Policosanol

Policosanol: A Comprehensive Encyclopedic Reference

1. Identity and Chemical Characterization

Generic Name and Definition

Policosanol is the generic term for a mixture of long-chain alcohols extracted from plant waxes. More precisely, "policosanol" is the generic name given to a mixture of saturated long-chain (C22–C36) primary aliphatic alcohols, in the form of a solid, of waxy consistency, sparingly soluble in water. The term itself is a portmanteau derived from the Spanish poli (many) and cosanol (a suffix shared by long-chain alcohols such as octacosanol, triacontanol, and hexacosanol).

Botanical and Natural Sources

Policosanol contains a mixture of eight primary aliphatic alcohols (24–34 carbons in length) extracted from sugar cane (Saccharum officinarum) wax. Policosanol was originally derived from sugar cane, but the chemicals can also be isolated from beeswax, cereal grains, grasses, leaves, fruits, nuts, and seeds of many foods. The alcohols of which it is composed occur in the natural state in beeswax (from Apis mellifera), in the waxy matrix of sugar cane (Saccharum officinarum), in rice bran (Oryza sativa), and in various other plants. Many policosanols have been purified from various plant sources, such as sugar cane, rice bran, wheat germ, and barley sprout. They are commercially obtained from sugarcane and cereal germs from the milling industries; the total policosanol content of corn kernels varied from 15.2 to 20.5 mg/kg.

Chemical Composition

Policosanols are the chemical name for a mixture of high molecular weight (20–36 carbon) aliphatic primary alcohols, which are constituents of plant epicuticular waxes. They consist of a mixture of long-chain alcohols such as docosanol (22:0), hexacosanol (26:0), octacosanol (28:0), triacontanol (30:0), and dotriacontanol (32:0).

In the canonical Cuban sugarcane product, the compositional profile is more precisely defined. Octacosanol is the predominant moiety, comprising approximately 63% of the mixture. Other important constituents include triacontanol (13%) and hexacosanol (6%). Minor components include tetracosanol, heptacosanol, nonacosanol, dotriacontanol, and tetratriacontanol.

Eight aliphatic fatty alcohols identified in one study were 1-tetracosanol, 1-hexacosanol, 1-heptacosanol, 1-octacosanol, 1-nonacosanol, 1-triacontanol, 1-dotriacontanol, and 1-tetratriacontanol, each having 24 to 34 carbons. The saturated carbon structure results in policosanol being hydrophobic.

Policosanol extracted from Cuban sugarcane wax is a unique blend of eight long-chain aliphatic alcohols (C24, C26, C27, C28, C29, C30, C32, and C34), and has been well recognized for its wide-ranging functionality, which is substantially diverse from the functionality of other policosanols. The composition of policosanol, both in terms of the types and amounts of long-chain aliphatic alcohols, varies considerably depending on the source material's origin and extraction method; consequently, there is a variation in their functionality.

Pharmaceutical Preparation and Forms

Policosanol is commercially available in tablet and capsule forms and is sold as an over-the-counter dietary supplement in many countries. Policosanol is derived through hydrolysis of wax esters and isolation of the alcohol constituent. The policosanol used in some formulations is preferably extracted by means of carbon dioxide in the supercritical state at extremely low temperature in the liquid phase, a process distinct from conventional solvent-based wet extraction methods. Because of political and patent issues, sugarcane policosanol has not been widely available in the United States. Products sold in the American market as policosanol are generally derived from beeswax or wheat germ. These products have a significantly different mixture of constituents and likely have substantially different effects, but they are less well-researched than sugarcane sources.

2. Historical and Developmental Background

Origins of the Isolated Supplement

Policosanol was a name originally given to a unique extract of Cuban sugarcane (Saccharum officinarum) derived from the plant's waxy fraction. In 1964, the Cuban Institute of Research on Sugar Cane Derivatives wanted to identify high-value bioactive sugarcane derivatives. The first product with such potential was policosanol, sold in 40 countries as a patented agent for lowering cholesterol.

