Policosanol is a mixture of very-long-chain aliphatic alcohols purified from sugar cane wax whose main component is octacosanol. There is no strong evidence at this time that policosanol helps lower cholesterol levels. The research has provided mixed results with some studies showing certain benefits while other studies claiming that policosanol has no benefit in cholesterol management. I have included both positive and negative findings on this policosanol page. I am as confused as most everyone else regarding the role of this nutrient in health and disease, and for the time being I need to see more research with policosanol to determine if it is an effective nutrient to lower cholesterol, and whether higher dosages, such as 40 mg daily, may be more effective. See cholesterol for additional options. Perhaps policosanol has benefits in the human body other than lowering cholesterol, but we don't yet fully understand what these are, if any.

Policosanol, 10 mg, - Source Naturals
Policosanols are a blend of compounds isolated from natural plant waxes.  Policosanol contains several long chain fatty alcohols, including octocossonol, hexacosanol and triacontanol. Animal and in-vitro research has shown that these compounds may support the cardiovascular system and inhibit lipid peroxidation as well as support macrophage activity.

Policosanol Supplement
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Subscribe  to a FREE Supplement Research Update newsletter. Twice a month we email a brief abstract of several studies on various supplements and natural medicine topics - including policosanol and cholesterol - and their practical interpretation by Ray Sahelian, M.D.

Policosanol, a sugar cane extract
Doctors often prescribe drugs called statins for those with cholesterol levels above 200 mg. Many individuals are uncomfortable taking drugs to lower cholesterol and rather prefer to do so by diet and natural supplements. A while back a cholesterol-lowering drug called Baychol, promoted by Bayer corporation, was removed from the market after it caused severe muscle damage and dozens of fatalities. Although statins are effective in lowering cholesterol levels, their long-term side effects are currently not fully known, and muscle damage due to statins is probably more common than many doctors realize.
     There are a few supplements that may help support healthy cholesterol levels including niacin, garlic, guggul, and psyllium.
     Policosanol is a mixture of related compounds derived from the waxy portion of sugar cane. In a randomized, double-blind study done at the National Center for Scientific Research, in Havana, Cuba, investigators evaluated the cholesterol-lowering efficacy of daily intake of 20 mg of policosanol. After 24 weeks, policosanol lowered LDL-cholesterol (the bad cholesterol) by 27 percent and total cholesterol by 15 percent while HDL-cholesterol (the good cholesterol) increased by 17 percent. Policosanol also lowered triglyceride levels by 12 percent. No significant changes occurred in any lipid profile parameters in the placebo group. No unexpected adverse effects were observed. However, a 2006 German study did not find policosanol to reduce cholesterol levels.
        Dr. Sahelian says: The research thus far with policosanol is not conclusive. Some studies show policosanol is helpful in reducing cholesterol while others do not show it to be effective at all.
       Eating small frequent meals, along with cold water fish, lots of vegetables, whole grains, beans, and peas, is helpful in lowering cholesterol levels. Those who are not able to reduce their cholesterol by diet and exercise alone may try policosanol at 20 mg per day along with other nutrients mentioned at the cholesterol  information page (above link), such as fish oils and others. Some people may respond to 40 mg of policosanol a day.
       Statin drugs should be reserved for those who fail to respond to diet and supplements. Nutrients and herbs may not be as powerful as statin drugs but still worth a try before moving on to drugs. Interactions between statin drugs and policosanol, if any, are not well understood.
 

Benefit of Policosanol summary
There is no good evidence yet that policosanol supplements lower cholesterol levels. The research has been mixed with some studies claiming a lowering of cholesterol while others have not shown much benefit from policosanol supplements. Until additional trials are done, we can't say with confidence that this nutrient will lower cholesterol.

Policosanol Research Update
German investigators report that policosanol may not be effective to lower LDL cholesterol. Policosanol is an extract of the waxy coating of sugar cane and other plants, and multiple trials have demonstrated that it safely lowers lipid levels. However, Dr. Heiner K. Berthold says that almost all of these studies came from one group in Cuba, whose research was funded by Dalmer Laboratories, which markets policosanol. In an attempt to confirm their findings, Berthold, from the Drug Commission of the German Medical Association in Berlin, and his team performed a "rigorously controlled" multicenter study comparing Cuban sugar cane-derived policosanol with an inactive "placebo" supplement. Their study involved 143 adults with LDL cholesterol levels of at least 150 milligrams per deciliter. Participants were randomly assigned to policosanol at doses of 10, 20, 40 or 80 milligrams daily or placebo. After 12 weeks, the researchers saw no statistically or clinically significant effect on LDL cholesterol at any dose. Similarly, the investigators report, there were no significant differences among the groups in HDL ("good") cholesterol levels, total cholesterol, very low density-cholesterol, triglycerides, or lipoprotein(a). The study was sponsored by Madaus AG, an international company specializing in plant-derived drugs, which does not manufacture or distribute any cholesterol-lowering drugs. Journal of the American Medical Association, May 17, 2006.

