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Condition Detail



Policosanol

Supplement Forms/Alternate Names:

  • 1-Octacosanol
  • N-Octacosanol
  • Octacosanol Alcohol
  • Octacosanol
  • Wheat Germ Oil
Policosanol is a mixture of waxy substances generally manufactured from sugarcane. It contains about 60% octacosanol, along with many related chemicals. In some cases, the terms octacosanol and policosanol are used interchangeably.
Numerous studies have reported that sugarcane policosanol can substantially improve cholesterol profile, with an efficacy approximately equal to that of the most effective drugs used for this purpose. On this basis, policosanol has been approved as a treatment for high cholesterol in about two dozen countries, most of them in Latin America. 73 However, essentially all positive studies of policosanol were performed and reported by a single Cuban research group—a group with a financial relationship to the product. Independent verification of the product’s effectiveness was delayed for several years by various legal obstacles. During the years 2006 and 2007, however, several independent studies of sugarcane policosanol were at last reported. In none of these trials has policosanol proved more effective than placebo.

Requirements/Sources

The tested Cuban policosanol product is manufactured from sugarcane. Octacosanol and related substances are also found in wheat germ oil, vegetable oils, alfalfa , and various animal products. 1,2
Due to political and patent issues, sugarcane policosanol has not been widely available in the US. Products sold in the US market as "policosanol" are generally derived from beeswax or wheat germ. These products have a significantly different mixture of constituents and could have substantially different effects. 3,77

Therapeutic Dosages

Typical dosages of policosanol in Cuban studies have ranged from 5 mg to 10 mg twice daily.

Therapeutic Uses

The Cuban research group that holds the patent on sugarcane-derived policosanol has published approximately 80 double-blind studies on their product. If these reports are to be believed, a total of several thousand people with elevated cholesterol levels have been enrolled in clinical trials ranging in length from 6 weeks to 12 months, and in virtually every one of these trials policosanol proved both more effective than placebo and equally effective as statin drugs. 29-42,45-53,74,78
However, in science, it is always necessary to have independent confirmation of results before a treatment can be considered proven to work. The first truly independent trials of policosanol as a treatment for high cholesterol began to appear in 2006. Of the many studies published since then, enrolling over 500 people, not one found policosanol more effective than placebo. 79,82,83,85-87,89-91,92 These results have raised serious doubts about the effectiveness of sugarcane policosanol. In addition, questions are now being raised about other scientific claims made by the patent-holding Cuban research group.
Wheat-germ policosanol, sold in the US as substitute for sugarcane policosanol, failed to prove more effective than placebo in the one published clinical trial of this product. 80 There is no published evidence to indicate that beeswax-derived policosanol affects cholesterol profile. A study published in Croatia reportedly found benefit with rice-source policosanol, but it suffered from significant problems in design and reporting. 84
The bottom line : At present, considerable doubt exists regarding whether any form of policosanol offers cholesterol-related benefits.
One study, again conducted by the patent-holding Cuban research group, reported that policosanol is helpful for intermittent claudication . 23
Other potential uses of policosanol have been proposed by non-Cuban researchers. A small double-blind trial found marginal evidence that policosanol might enhance sports performance . 24 Marginal benefits were also seen in a very small, double-blind trial of individuals with Parkinson's disease ; however, this study also reported that policosanol can increase the side effects of the levodopa, the standard drug used for Parkinson’s disease. 25 Finally, in a small double-blind trial, policosanol failed to produce any benefits in amyotrophic lateral sclerosis . 26

Safety Issues

Note : Virtually all statements regarding the safety of policosanol derive from studies reported by the patent-holding Cuban research group. Since the reliability of these researchers is now in question, all of the statements below are similarly open to question.
Given the above caveat, policosanol is said to be safe at the maximum recommended dose. In double-blind trials, only mild short-term side effects have been reported, such as nervousness, headache, diarrhea, and insomnia. A safety study of 27,879 people followed for 2 to 4 years showed that use of policosanol produced adverse effects in only 0.31% of participants, primarily weight loss, excessive urination, and insomnia. 59 In animal studies, no toxic signs were seen even at 620 times the maximum recommended dose. 60-63,72 In addition, policosanol does not adversely affect the liver. 64 Finally, policosanol does not interact with three types of medications used for high blood pressure: calcium-channel antagonists, diuretics, and beta-blockers. 65
On the other hand, policosanol may be a "blood thinner," 66-68,75,81 and it appears to enhance the blood-thinning effects of aspirin, 69 though at least one study failed to confirmed this adverse effect. 88 Still, to be on the safe side, policosanol should not be combined with aspirin or other blood-thinning drugs, such as warfarin (Coumadin), heparin , clopidogrel (Plavix), ticlopidine (Ticlid), or pentoxifylline (Trental). There is also at least a remote chance that it might cause excessive bleeding if combined with natural supplements that thin the blood, such as garlic , ginkgo , and high-dose vitamin E . Similarly, individuals with clotting problems should avoid policosanol, and the supplement should not be used during the period immediately prior to or following surgery or labor and delivery.
One non-Cuban report suggests that policosanol might increase the action of levodopa, a medication used for Parkinson's disease, leading to increased side effects called dyskinesias. 70
The maximum safe dosages for young children, pregnant or nursing women, or individuals with severe liver or kidney disease have not been established.  