The first policosanol supplements were produced by Dalmer Laboratories in Cuba; studies conducted and published by that group found that policosanol is safe and effective as a lipid-lowering agent. Policosanol has been used in Cuba since 1991 to treat high cholesterol. Lipid-lowering properties were described in 1991 in a Cuban study, and until 2004, medical literature on this topic was almost exclusively produced by Cuban researchers.

Pre-Supplement Historical Context

While the isolated compound "policosanol" is a modern discovery (developed in the 1990s in Cuba), its precursors—long-chain alcohols in plant waxes—have been consumed for centuries through whole foods like sugar cane and rice. The isolated, standardized supplement form is therefore a product of 20th-century pharmaceutical research, not a traditionally prepared botanical remedy in the sense of herbal medicine traditions. Its story is primarily one of a government-sponsored pharmaceutical development program in Cuba, not of folk or ethnobotanical use.

International Diffusion

As of 2010, policosanol was marketed as a lipid-lowering agent in the Caribbean, Central and South America, and Canada. In Korea, only policosanol sourced from Cuban sugarcane wax is approved by the Ministry of Food and Drug Safety (MFDS) as a functional food to improve dyslipidemia and hypertension. Policosanol is widely used in dietary supplements across Latin America and Asia and continues to be researched for its metabolic and vascular benefits.

3. Key Active Constituents and Mechanisms of Action

Principal Active Component: Octacosanol

The most pharmacologically studied constituent of policosanol is octacosanol (1-octacosanol; C28H₅₈O), a 28-carbon primary aliphatic alcohol. Policosanol contains about 60% octacosanol and many related chemicals. In some cases, the terms "octacosanol" and "policosanol" are used interchangeably. The full synergistic activity of the mixture, however, is considered to be more than what octacosanol alone provides.

Cholesterol Biosynthesis Inhibition

The mechanism by which policosanol influences lipid metabolism has been intensively studied but remains incompletely elucidated. Policosanol's impact on cholesterol is mediated through a reduction in the synthesis and degradation of the rate-limiting step of cholesterol biosynthesis, the enzyme 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. However, the precise mode of this inhibition differs from that of statins. There is evidence from in vitro studies that policosanol may inhibit hepatic cholesterol synthesis at a step before mevalonate generation, but direct inhibition of the hydroxy-methylglutaryl–coenzyme A reductase is unlikely.

Policosanol decreased acetate incorporation into cholesterol without affecting the incorporation of mevalonate, indicating that these compounds act at or above HMG-CoA reductase. That is, policosanol interrupts or inhibits the metabolic pathway at a point earlier than or preceding any action by HMG-CoA reductase. Policosanol did not directly inhibit HMG-CoA reductase, and incubation of these compounds with hepatoma cells did not affect reductase enzyme levels.

A significant mechanistic finding involves AMP-activated protein kinase. Although the mechanism involved in the anticholesterolaemic effect has not been fully elucidated, there is clear evidence that policosanol induces AMP kinase phosphorylation and inhibits HMG-CoA reductase. The exact mechanism of action of policosanol for lipid lowering has not been sufficiently elucidated, but has been associated with suppression of cholesterol synthesis as well as stimulation of the degradation of LDL cholesterol in liver cells by activating lipases.

Animal studies suggest that LDL catabolism may be enhanced, possibly through receptor-mediated mechanisms, but the precise mechanism of action is not understood yet.

Antiplatelet and Antithrombotic Mechanisms

Policosanol has additional beneficial properties such as effects on smooth muscle cell proliferation, platelet aggregation, and LDL peroxidation. The antiplatelet mechanism appears to involve modulation of arachidonic acid metabolism. Suppression of platelet aggregation is believed to be associated with the effect of prostaglandin synthesis. That is, policosanol lowers the level of thromboxane A2 in the serum and increases prostacyclin level, thereby reducing the risk of thrombosis.

