PISCATAWAY NJ - Sabinsa Corporation today questioned the lack of balance demonstrated by the Journal of the American Medical Association (JAMA) in reporting results of current research on the potential cardiovascular benefits of the company's branded gum guggal extract, Gugulipid®. In an article scheduled to appear in the August 13, 2003 issue, JAMA represents 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)."
The modern history of gum guggal started in the 1960's when the gum began to be systematically studied for its potential in the treatment of elevated blood cholesterol. The safety profile, pre-clinical and clinical trials were done in India during the 1980's at the Central Drug Research Institute (CDRI), Lucknow, India. There are nine published human clinical trials evaluating the hypolipidemic effect of guggal extracts. However, only five studies used a standardized guggal extract, only two of these were randomized, and only one was placebo-controlled.
Badmeav continues, "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."
Muhammed Majeed, PhD, founder and CEO of Sabinsa Corporation concludes, "We were pleased to partner with NIH in this important study. We know of no other 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."
Sabinsa Corporation is an application-oriented manufacturing and marketing company which manufacturers and supplies Phytonutrients, Nutraceutical herbal extracts and specialty fine chemicals used for nutritional, pharmaceutical and food products. Sabinsa distinguishes itself by its extensive research support for its customers and products, and the scientific credentials of its key technical staff.
Please contact Sabinsa Corporation for more information in New Jersey at (732) 777-1111 or in Utah at (801) 465-8400.
Gugulipid® is a registered trademark of Sabinsa Corporation.