Study indicates widely-used nutritional supplement does not improve cholesterol levels

May 16, 2006

A new study suggests that use of the nutritional supplement policosanol does not lower cholesterol levels any more than placebo, apparently contradicting the results of previous studies, according to a study in the May 17 issue of JAMA.

Policosanol is a natural substance produced from the waxy coating of sugar cane. Cuban sugar cane policosanol is sold in more than 40 countries mainly because of its supposed lipid-lowering effects, according to background information in the article. Numerous policosanol products from a variety of sources (sugar cane, wheat germ, rice bran, beeswax) are available over-the-counter and on the Internet in several countries. Advertising emphasizes predominantly its reputed lipid-lowering effects, comparable with statins (prescription medications taken to lower cholesterol). Most of the published scientific literature, more than 80 trials, supporting the beneficial effects of policosanol on lipids has been authored by a single research group from Cuba. One clinical trial from the Netherlands showed wheat germ-derived policosanol ineffective in lowering total cholesterol and low-density lipoprotein cholesterol (LDL-C), sometimes called "bad" cholesterol.

Heiner K. Berthold, M.D., Ph.D., of the University of Cologne, Germany, and colleagues conducted a study to determine the lipid-lowering effects of policosanol. The multicenter, randomized, double-blind, placebo-controlled, trial included 143 patients with hypercholesterolemia (high cholesterol) or combined hyperlipidemia (excess of fats or lipids in the blood) having baseline LDL-C levels of at least 150 mg/dL and either no or 1 cardiovascular risk factor other than known coronary heart disease, or baseline LDL-C levels of between 150 and 189 mg/dL and 2 or more risk factors. The patients were randomized into 5 groups: 10, 20, 40, or 80 mg/d of policosanol or placebo. The study was conducted from September 2000 to May 2001.

In none of the 5 treatment groups did LDL-C levels decrease more than 10 percent from baseline. No statistically significant difference between policosanol and placebo was observed. In none of the secondary outcome measures, namely total cholesterol, high-density lipoprotein cholesterol (HDL-C; known as "good" cholesterol), very low-density lipoprotein cholesterol, triglycerides, lipoprotein(a) (a family of lipoprotein particles varying in density and size), and ratio of total or LDL-C to HDL-C, were there any significant effects of policosanol. Policosanol was tolerated well and no severe adverse events occurred.

"Our results suggest that [policosanol] is devoid of clinically relevant lipoprotein-lowering properties in white patients. Still, more independent studies are required to counterbalance the vast body of available positive trials. Although policosanol has been used for more than a decade in clinical trials, there are still no data on patient-related outcomes, such as cardiovascular morbidity and mortality. Moreover, independent information should be given to consumers who might take policosanol to improve their cardiovascular risk profile," the authors conclude.
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(JAMA. 2006;295:2262-2269. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: This study was sponsored by Madaus AG, Cologne, Germany, which also provided funding of the contract research organization involved. Neither Madaus AG nor any of their subsidiary companies manufacturers or distributes any lipid-lowering drugs, including statins.

The JAMA Network Journals

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