AYURVEDIC MEDICINE: Scientific Updates

  Gugulipid


    A Lipid Lowering Botanical Derived from
    Ayurvedic Traditon


     by Vladimir Badmaev,M.D., Ph.D. and Muhammed Majeed, Ph.D.

When it comes to discussing the levels of healthy cholesterol there is much more to consider than a single number.  Currently, concern is not necessarily just with cholesterol per se, but with its various fractions, popularly referred to as 'good', 'bad', 'ugly' and 'deadly'.  While 'good' or high density lipoproteins (HDL) and 'bad' or low density lipoproteins (LDL) are relatively well known terms, the lesser known and newer additions to the cholesterol family include 'ugly' (triglycerides) and 'deadly' (lipoprotein a).  The latter is obviously disturbing, particularly since it can be written into our genes, and when elevated it is responsible for a very high rate of cardiovascular disease at a very young age.  This compounding knowledge of cholesterols, and the growing awareness of related atherosclerosis and cardiovascular disease -still the number one cause of mortality in modern society - compet us to seek safer and more effective preventive and therapeutic solutions to this staggering health problem.

It is a sobering experience to consider that cardiovascular disease has been afflicting our civilization for centuries.  Atherosclerosis and its resulting cardiovascular disease were understood in principle and well documented some 2000 years ago.  The Ayurvedic medical treatises of Charka Samhita (1000 BC), Sushruta Samhita (600 BC), Vagbhata (7 th century AD) and Nighantusa (12 th - 14 th century AD) refer to detrimental health conditions that may result from unbalanced nutrition and a sedentary life style.   These two factors were reported to contribute to a 'coating and obstruction of channels', which translates into contemporary terminology as atheromatous changes (fatty streaks) in the blood vessels.  To counteract this process, Ayurvedic practitioners have prescribed an amber-like resin that oozes from incisions made in the bark of the Commiphora mukul (N.O. Burseraceae) tree, and commonly known as gum guggul.

In the 1960's, the oleogum resin (gum guggul) was systematically studied for its potential in the treatment of elevated blood cholesterol, or hyperlipidemia.    This research originated at the College of Medical Sciences of the Banaras Hindu University in Varanasi, India, and was continued in the 1980's at the Central Drug Institute (CDRI) in Lucknow, India.  The structure function analysis of gum guggul has determined that  the ethyl acetate soluble portion of the gum, specifically its neutral portion, contains most of the hypolipidemic properties.  The neutral fraction was found to be a source of sterol compounds known as guggulsterone E and Z (pregname derivatives) which are responsible for the lowering of blood cholesterol.    Subsequently, a preparation of gum guggul used by the CDRI in clinical studies consisted of an extract solid, standardized to contain a minimum 2.5% guggulsterones E and Z.

These studies on gum guggul indicate that its hypolipidemic activity could be attributed to more than one mechanism, i.e. sequestration of bile acids leading to enhanced excretion of cholesterol, inhibition of cholesterol biosynthesis, degradation of cholesterol by increased activity of the thyroid hormones, and alteration in catecholamine levels.  Gum guggul may further reduce the risk of cardiovascular disease by inhibition of platelet aggregation, increases in fibrinolytic activity and as a result of its antiinflammatory and antioxidant properties.

The previously mentioned work done by CDRI resulted in the first clinically tested gum guggul product. Gugulipid, a standardized extract of gum guggul was the subject of the study.  Phase 1 evaluated safety of the extract given in a dose of 400 mg tid for four weeks to 21 hyperlipidemic patients.  This regimen was well tolerated with no subjective or objective side effects reported.  In phase 11, the efficacy of the extract at a dose of 500 mg tid for 12 weeks was evaluated on 19 patients with hyperlipidemia and a history of cardiovascular disease.  Gum guggul significantly lowered serum cholesterol and triglycerides in 78% (15 subjects) of the cases.  On average, cholesterol was lowered by 17.3% and triglycerides by 30.3%, and the positive changes in blood lipids were noticeable starting in week four of the therapy.

Subsequently a multicenter, phase III, clinical trial was organized by CDRI on 245 patients with dyslipidemia.  Eighty percent of the subjects responded positively to the treatment. 

This therapeutic effect was independent of age, sex or body weight, and the treatment was found especially useful in cases with total cholesterol levels of 220 mg/dl or higher and triglycerides of 170 mg/dl or higher.

Overall, four published clinical trials were done with this standardized gum guggul preparation.  Two of the four studies were placebo controlled, and one study compared the hypocholesterolemic action of gum guggul with a similar purpose drug, clofibrate.  A typical dose in those clinical studies consisted of 25 mg of guggulsterones E and Z administered  orally three times a day.  When results of the four clinical studies were pooled it was shown that on average 70% of the patients enrolled lowered both their total cholesterol and triglycerides in response to the treatment.   An additional benefit of the gum guggul treatment was the marked elevation of 'good' cholesterol or HDL ranging from a 20-36 % increase.

Although a standardized gum guggul preparation has never been directly compared to statins (commonly used cholesterol lowering prescription drugs), it appears to reduce 'bad' cholesterol LDL on average by 17%, which is comparable to results obtained with 20mg of fluvastatin or 10 mg of pravastatin.  Gum guggul also increased HDL by 14%, which is similar to the results obtained with 1200 mg of gemfibrozil, and reduced triglycerides by 24%, a result comparable to treatment with 2 gm of niacin.

It should be noted that major advantage of a properly standardized gum guggul preparation over currently available drugs is a relative lack of adverse effects.    Most statins can cause liver damage and gastrointestinal discomfort. Cholestyramine produces constipation, abdominal discomfort, bleeding tendencies and poor absorption of fat-soluble vitamins.  Clofibrate can cause liver damage, gastrointestinal discomfort and headaches.

Proper standardization of gum guggul is essential to the safety and efficacy of the preparation.  In clinical studies, the administration of crude (unpurified) guggul caused mild side effects such as skin rashes, diarrhea and irregular menstruation.    The methods of standardization used by Sabinsa in its Gugulipid brand of gum guggul assure that potentially harmful compounds are removed. In a powder, Gugulipid is standardized to contain a minimum 2.5% guggulsterones E and Z and quantified by HPLC analysis.  In a standardized soft extract, the minimum is 7.5% gugulsterones E and Z.

The fact that the gum resin of Commiphora mukul comes with an exceptionally long history   of use, systematic safety and clinical studies points to its increasing importance as the nutraceutical of choice in lowering blood lipids and the risk of cardiovascular disease.

Gugulipid is a registered trademark of Sabinsa Corporation

References available at request.

Vladimir Badmaev, M.D., Ph.D. is trained in clinical and anatomical pathology at kings county Hospital and Downstate Medical Center, New York.  His Ph.D. degree is in the field ofimmunopharmacology.   He is the author of many articles and book on traditional medicine, with an emphasis on Ayurvedic and Tibetan medicine.  He is Sabinsa's Vice President of Scientific and Medical Affairs.

Muhammed Majeed, Ph.D. holds a doctorate in industrial pharmacy from St. John's University in New York.  He has over 15 years of pharmaceutical research experience in the US with leading companies such as Pfizer, Inc., Carter-Wallace, and Paco Research.  Dr. Majeed has a broad knowledge of the pharmacological properties of herbal medicines used in Ayurveda, the traditional system of botanical medicine of India.  He is Sabinsa's President and CEO.

 

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