botanicals used in
Ayurveda, for example peppers, are among
the first plants to be cultivated for human
use. |
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| 2. Broad action
on the macro-organism. |
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The terms adaptogen and more
recently, bioprotectant were developed on
the basis of the mechanisms of action of
several plants derived from Ayurveda materia
medica. For example curcuminoids or derivatives
of Curcuma longa (turmeric) are now being
recognized as versatile phenolic anti-oxidants,
providing two-fold anti-oxidant activity:
prevention of free radical
formation andintervention, to neutralize
existing free radicals.
This action of curcuminoids
exemplifies the characteristic mechanism
of action of therapeutic ingredients called
"bioprotectants".
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| 3. Attention to
the digestive processes. |
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Another recognized feature of
Ayurveda and the related Tibetan medicine
is the emphasis on proper functioning of the
digestive tract, more specifically, the digestion
and absorption (bioavailability) of food,
nutrients, and (when necessary) drugs. The
Ayurvedic approach to primary care of the
digestive tract consists of providing a digestive
formula to correct the suspected nutritional
problem. Secondary care is provided by supplementing
various formula with a digestion-enhancing
component. Importantly the nutrient for the
"digestive process" is understood
in Ayurveda not only as food we eat, but also
includes the air we breathe and more significantly,
the "food" that feeds our mental
and emotional processes. |
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| Scientific
validation of this therapeutic approach |
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In recent years,
the emphasis has been on obtaining authentic
clinical data that endorse the health benefits
of herbal approaches to the management of
diseases. Scientists and medical researchers
continuously work to isolate active principles
from healing herbs and elucidate their mechanisms
of action. Several herbs from the Ayurvedic/Indo-Tibetan
materia medica have been subjected to controlled
clinical trials in the management of a number
of diseases. Some of these studies are outlined
in the here. |
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| Gastroenterology
- clinical trials |
| 1. Nutrient
bioavailability |
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Recent clinical
studies done by Sabinsa Corporation of New
Jersey have shown that the alkaloid piperine
isolated from Piper nigrum (fam.
Piperaceae) black pepper enhances
the bioavailability nutrients. In several
separate double-blind clinical trials healthy
volunteers were administered 95% pure piperine
in a dose of 5 mg per day together with
a conventional nutrient. Vitamin B6
was administered at one time dose of 100
mg, beta carotene was administered at a
dose of 15 mg/day (14 days), vitamin C was
administered at a dose of 100 mg/day (5
days), selenium was administered at 50 mcg/day
(42 days) and Coenzyme Q10 was
administered at 120 mg/day (21 days). Results
showed that gastrointestinal absorption
of all the nutrients studied, evaluated
on the basis of blood levels present, increased
significantly on co-administration with
piperine. Piperine administered with vitamin
B6 resulted in 2.5 times higher
blood levels (as compared to control group
receiving vitamin B6 alone),
two hours after supplementation. Similarly,
blood levels of beta carotene increased
by 60% over the control levels; blood levels
of selenium resulted in a 30% increase;
blood levels of Coenzyme Q10
increased by 30% (Badmaev V, Majeed M, Passwater
R. Alt Ther. July 1996; 2(4):59-67).
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| 2. Upper
gastrointestinal disorders |
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The fruits
of Terminalia chebula (fam. Combretaceae),
Terminalia belerica (fam. Combretaceae),
and Emblica officinalis (fam. Euphrobiaceae)
combined in equal proportions constitutes
Triphala. This formula and its individual
ingredients are highly valued in Ayurveda,
being compared to a "good manager of
the house", aiding digestion, nutrient
absorption and body metabolism. Triphala
is used either alone or in a compound formula
in the management of a broad range of digestive
disorders, including psychosomatic conditions
affecting the gastrointestinal tract. Triphala
is
an ideal example
of adaptogenic herbals that have beneficial
effects on the digestive tract and general
metabolism.