Lack of cholesterol-lowering efficacy of Cuban sugar cane policosanol in hypercholesterolemic persons
American Journal of Clinical Nutrition, Vol. 84, No. 5, 1003-1008, November 2006. Amira N Kassis and Peter JH Jones.
From the School of Dietetics and Human Nutrition, McGill University, Ste-Anne-de-Bellevue, Montréal, Quebec, Canada
More than 50 studies have reported substantial reductions in plasma lipid concentrations in response to 2 – 40 mg Cuban sugar cane policosanol mixtures per day. However, several animal and human trials conducted outside of Cuba that used non-Cuban mixtures have failed to reproduce the efficacy of policosanol observed in earlier studies. The objective was to evaluate lipid-modulating actions of the authentic Cuban sugar cane policosanol on plasma lipids in healthy hypercholesterolemic volunteers. Twenty-one volunteers consumed, under supervision, 10 mg policosanol per day or a placebo incorporated in margarine as an afternoon snack, for a period of 28 d with the use of a randomized, double-blind crossover study design. Subjects maintained their habitual diet and physical activity and were weighed daily throughout the study period. Results: Body weights did not vary significantly throughout the trial and did not affect plasma lipid values. No significant difference was observed between treatment and control groups in plasma total, LDL-, HDL-cholesterol, and triacylglycerol concentrations. Conclusion: Present results show no beneficial effects of Cuban sugar cane policosanol on lipid indicators in hypercholesterolemic persons and question the clinical usefulness of policosanol mixtures as cholesterol-lowering neutraceutical agents.
   My comments: Is 10 mg policosanol too small a dose?

The results of a new study provide more evidence that rice policosanol -- a mixture of alcohols extracted from sugar-cane wax -- has favorable effects on serum lipids. In an 8-week study of 70 patients with very high cholesterol levels, 10 milligrams of rice policosanol daily significantly reduced total cholesterol concentrations in plasma and increased apolipoprotein A1 -- a protein portion of "good" HDL cholesterol that carries cholesterol in the blood. Dr. Zeljko Reiner from University Hospital Centre Zagreb in Croatia and two associates describe their study in the journal Clinical Drug Investigation. The combination of high total cholesterol and "bad" LDL cholesterol and low "good" HDL cholesterol is a major risk factor for heart disease, they note in the paper. Large studies have clearly shown that lowering elevated total and LDL cholesterol through diet, exercise, and cholesterol-lowering drug therapy is beneficial. However, concerns regarding side effects of chemically derived cholesterol-lowering drugs have fueled interest in naturally derived agents, such as rice policosanol. This compound has been shown to lower total and LDL cholesterol in animal models, healthy volunteers, and in those with very high cholesterol levels.

The current findings from Reiner and colleagues support rice policosanol's favorable effects on serum lipids. Compared with placebo, policosanol for 8 weeks significantly lowered plasma total cholesterol from 7.37 to 6.99 mmol/L and increased Apo A1 from 1.49 to 1.58 mmol/L, Reiner and colleagues report. In this brief study, however, the researchers could not prove a significant reduction in triglycerides or LDL cholesterol or increase in HDL cholesterol with policosanol, as has been shown in other studies. It may be that the dose of policosanol used (10 milligrams daily) was too low and the duration of the study was too short, the authors offer. There were no side effects from policosanol therapy. Reiner and colleagues conclude that further study of rice policosanol as a potentially natural cholesterol-lowering aid is warranted. SOURCE: Clinical Drug Investigation, November 2005.

