Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial.
ABSTRACT 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.
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.
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.
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.
Policosanol does not alter the serum lipid profile over an 8-wk period in adults with mild hypercholesterolemia.
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ABSTRACT: Policosanols (PC) are very long chain aliphatic alcohols derived from the wax constituent of plants. In the early 1990s, researchers at Dalmer Laboratories in La Habana Cuba isolated and produced the first PC supplement from sugarcane wax. The original PC supplement has been approved as a cholesterol-lowering drug in over 25 countries throughout the Caribbean and South America. Cuban studies claim that 1 to 20 mg/day of the original PC supplement are effective at producing significant reductions in total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C). These studies also show that PC supplements are potent antioxidants, promote proper arterial endothelial cell function, inhibit platelet aggregation and thrombosis, and serve as effective treatments for intermittent claudication. However, for the most part, those studies reporting therapeutic efficacy of PC were carried out by one research group situated in Cuba. Conversely, research groups outside of Cuba have failed to validate the cholesterol-lowering and antioxidant efficacy of PC. Cuban researchers, however, continue to claim that the efficacy is attributed to the unique purity and composition of the original PC preparation, a mixture not found in PC products used by external research groups. The absence of independent and external studies confirming the therapeutic benefits of PC in disease prevention and treatment raises questions regarding their true efficacy.Critical reviews in food science and nutrition 03/2010; 50(3):259-67. DOI:10.1080/10408391003626249 · 5.55 Impact Factor
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ABSTRACT: The prevention of cardiovascular risk, as occurs in lipoprotein disorders, is required since childhood. Aim of the study was to evaluate, in a group of children affected by primary dyslipidemia, the efficacy, tolerability and safety of a short-term treatment with a dietary supplement containing red yeast rice extract and policosanols. 40 children affected by heterozygous Familial Hypercholesterolemia (FH) (n=24) and Familial Combined Hyperlipidemia (FCH) (n=16), aged 8-16 years, were enrolled in a double-blind, randomized, placebo-controlled, cross-over trial. After a 4-week run-in period with only dietary advice, children received a dietary supplement containing 200mg red yeast rice extract, corresponding to 3mg of monacolins, and 10mg policosanols once-daily and placebo for 8 weeks, separated by a 4-week washout period. Lipid profile was assessed after each treatment period. The dietary supplement, compared with the placebo, significantly reduced total cholesterol by 18.5% (p<0.001), LDL-C levels by 25.1% (p<0.001), and apolipoprotein B by 25.3% (p<0.001) when patients were considered as a whole group. Similar results were obtained when FH and FCH were considered separately and no significant difference between groups was detected. No significant differences were observed in HDL-C and apolipoprotein A-I levels. No adverse effects were detected when liver and muscular enzymes (AST, ALT, and CK) were determined. The treatment with a dietary supplement containing red yeast rice extract and policosanols has been for the first time successfully employed in hypercholesterolemic children. Results indicate this strategy as an effective, safe and well tolerated in a short-term trial.Nutrition, metabolism, and cardiovascular diseases: NMCD 02/2010; 21(6):424-9. DOI:10.1016/j.numecd.2009.10.015 · 3.88 Impact Factor
- Applied Physiology Nutrition and Metabolism 03/2009; 34(1):76-7. DOI:10.1139/h08-140 · 2.23 Impact Factor