A comparative
study of the efficacy of Emblica officinalis
fruit powder with a conventional antacid
formulation was performed. In a 4 week study,
38 patients with dyspepsia and with or without
stomach ulcer were divided into two groups
: one group received the fruit powder and
the other, the antacid. Emblica was
used at the level of 3 gm per dose, three
times a day while gel antacid was used at
30 ml per dose, up to 6 times a day. The
improvement in the clinical symptoms score
(belching, fullness, heartburn, regurgitation,
nausea and vomiting) in ulcer dyspeptics
was from the initial 4.2 to 0.4 (p <
0.01) post treatment score for antacid group,
and 4.6 to 0.6 (p<0.05) for the Emblica
group. The fall in peak acid output was
not statistically significant in the two
groups. Endoscopic examination showed all
ulcers in the antacid group in the process
of healing, while all but one patient in
Emblica group had completely healed
ulcers. In the non-ulcer group antacid and
Emblica produced a significant decrease
in clinical symptoms score from 4.4 to 1.53
(p<0.01) and 5.0 to 1.61 (p<0.01)
respectively. The peak acid output fell
for antacid and Emblica treated patients
from 20.01 mEq/h to 14.7 mEq/h (p < 0.001)
and 20.56 mEq/h to 15.5 mEq/h (p < 0.001)
respectively (Chawla YK. Indian J Med Res
76 (suppl) December 1982: 95-98).
Tisanax
is a traditional multicomponent gastrointestinal
formula of Tibetan origin available in the
form of 255 mg tablets The product has been
tested in a 4 week open field study in Switzerland
by four independently working physicians.
A total of 52 patients of both genders with
irregular gastrointestinal (GI) functions
manifested by constipation, flatulence,
feeling of fullness, heartburn and belching
participated in this study. 43 participants
reported a significant (p<0.001) improvement
in GI functions after consuming Tisanax
at the level of 1 to 3 tablets a day. Tisanax
eliminated gas in 80% of patients, heartburn
in 83%, abdominal fullness in 76% and constipation
in 74%. 85% of patients reported relief
within one week after taking 1 to 3 tablets
per day. Those patients who had no history
of laxative use or had previously used mild
laxatives, benefited most from therapy with
Tisanax (Badmaev, V unpublished data, 1997).
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| 3. Liver disorders
- clinical trials |
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Protection
against the negative impact of inappropriate
nutrition is provided almost entirely by
the liver. The liver with its foot-soldiers,
the macrophages and the enzymes that catalyze
detoxification processes, is our bodys
first line of defense against a broad range
of toxic materials. Ensuring proper liver
function represents the key to succesful
treatment of several diseases.
The powdered
leaves of Phyllanthus amarus (fam.
Euphorbiaceae, Sanskrit name Bahupatra)
were used in clinical studies evaluating
its usefulness in patients suffering from
chronic damage to the liver due to the protracted
hepatitis B virus infection. This
type of infection results in inability of
the bodys immune system to eliminate
the virus from the liver cells. This condition
is described as a carrier state, because
a continuously harbors the virus. Some of
the components of the virus detectable in
the carrier state in the blood are: HBsAg
or the surface antigen of the virus and
HBeAg or the envelope antigen of the virus.
In addition, the carrier state may be confirmed
by the presence of antibodies directed against
the core of the virus or the anti-HBc antibodies.
The antibodies indicate that human organism
is attempting to defend itself against the
infection, but the longer this defense goes
on the more collateral damage is done to
the liver.
The powdered
leaves of P. amarus were given in
form of capsules to the group of 37 patients
with chronic viral hepatitis B in a dose
of 200 mg three times a day for 30 days.
23 patients with identical diagnosis received
placebo capsules. 22 of the 37 (59%) among
the P. amarus treated patients tested
negative for the viral antigen 15-20 days
after the end of the treatment. In contrast,
only one of 23 (4%) placebo-treated patients
lost the carrier status. Some of the participants
who cleared the viral antigen were followed-up
in the laboratory tests for up to 9 months,
within practicable limits of out patient
monitoring. None of the followed-up cases
showed traces of reacquired antigen, indicating
complete success of the treatment. Only
one of the 37 patients treated with P.
amarus, a two and a half years old boy
developed an untoward effect in form of
a skin rash, after 10 days of the therapy.
The supervising physician attributed the
rash to an inherent roundworm infection
in the patient, rather than to the P.
amarus treatment.