Long-term effects of policosanol on obese patients with Type II Hypercholesterolemia.
Asia Pac J Clin Nutr. 2004;13(Suppl):S102.
Both hypercholesterolemia (HC) and obesity are coronary risk factors. Clinical studies have shown the benefits of lowering elevated plasma levels of low-density lipoprotein-cholesterol (LDL-C) on clinical end-points. Policosanol is a cholesterol-lowering substance purified from sugar cane wax with a therapeutic range from 5 to 20 mg/day. This randomised, double-blinded, placebo-controlled study was undertaken to investigate the long-term efficacy and safety of policosanol in obese patients (BMI>or =30) with Type II hypercholesterolemia. After 5 weeks on step one cholesterol-lowering diet, 129 patients were randomised to policosanol 5 mg or placebo tablets taken once daily with the evening meal for 3 years. After one year on treatment, policosanol significantly lowered serum LDL-C, the primary efficacy variable (24 %) and total cholesterol (TC) (15 %), whereas increased high-density lipoprotein-cholesterol (HDL-C). Changes of lipid variables in placebo were not significant. Treatment effects were persistent, even slightly enhanced, during the trial. At study completion, policosanol had lowered LDL-C (31 %) and TC (20 %), while markedly raised HDL-C (24 %). Thirty patients (18 placebo, 12 policosanol) discontinued the study: 15 (11 placebo, 4 policosanol) due to AE and 12 (9 placebo, 3 policosanol) due to serious adverse events (SAE), most vascular. Policosanol was safe and well tolerated, not impairing significantly any safety indicator. Average body weight was slightly reduced over the study, indicating a general acceptable compliance with dietary recommendations, but policosanol did not show any drug effect on body weight. Overall, 28 placebo and 26 policosanol patients reported some mild or moderate AE during the study. It is concluded that policosanol was effective for lowering cholesterol in obese patients with type II hypercholesterolemia, being also safe and well tolerated.

Effects of concurrent therapy with policosanol and omega-3 fatty acids on lipid profile and platelet aggregation in rabbits.
Drugs R D. 2005;6(1):11-9.
Center of Natural Products, National Center of Scientific Research, Havana City, Cuba.
Policosanol is a mixture of high-molecular-weight aliphatic primary alcohols isolated from sugarcane wax with cholesterol-lowering and antiplatelet effects. Omega-3 fatty acids from fish oil can protect against coronary disease. An antiarrhythmic mechanism is emerging as the most convincing explanation for omega-3 FA cardiovascular protection, but triglyceride (TG)-lowering effects and inhibition of platelet function could play a role. In view of the effects of policosanol and omega-3 FA on lipid profile and platelet function, potential benefits of combined therapy were expected. OBJECTIVE: To investigate whether combined therapy with policosanol and omega-3 FA would offer some benefit, compared with policosanol or omega-3 FA alone, on serum lipid profile and platelet aggregation in rabbits. CONCLUSIONS: Concurrent therapy with policosanol 5 m/kg and omega-3 FA 250 mg/kg lowered LDL-C, TC and TG and increased HDL-C. All treatments inhibited platelet aggregation, but better effects were observed with policosanol + omega-3 FA compared with either treatment alone. Combined therapy was well tolerated. These results suggest that treatment with policosanol + omega-3 FA could be useful for regulating lipid profile and inhibiting platelet aggregation, but conclusive demonstration of such effects requires further experimental and clinical studies.

Wheat germ policosanol failed to lower plasma cholesterol in subjects with normal to mildly elevated cholesterol concentrations.
Metabolism. 2004 Oct;53(10):1309-14.
Sugar cane policosanol, a mixture of long-chain primary alcohols (approximately 67% as octacosanol), has been reported to lower plasma low-density lipoprotein (LDL)-cholesterol. We investigated the effect of wheat germ policosanol (WGP) on plasma lipid profiles in 58 adults (30 men and 28 women, aged 49 +/- 11 years) with normal to mildly elevated plasma cholesterol concentrations in a double-blind, randomized, parallel placebo-controlled study. Subjects consumed chocolate pellets with or without 20 mg/d wheat germ policosanol for 4 weeks. Plasma lipid concentrations, routine blood chemistry and hematology were determined at the start and the end of the study. The initial plasma total, LDL-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triacylglycerol concentrations in the wheat germ policosanol and the control groups were identical. Over the 4 weeks, neither the wheat germ policosanol nor the control treatment significantly changed plasma total cholesterol, LDL- and HDL-cholesterol, or triacylglycerol concentrations when compared to baseline values. In addition, there was no significant difference in plasma lipid profiles between the wheat germ policosanol and the control groups at the end of the study. Wheat germ policosanol did not result in any adverse effects as indicated by plasma activities of L-gamma-glutamyltransferase (gamma-GT), ALT, AST, bilirubin concentrations, and blood cell profiles. Chemical analysis showed that wheat germ policosanol consists of 8% hexacosanol, 67% octacosanol, 12% triacosanol, and 13% other long-chain alcohols, which is similar to the composition of sugar cane policosanol. In conclusion, wheat germ policosanol at 20 mg/d had no beneficial effects on blood lipid profiles. It therefore seems unlikely that the long chain (C24-34) alcohols have any cholesterol-lowering activity.