In a placebo-controlled clinical study, a 2-week, randomized, double-blind, placebo-controlled trial investigated the effects of policosanol on platelet aggregation and thromboxane B2 and prostacyclin production after stimulation with collagen in healthy volunteers, who received placebo or policosanol (10 mg/day) for 15 days. Significant reductions of arachidonic acid and collagen-induced platelet aggregation were observed. Thromboxane, but not prostacyclin, generation induced by collagen was also inhibited by policosanol. A dose-response relationship has also been documented: results showed that antiplatelet effects of policosanol were successfully enhanced throughout successive dosing steps, suggesting a dose-dependent relationship. No significant effect was reached during the first dosing period, but significant reductions of epinephrine and ADP-induced platelet aggregation were observed after the second dosing step; a significant inhibition of platelet aggregation induced by all agonists was observed at the last dosing step.

HDL Enhancement and CETP Inhibition

Policosanol has been reported to improve blood pressure, lipid profile, and HDL functionality via inhibition of cholesteryl ester transfer protein (CETP) both in vitro and in vivo in zebrafish and human models. In addition to the increase in HDL-C quantity, improvement of HDL quality and functionality should also be considered to maximize the efficacy of policosanol. The HDL quality in the blood and the antioxidant and anti-inflammatory properties may be improved by policosanol consumption, because dysfunctional HDL is more atherogenic and exacerbates the pro-inflammatory cascade.

Antioxidant Activity

Policosanol prevents low-density lipoprotein (LDL) from oxidative injury and exhibits a substantial anti-glycation effect. Antioxidant ability in plasma was elevated while oxidation of LDL was reduced upon policosanol consumption in one human trial. Policosanol consumption is known to improve the lipid profile and inhibit LDL oxidation.

4. Scientific Evidence by Area of Use

4.1 Lipid-Lowering and Dyslipidemia

Cuban Clinical Trial Literature (Pre-2004)

The bulk of early clinical evidence originates from a single Cuban research group. 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. A number of reasonably well-designed, short- and long-term trials found that policosanol significantly lowered both LDL and total cholesterol levels in patients with familial hypercholesterolemia, patients with type 2 diabetes mellitus, postmenopausal women, and elderly patients. Some longer-term studies have shown that policosanol significantly raises HDL cholesterol levels.

At doses of 10 to 20 mg per day, significant reductions were observed for total cholesterol (17% to 21%) and LDL cholesterol (21% to 29%) with increases in HDL cholesterol (8% to 15%). One Cuban study in older patients with hypertension and type II hypercholesterolemia found that policosanol significantly lowered serum LDL-C (20.5%), total cholesterol (15.4%), triglycerides (11.9%), LDL-C/HDL-C ratio (22.2%), and TC/HDL-C ratio (20.1%), and increased HDL-C (12.7%).

A Cuban study comparing policosanol with atorvastatin in patients with dyslipidemia and type 2 diabetes reported that after 8 weeks of therapy, policosanol significantly lowered LDL-C by 25.7% and total cholesterol by 18.2%. In turn, atorvastatin 10 mg/day decreased LDL-C by 41.9%.

Independent (Non-Cuban) Clinical Trials: Contradictory Evidence

The Cuban data was substantially challenged beginning in 2004–2006 by independent researchers in Europe and North America. Despite the abundance of articles reporting significant cholesterol-lowering effects, it is extremely important to note that most of the positive studies have been published by one research group in Havana, Cuba, where the original product was developed by Dalmer Labs Inc.

The most influential negative study was published in JAMA in 2006. The German researchers performed a placebo-controlled trial with Cuban sugar-cane-derived policosanol in 143 patients with hypercholesterolemia or combined hyperlipidemia. Patients were randomized to receive 10, 20, 40, or 80 mg/day of policosanol or placebo for 12 weeks. Results showed that LDL levels did not decrease by more than 10% from baseline in any of the five groups, and there was no statistically significant difference between policosanol and placebo in the reduction in LDL or in any of the other lipid parameters measured.

The beneficial effect of policosanol on cholesterol has come into question with the publication of several negative trials. In 2006, two studies were published that revealed no changes in lipid variables in subjects who received policosanol. These studies examined both the Cuban-derived policosanol preparation in doses ranging from 10 mg to 80 mg and a commercially available policosanol supplement (Octa-60) in a 20-mg once-daily dose. In 2004, a Dutch research group tested a standard 20-mg dose of policosanol derived from wheat germ and also found no effect.