The authors
of the paper discuss a possible mechanism
of action of P. amarus based on preclinical
studies done with hepatitis B like viruses,
chronically infecting woodchucks. They postulate
that P. amarus may inhibit proliferation
of the virus by directly inhibiting replication
of the genetic material of the virus (DNA),
viz., by inhibiting the DNA polymerase of
the hepatitis virus. Phyllanthus amarus
contains sesquiterpene alkaloids. The active
principle or principles responsible for
the hepatoprotective action of P. amarus
are not established as yet. |
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| II. Psychiatry
- clinical trials |
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| 1. Management
of mental depression |
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In the Ayurvedic
approach to health care, an individual’s
mental and emotional well-being is as important
as the proper functioning of the digestive
system. In fact, processing of thoughts
and emotions by appropriate centers in the
brain is often referred to as "digestion
at mental and emotional levels." Ayurveda
links many physical disorders to a temporary
or chronic deterioration of our psychological
and emotional comfort. While it is generally
understood that the quality of one’s
psychosomatic life cannot be guaranteed
by pharmacological treatments, it has been
proven that states of overwhelming anxiety,
depression or agitation should be and can
be minimized with the help of pharmacology.
Withania somnifera roots (fam.
Solanaceae), known in Sanskrit as Ashwagandha
in combination with Mucuna pruriens seeds
(fam. Papilionaceae) have been evaluated
for the treatment of deppressive illness
in twenty five patients with endogenous
and reactive types of depression. Ashwagandha
and Mucuna were given in a dose of 6 gm
each in the morning and evening with milk
for two months. The severity of depression
and anxiety was evaluated on a self-evaluation
scale at the beginning of study, after one
month and after two months. A statistically
significant (p<0.001) improvement in
depression and anxiety symptoms scores was
noted at the end of the two months. This
included mood elevation and a reported feeling
of well being. At the end of two months
treatment 48% of the patients were "cured",
36% "improved", 8% had "no
improvement" and 8% had a "relapse"
(Singh RH et al. JRAS. 1989; Vol.XI, No.
1: 1-6). Ashwagandha contains steroidal
lactones which are identified as withanolides;
and the extract is standardized for 1.5%
withanolides. Mucuna pruriens seeds contain
L-dopa, a standard biochemical approach
to the management of depression. (Pras,
N. et al., Pharmacy World & Science,
(1993) 15(6):263-8. |
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| 2. Management
of anxiety neurosis |
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Bacopa monniera (fam. Scrophulariaceae)
called Brahmi in Sanskrit, was evaluated
in a 4 week treatment of anxiety neurosis
in 35 patients. Bacopa was administered
in the form of a syrup containing 12 gm
of the crude drug at the level of 15 ml
two times daily. The patients were assessed
on the following clinical parameters anxiety
level (Sinha anxiety scale), adjustement
level (Asthana adjustement scale), mental
fatigue rate (Joshi’s digit cancellation
test) and immediate memory span (Joshi’s
digit retention scale). The mean anxiety
level in patients after 4 weeks of treatment
was 40.70 as compared to its pretreatment
value 49.05 (p<0.05). The mean maladjustement
level in patients after 4 weeks of treatment
was 153.58 which was significantly lower
than its corresponding pretreatment value
166.28 (p<0.01). The mental fatigue rate
determined in total daily work output in
treated patients was 855.8 as compared to
its corresponding pretreatment value 711.15
(p<0.001). The immediate memory span
score was significantly increased from initial
mean value 5.94 to 6.37 after four weeks
of treatment (p<0.01). In addition to
these findings, the four week therapy resulted
in significant decrease in the systolic
blood pressure from mean value 117 mm/Hg
to 112 mm/Hg (p<0.05) and the significant
increase in breath holding time from mean
value 35 seconds to 48 seconds (p<0.001)
(Singh RH, Singh L , J Res Ayur Siddha.