Long- term effects of policosanol on older patients with Type 2 diabetes.
Asia Pac J Clin Nutr. 2004;13(Suppl):S101.
Diabetes and hypercholesterolemia are major coronary risk factors, coronary risk of diabetics being increased as compared with non-diabetics. The main goal of dyslipidemia control in diabetics is to lower elevated low-density lipoprotein-cholesterol (LDL-C) levels. Policosanol is a cholesterol-lowering substance purified from sugar cane wax, which significantly reduces LDL-C levels and inhibits platelet aggregation. Previous short-term studies have shown the efficacy and tolerability of policosanol at 10 mg/day on patients with Type 2 diabetes, but no previous study on the effects of long-term treatment or lower doses has been reported. This study was undertaken to investigate the long-term efficacy, safety and tolerability of policosanol on patients with Type 2 diabetes. After 5 weeks on a step one cholesterol lowering diet, 239 patients with Type 2 diabetes were randomized to policosanol 5 mg/day or placebo for 2 years. Analysis was by Intention-to-treat. Baseline characteristics were well matched in both groups. After one year, policosanol reduced significantly low-density lipoprotein-cholesterol (LDL-C) (21 %), total cholesterol (TC) (17 %) and triglycerides (TG) (16 %), whereas increased high-density lipoprotein-cholesterol (HDL-C) levels (10 %). No significant changes on lipid profile variables of placebo group occurred during the study. Of 239 randomized patients, 63 (26 %) discontinued the study, 43/120 placebo (35 %) and 20/119 policosanol patients (16 %). Of them, 35 patients (28 placebo, 7 policosanol) withdrew from the study due to some adverse effect. The frequency of serious adverse events, most vascular, in policosanol patients was lower than in respective placebo. Five patients, all placebo, died during the study, four of them due to myocardial infarction. No drug-related impairment of safety indicators, particularly on glycemic control, was observed. Nevertheless, a reduction of systolic and diastolic blood pressure was observed in policosanol patients compared with placebo. The overall frequency of policosanol patients reporting mild and/or moderate was similar than in placebo. It is concluded that policosanol was long-term effective, safe and well tolerated on patients with dyslipidemia due to Type 2 diabetes.

Effects of policosanol and ticlopidine in patients with intermittent claudication: a double-blinded pilot comparative study.
Angiology. 2004 Jul-Aug;55(4):361-71.
Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The present study was undertaken to compare the effects of policosanol and ticlopidine in patients with moderately severe intermittent claudication (IC). The study had a 4-week baseline step, followed by a 20-week double-blinded, randomized treatment period. Twenty-eight eligible patients were randomized to policosanol 10 mg or ticlopidine 250 mg tablets twice daily (bid). Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10 degrees, temperature 25 degrees C) were assessed before and after 20 weeks of treatment. Both groups were similar at baseline. Compared with baseline, policosanol significantly increased (p < 0.01) mean values of initial (ICD) and absolute (ACD) claudication distances from 162.1 to 273.2 m and from 255.8 to 401.0 m, respectively. Ticlopidine also raised significantly ICD (166.2 to 266.3 m) and ACD (252.9 to 386.4 m). Comparisons between groups did not show significant differences. Policosanol, but not ticlopidine, significantly, but modestly, increased the ankle/arm pressure ratio. After 10 weeks, policosanol significantly lowered low-density lipoprotein-cholesterol (LDL-C), total cholesterol (TC) (p < 0.01), and TC/HDL-C and raised (p < 0.05) high-density lipoprotein-cholesterol (HDL-C). At study completion, policosanol lowered LDL-C (30.2%), TC (16.9%), and TC/HDL-C (33.9%), increased HDL-C (+31.7%), and left triglycerides unchanged. Ticlopidine did not affect the lipid profile variable. Policosanol induced modest, but significant, reductions of fibrinogen levels compared with baseline and ticlopidine. Treatments were well tolerated and did not impair safety indicators. Three ticlopidine patients (21.4%) withdrew from the trial, only 1 owing to a serious adverse experience (AE) (unstable angina). Three other ticlopidine patients experienced mild AE (headache, diarrhea, and acidity). It is concluded that policosanol (10 mg bid) can be as effective as ticlopidine (250 mg bid) for improving walking distances of claudicant patients, and it could be advantageous for the global risk of these individuals owing to its cholesterol-lowering effects. This study is, however, just a pilot comparison, so that further studies in larger sample sizes are needed for definitive conclusions of the comparative effects of both drugs on patients with IC.