Interactions You Should Know About

Do not use policosanol except on medical advice if you are taking:
Keep in mind that policosanol may increase both the effects and side effects of:

References

1 Saint-John M, McNaughton L. Octacosanol ingestion and its effects on metabolic responses to submaximal cycle ergometry, reaction time and chest and grip strength Int Clin Nutr Rev. 1986;6:81-87.

2 Snider SR. Octacosanol in parkinsonism [letter]. Ann Neurol. 1984;16:723.

3 Castano G, Fernandez L, Mas R, et al. Comparison of the efficacy, safety and tolerability of original policosanol versus other mixtures of higher aliphatic primary alcohols in patients with type II hypercholesterolemia. Int J Clin Pharmacol Res. 2002;22:55-66.

4 Crespo N, Illnait J, Mas R, et al. Comparative study of the efficacy and tolerability of policosanol and lovastatin in patients with hypercholesterolemia and noninsulin dependent diabetes mellitus. Int J Clin Pharmacol Res. 1999;19:117-127

5 Crespo N, Alvarez R, Mas R, et al. Effect of policosanol on patients with non-insulin-dependent diabetes mellitus and hypercholesterolemia: a pilot study. Curr Ther Res. 1997;58:44-51.

6 Castano G, Mas R, Fernandez L, et al. Effects of policosanol on postmenopausal women with type II hypercholesterolemia. Gynecol Endocrinol. 2000;14:187-195.

7 Castano G, Mas R, Arruzazabala ML, et al. Effects of policosanol and pravastatin on lipid profile, platelet aggregation and endothelemia in older hypercholesterolemic patients. Int J Clin Pharmacol Res. 1999;19:105-116.

8 Benitez M, Romero C, Mas R, et al. A comparative study of policosanol versus pravastatin in patients with type II hypercholesterolemia. Curr Ther Res. 1997;58:859-867.

9 Ortensi G, Gladstein J, Valli H, et al. A comparative study of policosanol versus simvastatin in elderly patients with hypercholesterolemia. Curr Ther Res. 1997;58:390-401.

10 Alcocer L, Fernandez L, Campos E, et al. A comparative study of policosanol versus acipimox in patients with type II hypercholesterolemia. Int J Tissue React. 1999;21:85-92.

11 Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;19:393-397.

12 Mas R, Castano G, Illnait J, et al. Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors. Clin Pharmacol Ther. 1999;65:439-447.

13 Aneiros E, Mas R, Calderon B, et al. Effect of policosanol in lowering cholesterol levels in patients with type II hypercholesterolemia. Curr Ther Res. 1995;56:176-182.

14 Castano G, Canetti M, Moreira M, et al. Efficacy and tolerability of policosanol in elderly patients with type II hypercholesterolemia: a 12-month study. Curr Ther Res. 1995;56:819-828.

15 Castano G, Tula L, Canetti M, et al. Effects of policosanol in hypertensive patients with type II hypercholesterolemia. Curr Ther Res. 1996;57:691-699.

16 Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;18:393-397.

17 Aneiros E, Calderon B, Mas R, et al. Effect of successive dose increases of policosanol on the lipid profile and tolerability of treatment. Curr Ther Res. 1993;54:304-312.

18 Castano G, Mas R, Nodarse M, et al. One-year study of the efficacy and safety of policosanol (5 mg twice daily) in the treatment of type II hypercholesterolemia. Curr Ther Res. 1995;56:296-304.

19 Batista J, Stusser R, Penichet M, et al. Doppler-ultrasound pilot study of the effects of long-term policosanol therapy on carotid-vertebral atherosclerosis. Curr Ther Res. . 1995;56:906-914.

20 Pons P, Rodriguez M, Mas R, et al. One-year efficacy and safety of policosanol in patients with type II hypercholesterolemia. Curr Ther Res. 1994;55:1084-1092.