1980; 1:133-148). The herb, Bacopa monniera
contains saponin compounds named Bacoside
A and Bacoside B. |
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| 3. Management
of substance abuse problem |
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The multicomponent formula Smoker’s
ReliefÔ originating in Tibetan medicine,
in the form of a 330 mg lozenge, was evaluated
in an open field clinical study in three countries:
the USA, Switzerland and Canada. The study
included 51 adult smokers of both genders,
who stated that they were willing to attempt
to stop smoking with help of the lozenge.
A minimum of 9 lozenges per day were taken.
The blend of herbs in this formula has been
known since the historical time of "opium
wars", when it was used to replace the
craving for cigarettes, and to produce a sensory
incompatibility between the taste of smoke
and the blend of herbs. Of the 51 participants
a total of 34 completed the test successfully
either by quitting smoking or reducing the
number of cigarettes smoked per day. Of those
who completed test successfully 22 quit smoking,
and of these 15 were still not smoking when
they were interviewed four months after the
date they quit smoking (Badmaev, V. unpublished
data, 1997). |
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| III.
Pulmonary medicine - clinical and in vitro trials |
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| 1. Treatment
of bronchial asthma |
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In an analogous
way to the digestive tract delivering nutrients,
air passages deliver the most important
nutrient of all - oxygen. In fact, the main
Ayurvedic formula for better delivery of
nutrients at the gastrointestinal level
is used in bronchopulmonary conditions as
well.
Piper longum or long pepper
traditionally known in Sanskrit as Pippali
(fam. Piperaceae), has been used in Ayurveda
and related Unani medicine in the prevention
and treatment of bronchial asthma. In a
study involving 20 children, 5 to 12 years
old, suffering from bronchial asthma with
confirmed sensitivity to house dust mite
(HDM), long pepper fruits were administered
in form of 150 mg (children 5 years old
or younger) or 250 mg (children 5 to 12
years old) capsules for five weeks (week
1-1capsule a day, week 2-2, week 3-3, week
4-2, week 5-1). At the end of 5 weeks all
patients showed significant clinical improvement
as assessed by the pulmonary functions tests
and decrease in frequency and severity of
asthma attacks and decreased sensitivity
to HDM skin test. The FVC , FEV1 and MMEFR
values were significantly (p <0.05) increased:
1.2253 (before treatment)/1.5123(after);
852.17/1061; 48.88/73.38 respectively. The
follow-up of the patients status after one
year found 11 patients with no recurrence
of asthma attacks, 3 with moderate improvement,
3 with no improvement and 3 unavailable
for the follow-up evaluation. (Dahanukar
AS et al. Ind Drugs. June 1984: 384-388).
Piper longum contains a minimum of 1% of
alkaloid piperine, however other yet to
be identified components may be responsible
for the therapeutic action in patients with
asthma.
Another important example of
an Ayurvedic herb used in respiratory conditions
is Tylophora indica (asthmatica) Sanskrit
named Anthrapachaka (fam. Asclepiadaceae).
Tylophora asthmatica was tested in a 12
week double-blind study in 110 patients
with bronchial asthma. The diagnosis of
asthma was based on a history of recurrent
paroxysmal attacks of dyspnea at rest relieved
by epinephrine or ephedrine. The patients
were randomly assigned active treatment,
one leaf of Tylophora a day for six days
to be chewed and swallowed early in the
morning, and matched placebo consisting
of spinach leaf. The patient status was
evaluated based on the interview and physical
examination of a patient. Of the 53 patients
receiving active treatment 33 (62%) improved
by the end of first week, as compared to
16 (28%) out of 57 patients improved on
placebo. At four weeks follow-up the respective
figures were 37% and 11%; at 8 weeks, 30%
and 7.4%; and at 12 weeks, 16% and 0%. The
incidence of side effects such as sore throat,
loss of taste for salt, and/or morning nausea
and vomiting was 53% in the active treatment
group and 9% in the placebo group. ( Shivpuri
DN et al. J Allergy. March 1969:145-150).
Tylophora indica contains alkaloid tylophorine;
standardized extract contains approximately
0.1% of tylophorine.
Ledretan a multicomponent formula
of Tibetan origin was tested in vitro with
the MDCK epithelial tissue culture cell
line for its traditionally recognized anti-viral
effect, particularly in the treatment of
upper-respiratory viral conditions. Specifically
it was tested for its protective activity
against cytopathic effects caused by influenza
A virus. The whole formula and its 23 individual
components were tested in the same system.
