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

Carolinas Medical Center Department of Family Medicine, Charlotte, NC, USA.
American Journal of Clinical Nutrition (Impact Factor: 6.77). 01/2007; 84(6):1543-8.
Source: PubMed


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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    • "Its hypolipidemic effect was suggested to act via enhancing the activity of AMPK through phosphorylation and inhibiting HMGR activity in animal model and cell lines (Oliaro-Bosso et al., 2009; Banerjee et al., 2011). But the efficacy is not consistent in human and some animal trials (Dulin et al., 2006; Greyling et al., 2006; Kassis et al., 2007; Francini-Pesenti et al., 2008) thus raising questions regarding its true efficacy (Marinangeli et al., 2010). "
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    ABSTRACT: Hyperlipidemia is one of the major risk factor for the development of cardiovascular disease. Hypolipidemic nutraceuticals and functional foods help improve serum lipid profiles as reducing total cholesterol, triglyceride, and low-density lipoprotein cholesterol, while elevating high-density lipoprotein cholesterol. The effectiveness of omega-3 polyunsaturated fatty acid, phytosterols, dietary fiber, and tea catechin in management of hyperlipidemia has been clearly demonstrated in epidemiological and interventional trials. Studies on mechanism reveal that they act as inhibitor or activator of critical enzyme, agonist or inhibitor of transcription factor, competitor of transporter, and sequestrant of bile acid to modulate lipid homeostasis. Hypolipidemic effects are also claimed in dietary proteins, many polyphenols, other phytochemicals, raw extract, or even whole food. This review attempts to give an overview of lipid homeostasis and summarize recent findings of hypolipidemic nutraceuticals and functional foods according to their active ingredients, focusing on the efficacy and underlying mechanisms.
    Full-text · Article · Feb 2014 · Critical reviews in food science and nutrition
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    • "Most external studies testing PC efficacy, however, did not use sugarcane derived products (Lin et al., 2004; Murphy et al., 2004; Reiner et al., 2005; Y. Wang et al., 2005; Y. W. Wang et al., 2003). If sugarcane PC supplements were used, PC preparations were different from the original product used in Cuban studies (Cubeddu et al., 2006; Dulin et al., 2006; Greyling et al., 2006). "
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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.
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    • "As referred by Reiner et al., policosanols significantly reduced TC, but no significant LDL-C and ApoB change occurred in adults [24]. However, these results were not confirmed by other authors [25] [26] and the effect of policosanols on lipoprotein profile remains controversial. No trials employing these dietary supplements have been performed in children with hypercholesterolemia as far as we know. "
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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.
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