A North American randomized controlled trial (double-blind, n=40) assigned adults with mild hypercholesterolemia to receive oral policosanol 20 mg or placebo once daily for 8 weeks. No significant differences in the change in LDL cholesterol were observed between the placebo and policosanol groups. Also, no significant changes in secondary outcome measures, including total cholesterol, HDL cholesterol, triacylglycerol, C-reactive protein, and NMR spectroscopy-determined profiles, were observed. Policosanol was well tolerated, and no significant adverse events were noted. The conclusion was that policosanol does not alter the serum lipid profile over an 8-week period in adults with mild hypercholesterolemia.

A McGill University randomized double-blind crossover study (n=21 hypercholesterolemic subjects, 28 days, 10 mg/day policosanol) found that there was no significant change in LDL cholesterol levels as compared to control. Independent research examining changes in cholesterol kinetics in response to sugar cane policosanol is limited to few studies, none of which was able to replicate findings of the original research.

Meta-Analyses

A meta-analysis in 2005 concluded that human policosanol consumption is safe and well tolerated and is effective at lowering blood cholesterol. However, this analysis drew heavily on the Cuban literature. Another meta-analysis published in 2018 with 22 studies and 1,886 subjects showed policosanol could improve dyslipidemia with raising HDL. A separate meta-analysis of sugar cane policosanol found that a total of 875 participants were given policosanol and 878 received placebo; overall percent change in total cholesterol favored policosanol (−7.24%) with a significant difference (p=0.0003), and a significant difference was likewise seen in LDL-C (p=0.001) also favoring policosanol.

Evidence strength summary for lipid lowering: The evidence base is highly polarized. Numerous Cuban RCTs (before 2004) consistently reported significant lipid-lowering effects comparable to statins. However, all well-designed independent trials conducted outside Cuba—including a 143-patient RCT published in JAMA (2006)—failed to replicate these results. The majority of the existing studies have been conducted in Cuba, and independent verification is needed before its use can be recommended. The current consensus among independent reviewers is that the cholesterol-lowering evidence is, at best, mixed, and that the Cuban results have not been reliably replicated elsewhere.

4.2 Intermittent Claudication and Peripheral Vascular Disease

Policosanol has favorable effects on intermittent claudication, possibly due to its effects on platelet aggregation and endothelial function. Clinical trials indicate that policosanol may have applications in the treatment of intermittent claudication. The evidence in this area comes almost entirely from Cuban clinical research.

A randomized, double-blind, placebo-controlled long-term study enrolled 56 patients with moderately severe intermittent claudication. The study consisted of a 6-week single-blind, placebo-controlled run-in phase, followed by a 2-year double-blind, randomized treatment step, in which patients were randomized to receive placebo or policosanol 10 mg twice daily. Walking distances on a treadmill (constant speed 3.2 km/h, slope 10°, temperature 25°C) were assessed before and after 6, 12, 18, and 24 months of treatment. After 6 months of therapy, policosanol significantly increased the initial claudication distance from 125.9 m to 201.1 m and the absolute claudication distance from 219.5 m to 380.7 m.

A separate double-blind comparative pilot study compared policosanol with lovastatin in intermittent claudication patients. Compared with baseline, policosanol increased significantly the initial claudication distance (ICD) from 160.39 m to 211.31 m (+33.7%) and the absolute claudication distance. A comparison with aspirin (100 mg/day) found that policosanol significantly increased the initial and absolute claudication distances, while aspirin changed neither variable.

Evidence strength for intermittent claudication: Studies are encouraging but originate almost entirely from the Cuban research group. The same concerns about independent replication that apply to the cholesterol literature apply here. No Cochrane review specific to policosanol for intermittent claudication has been identified. The evidence is therefore preliminary and requires confirmation from independent centers.

4.3 Blood Pressure

The blood pressure-lowering effect of Cuban policosanol has been shown in an animal model using spontaneously hypertensive rats and a human trial. There are limited reports and randomized, double-blinded trials on policosanol that could advocate the blood pressure-lowering effect in prehypertensive participants.