The results indicate that the formula is
active in protecting epithelial cells against
damage caused by influenza virus. One of
the most active components in anti-flu activity
of Ledretan was shown to be Terminalia chebulae,
fam. Combretaceae. The whole formula, however,
was more effective than the individual herbs
(Badmaev, V. unpublished data, 1997). |
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| IV. Cardiology
- clinical trials |
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| 1. Management
of cardiovascular disease |
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Combination of
Inula racemosa (fam. Compositae) and Commiphora
mukul (fam. Burseraceae) gum or gugulipid
was evaluated in a 6 months study of patients
with ischemic heart disease. The formula
in form of 500 mg tablets was administered
in a total daily dose of 6 to 8 gm to patients
presenting with precordial pain, dyspnea
and laboratory data indicating elevated
cholesterol and triglycerides. The treatment
resulted improvement of precordial pain
in 150 patients, elimination of the pain
in 50 patients, improvement in dyspnea in
90 patients and elimination of dyspnea in
110 patients. The mean value of blood cholesterol
decreased from 308 mg/dl prior to the treatment
to 188.92 after the treatment (38.6% reduction;
p<0.001). The mean triglyceride levels
of 150.95 mg/dl decreased to 74.48 (50.7%
reduction; p<0.001). The treatment also
resulted in a improvement of the ECG pattern
in 170 patients (Singh RP et al. Int J Pharmacognosy.
1993; 31(2):147-160). Inula contains alantolactone
and isoalantolactone; gugulipid cantains
guggulsterones; standardized extract contains
2.5 to 3.5 % guggulsterones.
The formula of Badmaev 28 is
one of the best clinically tested traditional
multicomponent formulations known. The other
formula’s name Padma was derived from
the family name of Badma or Padma (Russicized
to Badmaev), both names stand for Sanskrit
name of the plant of lotus. The formula
has been developed by five generations of
physicians in Badmaev family and it is rooted
in principles of Tibetan medicine. The usefulness
of the formula in the treatment of peripheral
vascular disease (PVD) was first clinically
evaluated by Hurlimann in late 1970’s
(Schweiz Rundsch Med 1979; 67: 1407-1409).
Subsequently four double blind trials of
the formula in PVD have followed (Schweiz
Med Wochenschr. 1985; 115: 752-756; Angiology
1993; 44: 863-867; Alt Ther Health Med 1995;
1(3): 44-49). In the 12 week study done
by Hurlimann the formula administered up
to 6 tablets (each tablet 500 mg) a day
increased pain free walking distance in
PVD patients by 54% . The clinical research
that followed indicated that the 16 week
regimen resulted in further increase of
pain free walking distance by 93% to 112%.
By comparison known synthetic drugs studied
in PVD patients, e.g. Pentoxifylline (Surgery
1982; 92: 966) and Neftidrofuryl (Med Welt
1979; 30: 269-272) were able to increase
the pain free walking distance by 58% in
a 24 weeks study and by 70% in a 24 weeks
study respectively. |
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| V. Chronic
inflammatory disorders - clinical trials |
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| 1. Management
of arthritis |
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Management of
chronic and debilitating disorders, such
as various forms of arthritis, is a forte
of Ayurvedic therapy. Curcuma longa (or
turmeric fam. Zingiberaceae), Boswellia
serrata (fam. Burseraceae) and Ashwagandha
are often used alone or in combination in
the treatment of chronic, degenerative diseases,
like rheumatoid arthritis and osteoarthritis.
An ingredient obtained from
Curcuma longa or turmeric (fam. Zingiberaceae)
curcumin was evaluated vs. phenylbutazone
in a double-blind 2 week study of 18 patients
with rheumatoid arthritis. Total daily dose
of phenylbutazone was 300 mg and the curcumin
1200 mg, administered in three divided doses.
