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Long
known in the Ayurvedic tradition as a phytonutrient effective
in supporting cardiovascular health, Gugulipid®
is now a popular dietary supplement. A press release on
the subject provoked much attention from the media, resulting
in negative publicity for this useful herbal ingredient.
A study appearing in the Journal of the American Medical
Association, (JAMA, August 13, 2003) is reported in
the release, to indicate no net effect on total cholesterol,
high-density lipoprotein cholesterol (HDL-C), triglycerides,
or very-low-density lipoprotein cholesterol (VLDL-C)
in response to treatment with Gugulipid®.
An additional observation was that six participants
responded to the course of treatment with hypersensitivity
rashes.
Sabinsa’s response to a press release on this
study as summarized by Dr. Muhammed Majeed, founder
and CEO is as follows:
“Many of you have seen the apparently insufficient
report in JAMA on the Gugulipid®
study. As a result, regrettably, popular media sent
out stereotypical negative reports to the public.
The facts are:
- The study is co-funded by SABINSA Corporation and
the IND No. 59, 712 is in the name of SABINSA Corporation.
- This is only an 8-week study, which may not be enough
time for some pharmacological effects to be determined.
In general, all studies on products like this need
to be done for 3 months or more.
- This is an 8-week safety and preliminary efficacy
study, done for the first time with Gugulipid®
on the American population, which we thought of primary
importance. The same IND is continuing at Our Lady
of Mercy Medical Center, Bronx, NY for a 3-month duration
to further evaluate efficacy.
- Several positive results, including C-reactive protein
(CRP) levels reduction (CRP indicates an inflammatory
process which has been linked recently with cardiovascular
disease) are not included in the JAMA article. Such
information will be published later.
Gugulipid® was pioneered
in the United States by SABINSA. We will continue our
efforts in clinical documentation of this product as
an efficacious cholesterol management nutraceutical.”
The press release from JAMA acknowledges the background,
history and efficacy of guggul:
"Guggul is an extract from the resin of the mukul
myrrh tree, according to background information in the
article. Herbal extracts from guggul have been widely
used in Asia as cholesterol-lowering agents, and their
popularity is increasing in the United States. Recently,
guggulsterones, the purported bioactive compounds of
guggul, have been shown to be potent antagonists of
2 nuclear hormone receptors involved in cholesterol
metabolism, establishing a plausible mechanism of action
for the hypolipidemic (high cholesterol) effects of
these extracts. However, there are currently no published
safety or efficacy data on the use of guggul extracts
in Western populations."
The release further stresses on the need for well-designed
clinical trials to evaluate dietary supplements, and
the fact that "they require clinical trial evidence
of safety before being widely used or recommended."
The press release highlights only a portion of the
results from the study, giving an incomplete representation
of the overall safety and efficacy data that was documented.
Vladimir Badmaev, MD, PhD, Vice President of Medical
and Scientific Affairs for Sabinsa noted, "Cardiovascular
disease is currently seen as a process where multiple
lipid fractions, not only LDL, play an important role.
In fact, there are known cholesterol-lowering drugs
which actually increase LDL, while lowering other important
lipids, like triglycerides. The most recent considerations
in therapy of high cholesterol include indices of inflammation,
e.g. C-reactive protein (CRP), as well as levels of
uric acid and lipoprotein(a)."
Dr. Badmaev further commented that, "This study
did reaffirm the long history of safe use of Gugulipid®.
Side effects communicated to the FDA, in compliance
with the IND study protocol, were in keeping with what
has been previously documented, which is a slight skin
rash in a low number of participants. Sabinsa is undertaking
further clinical study evaluating fractions of Gugulipid®
to identify the potential skin sensitizing components,
which was the only side effect reported. This is all
in an effort to gain better understanding of the product
and further improve the composition of our Gugulipid®."
In the words of Dr. Muhammed Majeed, "We were
pleased to partner with NIH in this important study.
We know of no other dietary ingredient suppliers or
manufacturers making this kind of commitment and investment
in their products. The task of improving a worthy and
safe nutraceutical like Gugulipid®,
is tedious, but in the end rewarding. Our commitment
remains strong. In 2002, we obtained for Gugulipid®
US Patent #6,436,991 which is directed towards the nutritional/nutraceutical
improvement of cardiovascular disease. We have also
initiated a second IND study involving Gugulipid®
in the US, which is scheduled to begin in the fall of
2003."
A
new publication on Gugulipid®
from Sabinsa Corporation detailing the historical
background, traditional use, contemporary research
and clinical studies on this product is now available.
This provides the wealth of clinical documentation
available for this well-researched phytonutrient
from the Ayurvedic tradition. Strong parallels
exist between modern concepts on the etiology
of atherosclerosis and obesity, and descriptions
in the Sushruta Samhita written in the 5th to
4th century B.C. Traditionally, guggul is used
in formulations for the treatment of inflammation,
arthritis, cardiovascular conditions and obesity.
Please contact Sabinsa to
receive a copy of this publication.
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