Meta-analysis of natural therapies for hyperlipidemia: plant sterols and stanols versus policosanol.
Pharmacotherapy. 2005 Feb;25(2):171-83.
Chen JT, Wesley R, Shamburek RD, Pucino F, Csako G.
School of Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette, Indiana
To compare the efficacy and safety of plant sterols and stanols as well as policosanol in the treatment of coronary heart disease, as measured by a reduction in low-density lipoprotein cholesterol (LDL) levels. DESIGN: Systematic review and meta-analysis of randomized controlled trials. PATIENTS: A total of 4596 patients from 52 eligible studies. MEASUREMENTS AND MAIN RESULTS: We searched MEDLINE, EMBASE, the Web of Science, and the Cochrane Library from January 1967-June 2003 to identify pertinent studies. Reduction of LDL levels was the primary end point; effects on other lipid parameters and withdrawal of study patients due to adverse effects were the secondary end points. Weighted estimates of percent change in LDL were -11.0% for plant sterol and stanol esters 3.4 g/day (range 2-9 g/day [893 patients]) versus -2.3% for placebo (769 patients) in 23 eligible studies, compared with -23.7% for policosanol 12 mg/day (range 5-40 mg/day [1528 patients]) versus -0.11% for placebo (1406 patients) in 29 eligible studies. Cumulative p values were significantly different from placebo for both (p<0.0001). The net LDL reduction in the treatment groups minus that in the placebo groups was greater with policosanol than plant sterols and stanols (-24% versus -10%). Policosanol also affected total cholesterol, high-density lipoprotein cholesterol (HDL), and triglyceride levels more favorably than plant sterols and stanols. Policosanol caused a clinically significant decrease in the LDL:HDL ratio. CONCLUSION: Plant sterols and stanols and policosanol are well tolerated and safe; however, policosanol is more effective than plant sterols and stanols for LDL level reduction and more favorably alters the lipid profile, approaching antilipemic drug efficacy.

Concomitant use of policosanol and beta-blockers in older patients.
Int J Clin Pharmacol Res. 2004;24(2-3):65-77.
Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. It is safe and well tolerated, even in populations with high consumption of concomitant drugs. These data suggest that adverse events (AE) due to drug-to-drug interactions (DDI) with policosanol are not relevant. Experimental data indicate that potential DDI between policosanol and drugs metabolized through the cytochrome P450 hepatic system are not expected, but pharmacodynamic DDI 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 DDI between policosanol and beta-blockers can be expected. This study investigated whether policosanol reinforces the antihypertensive effects of beta-blockers and/or whether this combination impairs some safety indicators or induces specific AE in older patients. After 5 weeks on a diet-only baseline period, 205 older hypercholesterolemic patients taking beta-blockers were randomized to policosanol 5 mg/day or placebo for 3 years. After 1 year on therapy, policosanol significantly reduced (p < 0.00001 versus placebo) low-density lipoprotein-cholesterol (LDL-C) (20.9%), total cholesterol (TC) (19.3%) and triglycerides (TG) (25.7%), whereas it increased (p < 0.01 and p < 0.001 versus placebo) high-density lipoprotein-cholesterol (HDL-C) levels (4.1%). Treatment effects did not to wear off during the 3-year follow-up. At study completion, policosanol lowered (p < 0.00001 versus placebo) LDL-C (34.3%), TC (23.2%) and TG (21.2%) and raised (p < 0.00001 versus placebo) HDL-C (12.3%). Thirty-one patients (15.1%) discontinued the study, 22 in the placebo group (20.6%) and nine in the policosanol group (9.2%). Of these, 20 patients (16 in the placebo group and four in the policosanol group) withdrew from the study due to AE. The frequency of serious adverse events (SAE), mostly vascular, in policosanol patients (3/98, 3.1%) was lower than in the placebo group (15/107, 14.0%). No impairment of safety indicators was observed. Nevertheless, reductions in systolic and diastolic blood pressure were observed in policosanol patients compared with those in the placebo group. The frequency of policosanol patients reporting mild or moderate AE (18/98, 18.4%) was also lower than in the placebo group (30/107, 28.0%). In conclusion, policosanol was well tolerated in elderly patients taking beta-block- ers and did not increase AE. Additional reduction of blood pressure and a lower frequency of SAE were observed in policosanol patients compared with those taking placebo. The cholesterol-lowering efficacy of policosanol was that expected. These results provide support that policosanol therapy added to hypercholesterolemic elderly individuals taking beta-blockers could provide additional benefits in lowering blood pressure; SAE were not more frequent in the policosanol group than in the placebo group and there was no increase in AE.