A randomized, double-blinded, placebo-controlled Korean study examining Cuban policosanol in healthy prehypertensive women found that after 8 weeks, consumption of policosanol enhanced plasma antioxidant activity; plasma total cholesterol and triglyceride levels were reduced up to 20% and 14%, respectively, and HDL-C level was elevated up to 1.3-fold compared to baseline. TG/HDL-C and CETP activities were reduced up to 36% and 20%, respectively.

A 12-week randomized, placebo-controlled, double-blinded trial in healthy Japanese subjects found that the policosanol group showed significantly higher HDL-C level and HDL-C/TC (%) than the placebo group. In lipoprotein analysis, the policosanol group showed a decrease in oxidation and glycation extent in VLDL and LDL with an improvement of particle shape and morphology after 12 weeks. HDL from the policosanol group showed in vitro stronger antioxidant and in vivo anti-inflammatory abilities. In conclusion, 12 weeks of Cuban policosanol consumption in Japanese subjects showed significant improvement in blood pressure, lipid profiles, hepatic functions, and HbA_1c with enhancement of HDL functionalities.

Evidence strength for blood pressure: Preliminary. Most human trial evidence is from small studies with specific populations (prehypertensive women, Japanese subjects) conducted by groups with access to the Cuban-sourced product. Effect size and independent replication remain to be established.

4.4 LDL Oxidation and Antioxidant Effects

Cuban researchers studied the effect of policosanol (5 and 10 mg/day) on LDL-C oxidation in a double-blind, randomized, placebo-controlled trial conducted in 69 subjects. The study found evidence of reduced LDL susceptibility to oxidation. However, one independent Canadian study found that sugar cane policosanols do not reduce LDL oxidation in hypercholesterolemic individuals. The antioxidant effect is therefore also not consistently replicated outside Cuba.

4.5 Other Investigated Areas

Many policosanols from different sources have been used to treat blood dyslipidemia, hypercholesterolemia, diabetes, hypertension, and dementia by raising the HDL-C and lowering the LDL-C. In addition to cholesterol management, policosanol has been explored for various other uses, including potential benefits for intermittent claudication, sports performance, and even conditions like Parkinson's disease. The established role of policosanol as platelet anti-aggregation, amelioration of neurological function in ischemic stroke patients, and blood pressure maintenance has been reported in preclinical and some clinical contexts, but for these indications the evidence is limited and exploratory.

Policosanol in combination with classical statins displayed a substantial effect to minimize the toxic effect of statins, and its possible use as combination therapy was proposed. Furthermore, a recent study found that a combination of high-intensity exercise and Cuban policosanol intake in obese individuals improved hypertension and dyslipidemia.

5. Body Systems and Health Areas Associated with Policosanol

• Cardiovascular system (lipid metabolism): Primarily studied for LDL-C reduction, total cholesterol reduction, and HDL-C elevation. Evidence is strong within the Cuban literature but not independently replicated.
• Cardiovascular system (platelet function and thrombosis): Inhibits platelet aggregation, lowers thromboxane A2, and may reduce thrombotic risk. Cuban RCTs and some external studies support this effect.
• Vascular system (peripheral arterial disease): Multiple Cuban trials report improved walking distance in intermittent claudication, attributed in part to antiplatelet and lipid effects.
• Cardiovascular system (blood pressure): Preliminary human evidence from Korean and Japanese trials suggests modest antihypertensive effects, particularly in prehypertensive individuals, via CETP inhibition and HDL enhancement.
• Metabolic function (glucose metabolism): Some recent trials have reported lowering of glycated hemoglobin (HbA_1c) and improvements in hepatic enzyme markers, but data are limited.
• Oxidative stress (antioxidant/anti-glycation): In vitro and some human studies report reduced LDL oxidation and improved plasma antioxidant capacity, though not replicated in all independent studies.