The following clinical parameters were significantly
improved as a result of tretament with curcumin
or phenylbutazone respectivelly: morning
stiffness (minutes) 132.5 (baseline value)/124.2/97.2
(p<0.05); walking time (sec/25 ft) 15.4/13.8/12.4
(p<0.05); fatigue time (h) 3.8/3.9/5.4
(p<0.05 only for phenylbutazone); swelling
16.8/12.5/11.2 (p <0.02). Grip strength,
articular index and the lab data of inflammatory
proces i.e. erythrocyte sedimentation rate
(ESR) were unchanged. The objective evaluation
of treated patients mean score was 3.4 for
curcumin (p < 0.05), 3.1 for phenylbutazone
(p < 0.001) as compared to the 3.8 baseline
value. In conclusion authors of the study
found that both curcumin and phenylbutazone
showed a comparable antirheumatic acitivity
(Deodhar SD et al. Ind J Med Res. April
1980; 71: 638-634). Curcuma longa contains
curcuminoids, i.e. curcumin, demethoxy curcumin,
bisdemethoxy curcumin.
Boswellia serrata gum (fam.
Burseraceae) in form of a standardized extract
of boswellic acids was tested in a 4 week
double blind, cross-over trial in 30 patients
suffering from rheumatoid arthritis. Boswellic
acids were administered orally in a dose
of 200 mg three times a day, and the control
group received a matching placebo containing
lactose. The mean arthritic score in the
group receiving boswellic acids came down
after four weeks from the pretreatment mean
value of 238.4 to 94.67 ; the mean ESR value
was reduced from 65.93 to 49.2. As a result
of substituting boswellic acids with a placebo
(cross-over), the arthritic score rose again
after four weeks of the regimen from mean
value 125.6 to 181.06; the ESR increased
from 38.06 to 45.13. Two patients reported
a minor skin reaction in the course of treatment
with boswellic acids. For the first 10 to
14 days, the patients needed an additional
analgesic to alleviate the pain (Annual
Report, Regional Research Laboratory, Jammu,
India (1987-1988): 1-2).
In a double-blind, cross-over
3 months study the combination of ashwagandha,
turmeric, boswellia gum and zinc complex
was evaluated in the treatment of rheumatoid
arthritis. Twenty patients suffering from
rheumatoid arthritis randomly received either
two 650 mg capsules of an active formula
every eight hours or the matching placebo.
Each treatment was given for a period of
three months and then after a wash-out period
of two weeks the regimens were crossed-over.
The 3 months active therapy resulted in
significant, decrease in severity of mean
pain score 1.06 vs. 2.76 (p<0.01); morning
stiffness mean score 17.57 vs. 34.2 (p<0.01);
Joint mean score 1.93 vs. 4.17 (p<0.01);
Ritche articular mean index 4.96 vs. 8.86
(p<0.01); grip strength mean score (mm
Hg) 57.59 vs. 33.07 (P<0.01); disability
mean score 0.76 vs. 2.13 (p<0.01). ESR
mean value 20.67 vs. 35.13 as compared to
placebo group. The active treatment group
had one patient complaining of nausea, one
had dermatitis, and four experienced pain
in abdomen. However these side effects did
not necessitate discontinuation fo therapy.
The active treatment group had three patients
and the placebo group had 18 patients who
required NSAIDs to alleviate the pain (Kulkarni
RR et al. Ind J Pharmacol. 1992; 24:98-101).
A compound extracted from Capsicum
annum, capsaicin was evaluated in a 4 week
double-blind study for topical treatment
of pain associated with rheumatoid arthritis
or osteoarthritis. Topical capsaicin 0.075%
or placebo cream was given to 21 patients
to be rubbed into a painful spot four times
a day. Clinical reevaluation of the condition
was done 1, 2 and 4 weeks after the initiation
of the therapy. As compared to the control
group capsaicin significantly reduced tenderness
(p<0.02) and pain (p<0.02) associated
with osteoarthritis but not rheumatoid arthritis.
A local burning sensation was the only adverse
effect noted in the course of the 4 week
treatment with topical capsaicin. One patient
dropped out from the study after 5 days
of the active treatment due to experiencing
a burning sensation. (McCarthy GM, McCarthy
DJ. J Rheumatol. 1992;19:604-607). Natural
(but not synthetic) capsaicin is recognized
by FDA for topical treatment of pain.
