Clinical Briefs: Policosa — no?
Clinical Briefs: Policosa — no?
With Comments from Russell H. Greenfield, MD. Dr. Greenfield is Medical Director, Carolinas Integrative Health, Carolinas HealthCare System, Charlotte, NC, and Clinical Assistant Professor, School of Medicine, University of North Carolina, Chapel Hill, NC.
Source: Berthold HK, et al. Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: A randomized controlled trial. JAMA 2006;295:2262-2269.
Goal: To assess the lipid-lowering capacity of policosanol in patients with dyslipidemia and, if effective, determine dose dependency.
Design: Randomized, double-blind, placebo-controlled, parallel-group (five), multicenter trial offering 12-week intervention.
Subjects: Patients recruited from German primary care offices and lipid clinics with either hypercholesterolemia or combined hyperlipidemia, and baseline low-density lipoprotein (LDL) ≥ 150 mg/dL with no or only one cardiac risk factor, or baseline LDL between 150-189 mg/dL with two or more risk factors (n = 143, data assessed for n = 129).
Methods: Following an open diet and a six-week placebo run-in, subjects were randomized to one of five groups: placebo or 10, 20, 40, or 80 mg policosanol daily. Fasting blood samples were obtained at baseline, four, five, and six weeks into the run-in phase, and six and 12 weeks into the intervention. Primary outcome to be determined was dose-dependent decrease of LDL with policosanol; secondary outcome measures focused on potential impact on other lipid parameters as well as safety/tolerability.
Results: At weeks 6 and 12 there was a slight decrease in LDL in the active group, but a decrease unlikely to be of clinical relevance (< 10%). No significant dose-dependent effect was identified, nor were significant changes noted for other lipid parameters measured. Policosanol was well tolerated, and no serious adverse effects were noted in either group.
Conclusion: Policosanol appears to be safe but likewise appears ineffective at lowering cholesterol levels in any clinically relevant manner beyond placebo for people with dyslipidemia.
Study strengths: Intention-to-treat analysis; reported compliance; use of policosanol formula employed in most positive trials.
Study weaknesses: Compliance checked by pill count; all subjects were white; relatively short duration.
Of note: The researchers embarked on this trial in part because of a remarkable degree of consistency of positive effect of policosanol in Cuban trials in association with a paucity of data from outside Cuba; results from one Dutch study suggested that 20 mg of policosanol derived from wheat germ was ineffective at lowering cholesterol levels; patients received dietary counseling at baseline and at the end of the run-in phase; potential subjects were excluded if they had known coronary artery disease; 114 subjects received policosanol while 29 were given placebo; compliance with the study protocol was extremely good; diet had no influence on study results.
We knew that: Policosanol is a mixture of alcohols isolated from sugar cane, most often from Cuba, although some products are derived from beeswax and other sources; there are more than 80 published trials assessing the effects of policosanol on high cholesterol levels, the majority noting beneficial effects comparable to those seen with statin drugs, but nearly all the data come from one Cuban research group; to achieve significant reduction in cardiovascular risk profile requires an approximate 30% drop in LDL levels; the usual dose of policosanol recommended to help lower cholesterol is 10-20 mg/d.
Clinical import: As the authors point out, the results of this independent trial are in stark contrast to those published trials suggesting a significant lipid-lowering effect of policosanol. The researchers prudently dance around potential reasons for this discrepancy, and in a balanced appraisal state that more research should be performed (perhaps of longer duration, even though some earlier trials showed benefit within 4-6 weeks), but it is concerning that almost all positive trials were supported by one Cuban sponsor. Although the positive trials remain intriguing, morbidity and mortality data have yet to be published. The clinical pathway of lipid-lowering most always begins with exercise and dietary manipulation; if results are suboptimal and the patient remains at risk, those who prefer a nonpharmaceutical approach may opt for agents like niacin (vitamin B3) or red yeast rice (Monascus purpureus), and with some confidence. However, though concerns regarding potential side effects persist, there is little doubt regarding the lipid-lowering effectiveness of pharmaceutical agents. The current study strongly suggests that better options than policosanol exist for controlling high cholesterol, whether alternative or conventional.
What to do with this article: Keep a hard copy in your file cabinet.
Greenfield RH. Policosa--no? Altern Med Alert 2006;9(7):83-84Subscribe Now for Access
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