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A Randomized Controlled Trial

Heiner K. Berthold, MD, PhD; Susanne Unverdorben, MD; Ralf Degenhardt, PhD; Michael Bulitta, Dipl-Stat; Ioanna Gouni-Berthold, MD

JAMA. 2006;295:2262-2269.

Context  Policosanol is a natural substance derived from sugar cane that is advertised for its lipid-lowering effects as a nonprescription drug. More than 80 placebo-controlled or comparative trials, performed mostly by a single research institute, suggest that policosanol at doses of 5 to 40 mg/d has lipoprotein-lowering effects comparable with statins.

Objectives  To determine the lipoprotein-lowering effects of Cuban sugar cane–derived policosanol and to establish, if effective, dose-dependency up to 80 mg/d in patients with hypercholesterolemia or combined hyperlipidemia.

Design, Setting, and Participants  A multicenter (lipid outpatient clinics and general practitioners in Germany), randomized, double-blind, placebo-controlled, parallel-group trial conducted from September 29, 2000, to May 10, 2001, of patients with hypercholesterolemia or combined hyperlipidemia having baseline low-density lipoprotein cholesterol (LDL-C) levels of at least 150 mg/dL (3.88 mmol/L) 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 (3.88-4.89 mmol/L) and 2 or more risk factors.

Interventions  Open-label 6-week placebo and diet run-in phase followed by a double-blind 12-week treatment phase after randomization to 5 groups: 10, 20, 40, or 80 mg/d of policosanol or placebo.

Main Outcome Measure  The percentage change of LDL-C, with changes in other lipoproteins as secondary outcome measures.

Results  A total of 143 patients were randomized to 5 equal groups and were analyzed on an intention-to-treat basis. In none of the 5 treatment groups did LDL-C levels decrease more than 10% from baseline. No statistically significant difference between policosanol and placebo was observed. A nonparametric test analyzing dose-dependency yielded nonsignificant results. In none of the secondary outcome measures, namely total cholesterol, high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, triglycerides, lipoprotein(a), and ratio of total or LDL-C to HDL-C, were there any significant effects of policosanol. Policosanol was tolerated well without serious adverse events.

Conclusion  In patients with hypercholesterolemia or combined hyperlipidemia, the sugar cane–derived policosanol in usual and high doses does not demonstrate a reduction in lipid levels beyond placebo.

Trial Registration  clinicaltrials.gov Identifier: NCT00288483

Author Affiliations: Department of Clinical Pharmacology, Institute for Clinical Research, Center for Cardiovascular Diseases, Rotenburg an der Fulda (Drs Berthold, Unverdorben, and Degenhardt), Clinical Research Management Pharmaberatung GmbH, Rheinbach (Mr Bulitta), and Department of Internal Medicine II, University of Cologne, Cologne (Dr Gouni-Berthold), Germany.

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