The multicomponent anti-inflammatory
formula of Tibetan origin TriPrinâ
, combining herbs and minerals with willow
bark or acetylsalicylic acid, was tested
for the anti-oxidant effects in vitro against
acetylsalicylic acid, or aspirin alone,
and vitamin C. This study showed that the
herbal blend, TriPrin, has anti-oxidant
properties comparable in strength to vitamin
C, while aspirin alone did not have anti-oxidant
effects (Badmaev, V. unpublished data, 1997). |
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| VI. Metabolic
disorders - clinical trials |
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| 1. Diabetes |
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One
of the most debilitating chronic disease
is diabetes, which name came from the Greek
"diabainein" meaning "to
pass through". Two main types of diabetes
are distinguished in literature, i.e. Type
I, also called juvenile diabetes or insulin
diabetes, which occurs due to the lack of
insulin production by the pancreas. Type
II, also known as adult onset or non-insulin
dependent diabetes attributed due to loss
of the insulin receptors in the body tissues.
Diabetes is listed as the leading cause
of noncongenital blindness and kidney failure
among adults 20 to 70 years of age. Diabetes
also leads to accelerated atherosclerosis,
which increases risk of heart disease, stroke
and peripheral vascular disease (PVD). The
latter condition leads to frequent gangrenous
changes of lower extremities in diabetics,
which necessisate surgical amputation.
The extract
from the leaves of Gymnema sylvestre
or Asclepias germinata (fam. Asclepiadaceae)
also named GS4 has been used
in controlling hyperglycemia in 27 patients
presenting with Type I diabetes (insulin-dependent).
GS4 in capsules in a daily dose
of 400 mg was administered for up to 30
months along with daily insulin injections.
They were compared to 37 controls on insulin
therapy alone. The combined therapy, as
compared to insulin alone regimen, resulted
in a significant reduction in blood glucose,
reduction in the insulin dose to nearly
half of the initial amount, reduction in
levels of glycosylated hemoglobin, glycosylated
plasma proteins and reduction of serum lipids
(Shanmugasundaram E.R.B. et al. J Ethnopharm.
1990; 30:281-294). GS4 contains
gymnemic acids standardized for 25 to 75%
content in the extract.
The aqueous
extract of Momordica charantia (fam.Cucurbitaceae)
fruits was evaluated in seven patients with
adult onset diabetes in a 7 week open trial.
The aqueous extract was obtained as a decoction
from 100 gm of the fruit administered once
a day to the patients. The blood glucose
in the patients prior to the treatment was
422, 236, 380, 280, 380, 450 and 250 mg%.
After seven weeks of the treatment the blood
glucose was reduced to 97, 99, 118, 120
(4 weeks), 150 (4 weeks), 100 and 115 mg%
respectivelly. All patients at the onset
of the trial tested positive for the urinary
sugar. Starting at 4 weeks after commencement
of the treatment all patients tested negative
for the urinary sugar. Glycosylated hemoglobin
levels, a useful parameter in the management
and prognosis of diabetes, were evaluated
before and after the treatment. The baseline
mean value of glycosylated hemoglobin was
8.37 mg% and after 7 weeks the mean value
significantly decreased to 6.95 mg% (p<0.01)
(Srivastava, Y. et al. Phytotherapy
Res. 1993;7(4):285-289). A polypeptide
structure called polypeptide-P and resembling
in its structure bovine insulin was isolated
from seeds of the Momordica fruit.
This structure may play a role in hypoglycemic
properties of Momordica. |
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| 2. Treatment
of obesity |
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Ayurvedic
medicine considers excessive body weight
as a result of many causes. Thus the recommended
therapeutic approach includes lifestyle
and nutritional modification as well as
pharmacological treatment. Weight loss therapy
in Ayurveda is seen, not in terms of aesthetics,
but as part of the approach to general well-being.
The treatment usually includes tuning the
gastrointestinal functions to optimize nutrient
digestion and absorption. Improvement in
nutrient delivery, balances food cravings
and increases lean body mass.