Role of policosanols in the prevention and treatment of cardiovascular disease.
Nutr Rev. 2003 Nov;61(11):376-83.
Policosanols are a mixture of aliphatic alcohols derived from purified sugar cane. When administered at 5 to 20 mg/day, policosanols have been shown to decrease the risk of atheroma formation by reducing platelet aggregation, endothelial damage, and foam cell formation in animals. Additionally, policosanols have been shown to lower total and low-density lipoprotein (LDL) cholesterol levels by 13 to 23% and 19 to 31%, respectively, while increasing high-density lipoprotein (HDL) cholesterol from 8 to 29%. Policosanols are thought to improve lipid profiles by reducing hepatic cholesterol biosynthesis while enhancing LDL clearance. When compared with statins, policosanols exhibit comparable cholesterol-lowering effects at much smaller doses. The mixture is well tolerated when administered to animals; however, a more precise safety profile is needed for humans. In summary, policosanols are a promising resource in the prevention and therapy of cardiovascular disease, but these results need to be confirmed in independent laboratories.

Stability studies of tablets containing 5 mg of policosanol.
Boll Chim Farm. 2003 Sep;142(7):277-84.
The stability studies of tablets containing 5 mg of policosanol, a new cholesterol lowering drug, were conducted to predict an expiration date and to search the appearance of putative degradation products. All quality parameters such as color, moisture content, hardness, disintegration, policosanol content and microbiological limits of the tablets were assessed. The effect of extreme treatments such as acid and basic hydrolysis, oxidative and photolytic degradation as well as thermal degradation, on the policosanol content was studied. In addition, studies under extreme conditions of storage [(40 +/- 2) degree C and (75 +/- 5)% R.H.] as well as 37, 45, 55 and 60 degrees C combined with 50, 75 and 92% R.H.) and under ambient conditions of storage for climatic zones II and IV were performed. These studies demonstrate that these tablets are a stable pharmaceutical formulation, without significant changes in their quality criteria at the stressed conditions used, so that policosanol content remains unchanged during the entire studies. The chromatographic profile of the samples after 9 months of thermal degradation shows chromatographic peaks that corresponds to the palmitate and stearate esters of octacosanoyl, triacontanoyl and hexacosanoyl, being the only degradation products observed on these studies.

