JAMA Critical of Herbal Product, Sabinsa and Pharmavite Respond

This week's Journal of the American Medical Association has created a stir in several communities.

According to a press release issued by the Journal, research published in the August 13th JAMA indicated 'HERBAL EXTRACT NOT EFFECTIVE IN TREATING HIGH CHOLESTEROL'. The extract in question was guggul, more specifically, Guggulipid, a product supplied by study contributor Sabinsa Corp., and in the following text, the press release suggested that not only did the product not improve cholesterol levels over the short term, it may have even raised LDL (bad cholesterol) levels.

The balance of the press release describes the study results, indicating 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 guggulipid. The release notes that six participants responded to the course of treatment with hypersensitivity rashes, and in their response to the JAMA release, Sabinsa ackowledges that this observation is consistent with known data and that Sabinsa is working on identifying the skin sensitizing compounds through further clinical work.

JAMA ackowledges 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."

In the release conclusion, the authors make several sweeping comments about 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."

Sabinsa has responded to the JAMA release with a statement questioning its lack of balance in presenting the study highlights:


stating that "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." Sabinsa contends that there are cholesterol lowering drugs which also increase LDL, while lowering other lipids and that there are other cholesterol indicators receiving current attention in addition to LDL including "C-reactive protein (CRP), as well as levels of uric acid and lipoprotein(a)." Regrding the safety of the compound, Sabinsa cites nine studies in India, ackowledging that five used a standardized extract, two were randomized and one was placebo-controlled.

Further on the subject, obviously fearing that the negative association between natural options and efficacy in cholesterol management may spread to other products, Pharmavite LLC has issued a release entitled 'Natural Phytosterols and Phytostanols Clinically Proven to Reduce Cholesterol; A New JAMA Study May Mislead Consumers Into Thinking All Natural Options Are Ineffective'. Pharmavite notes that the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have recently recognized the ability of certain plant-based products, called phytosterols and phytostanols, to reduce cholesterol levels.

Given past history, this fear is likely legitimate. Also, given precedent, the JAMA release, with the slant of its title, will get signiicantly more exposure than the Sabinsa response, or the Pharmavite clarification. And in an area where it matters quite a bit, with practitioners, some new generalizations will occur, as momentum within this community for supplement manufacturers takes another blow. Lost in all of this dialogue will be the efforts of Sabinsa to support their products with appropriate clinical trials.

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