The traditional
formula containing Commiphora mukul
(fam. Burseraceae) gum or gugulipid, and
triphala was tested against placebo in a
3 months weight loss study. The placebo
and three varieties of the Ayurvedic weight
loss formula were randomly assigned to 70
non-dieting patients to be taken three times
daily before meals. On average patients
receiving placebo lost 5.3 lbs vs. 18, 17.4
and 17.6 lbs of body weight shed in course
of 3 months treatment with various proportions
of gugulipid and triphala. In addition to
weight loss the treated patients benefited
from lowering blood cholesterol: 10 mg/dl
(placebo), 20 mg/dl, 19 mg/dl and 15 mg/dl
in the respective groups receiving active
treatments. Few patients on active treatment
reported side effects including nausea and
mild diarrhea ( Paranjpe P et al. J.
Ethnopharmacol. 1990; 29(1): 1-11).
Triphala contains gallotanic acids; standardized
extract contains 40% gallotanic acids.
An extract
from Garcinia gambogia (fam. Clusiaceae)
in form of a compound formula containing
400 mg of calcium salt of hydroxycitric
acid (Citrin® in Citrisan®
product) was tested in a double blind weight
loss study on 60 patients. The hydroxycitric
acid formula or an identical placebo capsules
were administered three times daily half
an hour before meals. All patients were
on a low fat diet of 1200 kcal/ day and
were instructed to exercise 3 times per
week. The mean weight reduction in the active
treatment group was 14.11 lbs, while the
patients in placebo group reduced their
weight by 8.37 lbs (p<0.001). The near
infrared light (NIR) technique for evaluating
the body composition determined that 87%
of the weight loss in the active treatment
group was due to fat loss, while the corresponding
figure in the placebo group was 80%. Blood
pressure, total blood cholesterol levels
and waist hip ratio were statistically significantly
reduced as a result of the active treatment
(P<0.001). The appetite score using the
visual analog scale was significantly reduced
in the active treatment group as compared
to the placebo group (p<0.001). Two patients
dropped out of the study due to gastrointestinal
discomfort, one in the active and one in
the placebo group ( Thom E., Int J Obesity.
May 1996;20(4): abstract). |
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Practical
applications of these studies |
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It
is heartening to note that several of the traditional
approaches from Ayurveda and Tibetan Medicine
offer safe and effective means for managing a
number of common disorders, as supported by extensive
clinical documentation. There is hope that a number
of disease conditions that would conventionally
require treatment with debilitating drugs over
prolonged periods of time, can be treated more
safely and effectively using combination therapies
with herbs from the ancient materia medica. Incidence
of diseases such as diabetes has increased sixfold
in the U.S. in recent years, from 1.6 million
cases in 1958 to 10 million in 1997 (USA Today,
Oct. 31-Nov. 2 1997). In such instances, there
is scope for the use of standardized extracts
of Ayurvedic herbs such as Momordica charantia
and Gymnema sylvestre alone or along with conventional
therapies, in the management of the disease and
to protect the patients from its secondary complications.
Similarly, herbs such as Withania somnifera, Mucuna
pruriens, Bacopa monniera could be used in the
management of psychosomatic disorders such as
anxiety neurosis and mental depression which are
becoming increasingly significant in the US. With
reference to over-the-counter drugs such as antacids,
weight loss products and laxatives, there have
been increasing reports of undesirable side effects
in several cases. Alternative Ayurvedic/Indo-Tibetan
approaches would be relevant in this context providing
both safety and efficacy.
It should be kept in mind, however,
that Ayurveda and Tibetan medicine offer much
more than a "pill". These systems provide
a sound heath care philosophy. In their unique
approach, none of the techniques devised by humans
against disease could be as helpful as an individual’s
own means of fighting the disease. Specific treatments
are directed towards supporting these efforts
during critical moments. However, primarily, the
patient should be maintained in good shape by
proper nutrition, good living habits, adequate
adjustment to seasonal changes and self awareness
of his/her physical and psychological predispositions.
Contemporary medical practice could benefit from
the inclusion of the materia medica and health
care philosophy inherent in these ancient systems
in the management of disease conditions. |
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