Effects of policosanol and lovastatin on lipid profile and lipid peroxidation in patients with dyslipidemia associated with type 2 diabetes mellitus.
Castano G,. Medical Surgical Research Center, Havana City, Cuba.
Int J Clin Pharmacol Res. 2002;22(3-4):89-99.
In this pilot, randomized, double-blind study, we compared the effects of policosanol and lovastatin on lipid profile and lipid peroxidation in patients with dyslipidemia and type 2 diabetes mellitus. After 4 weeks on a cholesterol-lowering diet, 36 patients were randomized to policosanol (10 mg/day) or lovastatin (20 mg/day) tablets o.i.d. for 8 weeks. Policosanol significantly (p < 0.001) lowered serum low-density lipoprotein-cholesterol (LDL-C) (29.9%), total cholesterol (21.1%), triglycerides (13.6%) and the LDL-C/high-density lipoprotein-cholesterol (HDL-C) (36.7%) and total cholesterol/HDL-C (28.9%) ratios and significantly (p < 0.01) increased HDL-C (12.5%). Lovastatin significantly (p < 0.001) lowered LDL-C (25%), total cholesterol (18%), triglycerides (10.9%) and the LDL-C/HDL-C (30.4%) and total cholesterol/HDL-C ratios (23.9%) and significantly (p < 0.01) raised HDL-C (8.3%). Policosanol was more effective (p < 0.05) than lovastatin in reducing both ratios and in increasing (p < 0.05) HDL-C. Policosanol, but not lovastatin, significantly raised the lag time (20.9%) of Cu+2-induced LDL peroxidation and total plasma antioxidant activity (24.2%) (p < 0.05). Both policosanol and lovastatin significantly decreased the propagation rate (41.9% and 41.6% respectively, p < 0.001), maximal diene production (8.3% and 5.7%) and plasma levels of thiobarbituric acid reactive substances (9.7% and 11.5%, p < 0.001). Both treatments were well tolerated. Only one patient in the lovastatin group withdrew from the trial due to adverse events. In conclusion, policosanol and lovastatin administered short term to patients with dyslipidemia secondary to type 2 diabetes were effective in lowering cholesterol and in inhibiting the extent of lipid peroxidation. Policosanol (10 mg/day) was slightly more effective than lovastatin (20 mg/day) in reducing the LDL-C/HDL-C and total cholesterol/HDL-C ratios, in increasing HDL-C levels and in preventing LDL oxidation. Nevertheless, since this was a pilot study, further clinical studies performed in larger sample sizes of diabetic patients are needed for definitive conclusions.

Cholesterol-lowering action of policosanol compares well to that of pravastatin and lovastatin. Cardiovasc J S Afr. 2003 May-Jun;14(3):161.

A 6-Month Study on the Toxicity of High Doses of Policosanol Orally Administered to Sprague-Dawley Rats.
J Med Food. 2001 Summer;4(2):57-65.
Policosanol is a cholesterol-lowering drug purified from sugar cane. Previous toxicological studies have not demonstrated any policosanol-related toxicity, even with long-term oral administration at 500 mg/kg, a dose 1,724 times larger than the maximal therapeutic dose (20 mg/day) recommended to date. The present study was undertaken to investigate the oral toxicity of policosanol administered for 6 months in doses up to 5,000 mg/kg to Sprague-Dawley rats. Animals were randomly distributed in five groups (15 animals per dose per sex): a control and four groups given oral policosanol (50, 500, 2,500, or 5,000 mg/kg). Eight treated rats (6 males, 2 females) died during the study, five of them (4 males, 1 female) from among those receiving the highest dose (5,000 mg/kg). According to necropsy, all deaths were related to gavage manipulation of higher doses. Although the differences were not significant, body weight gain and food consumption in the groups receiving 2,500 or 5,000 mg/kg tended to be lower than in the control group. Nevertheless, no drug-related toxicity symptoms were detected. Analysis of blood biochemistry, hematology, organ weight ratios, and histopathological findings did not show significant differences compared with controls, nor any tendency with the dose. Therefore, the present study did not show any new evidence of oral toxicity of policosanol, and the findings observed were a consequence of long-term administration by gastric gavage of the highly concentrated suspensions needed to reach the higher doses. It is concluded that policosanol chronically administered by the oral route is safe and that no drug-related toxicity was demonstrated.

Policosanol prevents bone loss in ovariectomized rats.
Drugs Exp Clin Res. 2004;30(3):117-23.
Osteoporosis is characterized by reduced bone mass, abnormal bone architecture and increased fracture risk. Ovariectomy impairs bone mass and metabolism in rats and ovariectomized rats are considered as a suitable model of postmenopausal osteoporosis. Mevalonate is required for producing lipoids that are important in osteoclast activity and thus drugs affecting mevalonate production can prevent bone loss in rodents. Policosanol is a cholesterol -lowering drug isolated from sugar cane wax that inhibits cholesterol biosynthesis through an indirect regulation of hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase activity. The purpose of this study was to determine whether policosanol could prevent bone loss in the bones of ovariectomized rats by comparing its effects with those induced by estradiol. Sprague Dawley female rats were randomly distributed in four groups: a sham-operated group treated with Tween/H2O vehicle and three groups of ovariectomized rats treated with 17beta-estradiol (30 microg/kg/day) or policosanol (50 and 200 mg/kg/day), respectively, for 3 months. At treatment completion the rats were sacrificed, their bones removed and variables of bone resorption and formation were investigated by histomorphometry. Ovariectomy increased trabecular separation but diminished the number and thickness of trabecules. Estradiol and policosanol prevented these effects compared with ovariectomized controls. Both treatments also prevented an increase in the number of osteoclasts and their surface area induced by ovariectomy. Estradiol, but not policosanol, significantly prevented an increase of osteoblast surface area compared with ovariectomized controls. In conclusion, policosanol prevented bone loss and decreased bone resorption in ovariectomized rats, suggesting that it should be potentially useful in preventing bone loss in postmenopausal women.