6. Dosage Forms and Reported Dosages

Policosanol is commercially available primarily as oral tablets or capsules. The following dosages are as reported in cited clinical sources:

• Policosanol is typically initiated at 5 mg/day and titrated up to 20 mg/day for hypercholesterolemia.
• Adjunctive use of 40 mg/day for 30 days has been used with antiplatelet regimens after percutaneous stent implantation.
• Typical dosages of policosanol in Cuban studies have ranged from 5 to 20 milligrams daily for up to three years. Many supplement manufacturers recommend taking 10 mg daily.
• In some studies, participants used 40 to 80 mg daily for twenty-four weeks.
• In the Berthold et al. JAMA 2006 trial, patients were randomized to 12 weeks of treatment at doses of 10, 20, 40, or 80 mg/d.
• In the long-term claudication study, 56 patients were randomized to receive placebo or policosanol 10 mg twice daily.
• Twelve weeks of Cuban policosanol consumption at 10 and 20 mg was associated with improved blood pressure and lipid/lipoprotein profile.
• In a healthy-volunteer platelet aggregation trial, participants received policosanol 10 mg/day for 15 days.

7. Safety Profile, Adverse Effects, and Drug Interactions

General Tolerability

Animal and human studies have demonstrated few adverse reactions from policosanol. Limited animal and human studies have found policosanol to be safe. Studies conducted in humans and across various animal models have established the safety and non-toxicity of policosanol.

Post-marketing surveillance data from Cuba is notable: in a post-marketing survey with over 27,000 participants, only 0.07% reported polyuria and weight loss, while 0.05% reported polyphagia following the intake of policosanol.

In the large Cuban study of older patients with hypertension and hypercholesterolemia, the frequency of vascular and all-cause serious adverse events was lower in the policosanol recipients (two vascular SAEs, 0.7%; five all-cause SAEs, 1.7%) than in the placebo recipients (six vascular SAEs, 2.0%; 12 all-cause SAEs, 4.1%). Total adverse events were less frequent in the policosanol-treated group (29; 9.8%) compared with the placebo group (52; 17.7%).

In the North American RCT (Kassis et al., 2006), policosanol was well tolerated, and no significant adverse events were noted.

Animal Toxicology

Studies in rats and mice demonstrated no adverse effects on fertility, reproduction, teratogenesis, or development at doses equivalent to 1,500 times the normal human dose of 20 mg/kg/day. Policosanol consumption at a dose 1,500 times higher than the usual human dose showed no evidence of toxicity in animal models, including monkeys, dogs, rats, and mice. At 1,500 times the usual human dose, policosanol was found safe with respect to reproductive health and fertility in mice and rats.

Antiplatelet Interactions and Surgical Risk

Caution should be exercised when combining policosanol with antiplatelet or anticoagulant agents, including garlic, ginkgo, and high doses of vitamin E, as policosanol has been shown to inhibit platelet aggregation in both healthy and diseased patients. Specifically, because of policosanol's potential effects on platelet aggregation, caution is warranted if it is used concurrently with anticoagulants (e.g., warfarin) or antiplatelet agents (e.g., aspirin, clopidogrel, prasugrel). However, a study in 11 healthy men receiving warfarin 25 mg before and after treatment with policosanol 10 mg twice daily for 2 weeks found no effect of policosanol on the pharmacokinetics of (S)- or (R)-warfarin. Policosanol also did not alter the response to warfarin on platelet aggregation.

Beta-Blocker and Antihypertensive Interactions

Experimental data indicate that potential drug–drug interactions between policosanol and drugs metabolized through the cytochrome P450 hepatic system are not expected, but pharmacodynamic interactions cannot be excluded. Several clinical studies have shown that policosanol decreased arterial pressure compared with placebo, and a pharmacological interaction with beta-blockers was experimentally proven. Therefore, clinical interactions between policosanol and beta-blockers can be expected. Animal studies suggest policosanol may increase the hypotensive effects of beta-blockers and nitroprusside.

Pregnancy and Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking.

Contraindications

Contraindications have not been identified in the published literature reviewed, though the absence of identified contraindications should not be interpreted as an established safety profile in all populations, given the generally limited scope of independent research.