21 Pons P, Rodriguez M, Robaina C, et al. Effects of successive dose increases of policosanol on the lipid profile of patients with type II hypercholesterolaemia and tolerability to treatment. Int J Clin Pharm Res. 1994;14:27-33.

22 Pons P, Mas R, Illnait J, et al. Efficacy and safety of policosanol in patients with primary hypercholesterolemia. Curr Ther Res. 1992;52:507-513.

23 Castano G, Mas R, Roca J, et al. A double-blind, placebo-controlled study of the effects of policosanol in patients with intermittent claudication. Angiology. 1999;50:123-130.

24 Saint-John M, McNaughton L. Octacosanol ingestion and its effects on metabolic responses to submaximal cycle ergometry, reaction time and chest and grip strength. Int Clin Nutr Rev. 1986;6:81-87.

25 Snider SR. Octacosanol in parkinsonism. Ann Neurol. 1984;16:723.

26 Norris FH, Denys EH, Fallat RJ. Trial of octacosanol in amyotrophic lateral sclerosis. Neurology. 1986;36:1263-1264.

27 Menendez R, Arruzazabala L, Mas R, et al. Cholesterol-lowering effect of policosanol on rabbits with hypercholesterolaemia induced by a wheat starch-casein diet. Br J Nutr. 1997;77:923-932.

28 Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;18:393-397.

29 Crespo N, Alvarez R, Mas R, et al. Effect of policosanol on patients with non-insulin-dependent diabetes mellitus and hypercholesterolemia: a pilot study. Curr Ther Res. 1997;58:44-51.

30 Castano G, Mas R, Fernandez L, et al. Effects of policosanol on postmenopausal women with type II hypercholesterolemia. Gynecol Endocrinol. 2000;14:187-195.

31 Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;19:393-397.

32 Mas R, Castano G, Illnait J, et al. Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors. Clin Pharmacol Ther. 1999;65:439-447.

33 Aneiros E, Mas R, Calderon B, et al. Effect of policosanol in lowering cholesterol levels in patients with type II hypercholesterolemia. Curr Ther Res. 1995;56:176-182.

34 Castano G, Canetti M, Moreira M, et al. Efficacy and tolerability of policosanol in elderly patients with type II hypercholesterolemia: a 12-month study. Curr Ther Res. 1995;56:819-828.

35 Castano G, Tula L, Canetti M, et al. Effects of policosanol in hypertensive patients with type II hypercholesterolemia. Curr Ther Res. 1996;57:691-699.

36 Aneiros E, Calderon B, Mas R, et al. Effect of successive dose increases of policosanol on the lipid profile and tolerability of treatment. Curr Ther Res. 1993;54:304-312.

37 Castano G, Mas R, Nodarse M, et al. One-year study of the efficacy and safety of policosanol (5 mg twice daily) in the treatment of type II hypercholesterolemia. Curr Ther Res. 1995;56:296-304.

38 Batista J, Stusser R, Penichet M, et al. Doppler-ultrasound pilot study of the effects of long-term policosanol therapy on carotid-vertebral atherosclerosis. Curr Ther Res. 1995;56:906-914.

39 Pons P, Rodriguez M, Mas R, et al. One-year efficacy and safety of policosanol in patients with type II hypercholesterolemia. Curr Ther Res. 1994;55:1084-1092.

40 Pons P, Rodriguez M, Robaina C, et al. Effects of successive dose increases of policosanol on the lipid profile of patients with type II hypercholesterolaemia and tolerability to treatment. Int J Clin Pharm Res. 1994;14:27-33.

41 Pons P, Mas R, Illnait J, et al. Efficacy and safety of policosanol in patients with primary hypercholesterolemia. Curr Ther Res. 1992;52:507-513.

42 Zardoya R, Tula L, Castano G, et al. Effects of policosanol on hypercholesterolemic patients with abnormal serum biochemical indicators of hepatic function. Curr Ther Res. 1996;57:568-577.

43 Castano G, Mas R, Fernandez L, et al. Effects of policosanol on postmenopausal women with type II hypercholesterolemia. Gynecol Endocrinol. 2000;14:187-195.

44 Mas R, Castano G, Illnait J, et al. Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors. Clin Pharmacol Ther. 1999;65:439-447.

45 Castano G, Mas R, Arruzazabala ML, et al. Effects of policosanol and pravastatin on lipid profile, platelet aggregation and endothelemia in older hypercholesterolemic patients. Int J Clin Pharmacol Res. 1999;19:105-116.

