Guggul Less Heart-Healthy Than Suspected?

PHILADELPHIA--Guggul, a previously proven heart-healthy herbal extract, was not shown to benefit subjects with high cholesterol, according to researchers at the University of Pennsylvania School of Medicine. Their study, printed in the Aug. 13 issue of The Journal of the American Medical Association (290, 6:765-72, 2003) (www.jama.com), indicated guggul extracts may actually raise LDL levels.

Researchers from the University of Pennsylvania, Philadelphia, noted while guggul extracts have been widely used in Asia to lower cholesterol, they have not been reviewed for safety or efficacy in Western populations. To determine the safety and efficacy of a standardized guggul extract (as Gugulipid®, containing 2.5-percent guggulsterones, manufactured by Piscataway, N.J.-based Sabinsa Corp.), researchers enrolled 103 ambulatory, community-dwelling, healthy adults who had high blood pressure. For eight weeks, subjects were randomly assigned to receive placebo, a high-dose (three 2,000 mg doses) or low-dose (three 1,000 mg doses) guggul extract daily.

Compared with the placebo group, whose LDL levels decreased by 5 percent, subjects in the high-dose and low-dose groups exhibited 4-percent and 5-percent LDL increases, respectively. None of the subjects exhibited changes in total cholesterol, HDL or triglyceride levels. And, while researchers stated guggul was generally well tolerated, six of the 67 guggul-treated subjects developed a rash from treatment compared to none of the placebo subjects.

Sabinsa Corp. (www.sabinsa.com) commented on the incomplete presentation of the study's results. According to the company, cardiovascular disease is a process of multiple lipid fractions, not only LDL, as well as markers of inflammation (C-reactive protein), levels of uric acid and lipoprotein(a). Additionally, Sabinsa noted nine published human clinical trials have evaluated the cholesterol-lowering effects of guggul extracts, and the company holds a U.S. Patent (#6,436,991) regarding improvement of cardiovascular disease.

"This study did reaffirm the long history of safe use of Gugulipid," said Vladimir Badmaev, M.D., Ph.D., vice president of medical and scientific affairs at Sabinsa. "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."