Source-Dependent Composition and Efficacy Differences

A critical safety and efficacy consideration is the variability in commercial products. Different mixtures of higher aliphatic alcohols are on the market under the name "policosanol" claiming, without the support of independent data, the therapeutic efficacy and tolerability that former studies had demonstrated for the original policosanol. This name originally referred to a mixture of eight higher aliphatic primary alcohols obtained at the beginning of the 1990s from sugarcane wax, patented by Cuban researchers. Analysis by GC-MS shows qualitative/quantitative differences in policosanol-like preparations from different plant sources and origins. Different brands displayed distinct impacts against hypercholesterolemia-induced adverse effects, signifying the importance of policosanol formulation and the presence of aliphatic alcohols on the functionality of policosanol products.

8. The Cuban Research Controversy: An Evidence Appraisal

The scientific status of policosanol is unique in the dietary supplement landscape due to a stark bifurcation between an internally consistent body of Cuban research and a body of independent international studies that fail to replicate its findings. The anticholesterolaemic activity and some desirable pleiotropic effects (decreased platelet aggregation, LDL oxidation, thromboxane production and foam-cell production) of the original policosanol have been confirmed by more than 50 clinical studies. Yet, these studies were small, and efforts by groups outside of Cuba have failed to replicate these results.

Most of the published scientific literature supporting the beneficial effects of policosanol on lipids has been conducted by a single research group from Cuba, and therefore studies from groups outside Cuba and in non-Hispanic populations are needed. These results have recently been questioned by a few authors who have reported a modest or negligible activity of policosanol, whether from sugar cane or from other plant sources. Possible explanations for the discrepancy that have been raised in the literature include subtle compositional differences in Cuban versus non-Cuban policosanol preparations, differences in the ratios of individual long-chain alcohols, differences in study populations, and the possibility of investigator or publication bias in the Cuban literature. The discrepancy between the findings may be due to subtle composition differences of the components like the differences in the constituents' ratio.

Although there have been many conflicting data and arguments about the cholesterol-lowering efficacy of policosanol, a recent meta-analysis of randomized controlled trials from 22 studies including 1,886 subjects concluded that policosanol could significantly reduce total cholesterol and LDL-C and increase HDL-C. Nonetheless, data on efficacy determined by clinical end points such as rates of cardiac events or cardiac mortality are lacking. The overall evidentiary picture therefore supports significant uncertainty, and independent large-scale trials using well-characterized preparations are needed to resolve the question definitively.

References

• ScienceDirect Topics: Policosanol (Agricultural and Biological Sciences)
• ScienceDirect Topics: Policosanol (Medicine and Dentistry)
• Medscape: Policosanol Monograph (Pepping JD)
• Wikipedia: Policosanol
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• PMC: Cuban Sugarcane Wax Alcohol Supplementation Prevents Brain and Eye Damages of Zebrafish
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• PubMed: Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial (Kassis et al., 2006)
• PubMed: A long-term study of policosanol in the treatment of intermittent claudication (Castaño et al., 2001)
• PubMed: Effects of policosanol and lovastatin in patients with intermittent claudication (Castaño et al., 2003)
• PubMed: Effect of policosanol on platelet aggregation and serum levels of arachidonic acid metabolites in healthy volunteers
• PubMed: Effect of policosanol successive dose increases on platelet aggregation in healthy volunteers
• PubMed: Effects of policosanol on older patients with hypertension and type II hypercholesterolaemia
• PubMed: Comparison of the effects of policosanol and atorvastatin on lipid profile and platelet aggregation in patients with dyslipidaemia and type 2 diabetes mellitus
• PubMed: Concomitant use of policosanol and beta-blockers in older patients
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• PMC: Beneficial Effect of Cuban Policosanol on Blood Pressure and Serum Lipoproteins in a Randomized, Placebo-Controlled, Double-Blinded Trial with Healthy Japanese
• PMC: Effects of policosanol treatment on the susceptibility of LDL isolated from healthy volunteers to oxidative modification in vitro
• PMC: Consumption of policosanol enhances HDL functionality via CETP inhibition and reduces blood pressure and visceral fat
• PMC: Efficacy Assessment of Five Policosanol Brands and Damage to Vital Organs in Hyperlipidemic Zebrafish
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