Effect of policosanol on isoprenaline-induced myocardial necrosis in rats.
J Pharm Pharmacol. 1994 Apr;46(4):282-5.
Policosanol is a mixture of higher aliphatic primary alcohols isolated from sugar cane (Saccharum officinarum L.) and octacosanol represents its main component. This study was conducted to examine the effects of policosanol on myocardial necrosis induced by subcutaneous injection of isoprenaline in rats. A significant reduction (P < 0.01) of infarct size, polymorphonuclear cells and mast cells was observed in animals treated with policosanol at 5 or 25 mg kg-1, while animals receiving only acetysalicylic acid pretreatment showed a significant decrease in the infarct area (P < 0.05). No significant differences in polymorphonuclear and mast cells were obtained when compared with positive control data. It is concluded that policosanol delays the evolution of infarction, showing a protective effect on the myocardial necrosis induced by isoprenaline in this experimental model.

Policosanol Emails
Q. I wonder if sytrinol can be combined with other supplements such as policosanol? Are there any contraindications with supplements or medications that the consumer should be aware of?
     A. it is very difficult to predict what will happen when sytrinol and policosanol are combined. There is hardly any research on the individual supplements, let alone the combination. Add to this factor the individual variation in response, additional medicines a person may be taking, the quality of the supplements, timing of intake, diet of the person, etc, and this all makes it so difficult to predict. A good option is to try one supplement, such as policosanol, for a few weeks to see how it works, and then add a second one for a few weeks to see if there are additional benefits.

Q. Are their benefits or cautions in combining guggulsterones with policosanol? I noticed that you note a study on use of policosanol for elderly people on beta-blockers; would use use guggulsterones in conjunction make a positive or negative difference to this?
     A. First, there still is no evidence that policosanol is effective by itself for lowering cholesterol. Second, we are not familiar with research combining policosanol and guggul.

Q. Thanks for all the information on policosanol. However, I'm confused: when replying to an email regarding the effects of combining policosanol with guggul, you say, "First, there still is no evidence that policosanol is effective by itself for lowering cholesterol. Second, we are not familiar with research combining policosanol and guggul." This comes after you publish a series of studies (most not Cuban) that seem to show that policosanol is in fact extremely effective, with the exception of the German study, which was much smaller that most of the others.
     A. There have been some positive studies from Cuba, but some negative studies from other countries, so we are not sure at this point if policosanol is helpful. We are awaiting the results of further studies before speaking with more confidence.

Q. I have high cholesterol and tried policosanol for two months. Results indicate policosanol was not helpful to lower cholesterol.
   A. Most policosanol studies have not been promising as we note on our website.

Q. In 2002, on the advice of a medical doctor, and after a lack of success with policosanol at the regular, 20mg per day dosage, the dosage was doubled to 40mg per day. No policosanol side effects were observed, and my cholesterol levels were significantly affected over a four-month period, without a significant change to my diet. Total cholesterol went from 8.0 mmol/L to 6.0 mmol/L; LDL went from 6.4 mmol/L to 4.4 mmol/L, and HDL went from 1.2 mmol/L to 1.0 mmol/L. Triglycerides went from 2.35 mmol/L to 1.4 mmol/L I noticed that none of the studies in your list for policosanol cited dosages above 20mg per day.
   A. This is interesting. Perhaps policosanol does work but higher amounts need to be taken. We are not certain if any policosanol side effects would occur on higher dosages when tested in a large group of people.

Q. My Policosanol shipment has arrived from the US. Even my doctor here in the UK had not heard of it! I have been on statins since April 2004. I was prescribed Lipitor initially, but this was later replaced by Simvastatin Tablets with a 40mg strength. My blood pressure is currently 106/62, blood sugar level is 6.3 and cholestoral level within the normal range. Would you be kind enough to advise me what potency level of Policosanol I should now take to replace the statins I have been on?
   A. We can't give such individual advice on how much to take or for how long. We suggest your doctor read the page on cholesterol on our website.