46 Crespo N, Illnait J, Mas R, et al. Comparative study of the efficacy and tolerability of policosanol and lovastatin in patients with hypercholesterolemia and noninsulin dependent diabetes mellitus. Int J Clin Pharmacol Res. 1999;19:117-127.

47 Benitez M, Romero C, Mas R, et al. A comparative study of policosanol versus pravastatin in patients with type II hypercholesterolemia. Curr Ther Res. 1997;58:859-867.

48 Ortensi G, Gladstein J, Valli H, et al. A comparative study of policosanol versus simvastatin in elderly patients with hypercholesterolemia. Curr Ther Res. 1997;58:390-401.

49 Alcocer L, Fernandez L, Campos E, et al. A comparative study of policosanol Versus acipimox in patients with type II hypercholesterolemia. Int J Tissue React. 1999;21:85-92.

50 Fernandez JC, Mas R, Castano G, et al. Comparison of the efficacy, safety and tolerability of policosanol versus fluvastatin in elderly hypercholesterolaemic women. Clin Drug Invest. 2001;21:103-113.

51 Castano G, Mas R, Fernandez JC, et al. Efficacy and tolerability of policosanol compared with lovastatin in patients with type II hypercholesterolemia and concomitant coronary risk factors. Curr Ther Res. 2000;61:137-146.

52 Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;18:393-397.

53 Crespo N, Alvarez R, Mas R, et al. Effect of policosanol on patients with non-insulin-dependent diabetes mellitus and hypercholesterolemia: a pilot study. Curr Ther Res. 1997;58:44-51.

54 Castano G, Mas Ferreiro R, Fernandez L, et al. A long-term study of policosanol in the treatment of intermittent claudication. Angiology. 2001;52:115-125.

55 Castano G, Mas R, Roca J, et al. A double-blind, placebo-controlled study of the effects of policosanol in patients with intermittent claudication. Angiology. 1999;50:123-130.

56 Arruzazabala ML, Valdes S, Mas R, et al . Effect of policosanol successive dose increases on platelet aggregation in healthy volunteers. Pharmacol Res. 1996;34:181-185.

57 Carbajal D, Arruzazabala ML, Valdes S, et al. Effect of policosanol on platelet aggregation and serum levels of arachidonic acid metabolites in healthy volunteers. Prostaglandins Leukot Essent Fatty Acids. 1998;58:61-64.

58 Arruzazabala ML, Valdes S, Mas R, et al. Comparative study of policosanol, aspirin and the combination therapy policosanol-aspirin on platelet aggregation in healthy volunteers. Pharmacol Res. 1997;36:293-297.

59 Fernandez L, Mas R, Illnait J, et al. Policosanol: results of a postmarketing surveillance control on 27,879 patients. Curr Ther Res. 1998;59:717-722.

60 Rodriguez-Echenique C, Mesa R, Mas R, et al. Effects of policosanol chronically administered in male monkeys (Macaca arctoides). Fd Chem Toxic. 1994;32:565-575.

61 Mesa AR, Mas R, Noa M, et al. Toxicity of policosanol in beagle dogs: one-year study. Toxicol Lett. 1994;73:81-90.

62 Aleman CL, Mas R, Hernandez C, et al. A 12-month study of policosanol oral toxicity in Sprague Dawley rats. Toxicol Lett. 1994;70:77-87.

63 Rodriguez MD, Garcia H. Teratogenic and reproductive studies of policosanol in the rat and rabbit. Teratog Carcinog Mutagen. 1994;14:107-113.

64 Zardoya R, Tula L, Castano G, et al. Effects of policosanol on hypercholesterolemic abnormal serum biochemical indicators of hepatic function. Curr Ther Res. 1996;57:568-577.

65 Castano G, Tula L, Canetti M, et al. Effects of policosanol in hypertensive patients with type II hypercholesterolemia. Curr Ther Res. 1996;57:691-699.

66 Castano G, Mas R, Arruzazabala ML, et al. Effects of policosanol and pravastatin on lipid profile, platelet aggregation and endothelemia in older hypercholesterolemic patients. Int J Clin Pharmacol Res. 1999;19:105-116.

67 Arruzazabala ML, Mas R, Molina V, et al. Effect of policosanol on platelet aggregation in type II hypercholesterolemic patients. Int J Tissue React. 1998;20:119-124.

68 Arruzazabala ML, Valdes S, Mas R, et al. Effect of policosanol successive dose increases on platelet aggregation in healthy volunteers. Pharmacol Res. 1996;34:181-185.

69 Arruzazabala ML, Valdes S, Mas R, et al . Comparative study of policosanol, aspirin and the combination therapy policosanol-aspirin on platelet aggregation in healthy volunteers. Pharmacol Res. 1997;36:293-297.

