Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial.

BACKGROUND: Policosanol is one of the fastest growing over-the-counter supplements sold in the United States. The use of policosanol to treat elevated cholesterol is based on clinical trials conducted in Cuba, which showed sugar cane-derived policosanol to be similar in efficacy to statins. Recent studies have challenged these findings, but there have been no trials conducted in North America that have examined the ability of sugar cane-derived policosanol to lower cholesterol. OBJECTIVES: This study investigated the efficacy of sugar cane-derived policosanol in healthy adults with mild hypercholesterolemia. The primary outcome was the percentage change in LDL cholesterol after 8 wk of therapy. Secondary outcome measures included changes in total cholesterol, HDL cholesterol, triacylglycerols, C-reactive protein, and nuclear magnetic resonance-determined lipoprotein profile. Dietary habits, weight, and blood pressure were also monitored. DESIGN: Ambulatory, community-dwelling healthy adults with mild hypercholesterolemia (n = 40) were assigned to receive oral policosanol (20 mg) or placebo once daily for 8 wk. This was a double-blind, randomized controlled trial conducted from January through August 2005. RESULTS: No significant differences in the change in LDL cholesterol were observed between the placebo (n = 20) and policosanol (n = 20) groups. Also, no significant changes in secondary outcome measures, including total cholesterol, HDL cholesterol, triacylglycerol, C-reactive protein, and nuclear magnetic resonance spectroscopy-determined profiles were observed. Policosanol was well tolerated, and no significant adverse events were noted. CONCLUSION: Policosanol does not alter the serum lipid profile over an 8-wk period in adults with mild hypercholesterolemia. Copyright © 2006 American Society for Nutrition [ABSTRACT FROM AUTHOR]