70 Snider SR. Octacosanol in parkinsonism [letter]. Ann Neurol. 1984;16:723.

71 Mirkin A., et al. Efficacy and tolerability of policosanol in hypercholesterolemic postmenopausal women. Int J Clin Pharm Res. 2001;21:31-34.

72 Gamez R, eta l. A 6-month study on the toxicity of high doses of policosanol orally administered to Sprague-Dawley rats. J Med Food. 2001;4:57-65.

73 Gouni-Berthold I, Berthold HK. Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent. Am Heart J. 2002;143:356-365.

74 Castano G, Mas R, Fernandez JC, et al. Effects of policosanol on older patients with hypertension and type II hypercholesterolemia. Drugs RD. 2002;3:159-172.

75 Arruzazabala ML, Molina V, Mas R, et al. Antiplatelet effects of policosanol (20 and 40 mg/day) in healthy volunteers and dyslipidaemic patients. Clin Exp Pharmacol Physiol. 2002;29:891-897.

76 Castano G, Mas R, Fernandez L, et al. Effects of policosanol and lovastatin in patients with intermittent claudication: a double-blind comparative pilot study. Angiology. 2003;54:25-38.

77 Illnait J, Terry H, Mas R, et al. Effects of d-002, a product isolated from beeswax, on gastric symptoms of patients with osteoarthritis treated with piroxicam: a pilot study. J Med Food. 2005;8:63-68.

78 Berthold HK, Unverdorben S, Degenhardt R, et al. Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: a randomized controlled trial. JAMA. 2006;295:2262-2269.

79 Berthold HK, Unverdorben S, Degenhardt R, et al. Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: a randomized controlled trial. JAMA. 2006;295:2262-2269.

80 Lin Y, Rudrum M, Van Der Wielen RP, et al. Wheat germ policosanol failed to lower plasma cholesterol in subjects with normal to mildly elevated cholesterol concentrations. Metabolism. 2004;53:1309-1314.

81 Arruzazabala ML, Molina V, Carbajal D, et al. Effects of D-003, a mixture of very long chain fatty acids purified from sugar cane wax, at 5 and 10 mg/day on platelet aggregation in healthy volunteers. Int J Clin Pharmacol Res. 2005;25:29-39.

82 Kassis AN, Jones PJ. Lack of cholesterol-lowering efficacy of Cuban sugar cane policosanols in hypercholesterolemic persons. Am J Clin Nutr. 2006;84:1003-1008.

83 Dulin MF, Hatcher LF, Sasser HC, et al. Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial. Am J Clin Nutr. 2006;84:1543-1548.

84 Reiner Z, Tedeschi-Reiner E, Romic Z. Effects of rice policosanol on serum lipoproteins, homocysteine, fibrinogen, and C-reactive protein in hypercholesterolaemic patients. Clin Drug Investig. 2005;25:701-707.

85 Francini-Pesenti F, Beltramolli D, Dall'acqua S, et al. Effect of sugar cane policosanol on lipid profile in primary hypercholesterolemia. Phytother Res. 2007 Dec 31. [Epub ahead of print]

86 Greyling A, De Witt C, Oosthuizen W, et al. Effects of a policosanol supplement on serum lipid concentrations in hypercholesterolaemic and heterozygous familial hypercholesterolaemic subjects. Br J Nutr. 2006;95:968-975.

87 Cubeddu LX, Cubeddu RJ, Heimowitz T, et al. Comparative lipid-lowering effects of policosanol and atorvastatin: a randomized, parallel, double-blind, placebo-controlled trial. Am Heart J. 2006;152:982,e1-5.

88 Reiner Z, Tedeschi-Reiner E. Rice policosanol does not have any effects on blood coagulation factors in hypercholesterolemic patients. Coll Antropol. 2007;31:1061-1064.

89 Kassis AN, Jones PJ. Changes in cholesterol kinetics following sugar cane policosanol supplementation: a randomized control trial. Lipids Health Dis. 2008 Apr 30.

90 Kassis AN. Evaluation of cholesterol-lowering and antioxidant properties of sugar cane policosanols in hamsters and humans. Appl Physiol Nutr Metab. 2008;33:540-541.

91 Francini-Pesenti F, Brocadello F, Beltramolli D, et al. Sugar cane policosanol failed to lower plasma cholesterol in primitive, diet-resistant hypercholesterolaemia: A double blind, controlled study. Complement Ther Med. 2008;16:61-65.

92 Francini-Pesenti F, Beltramolli D, Dall'acqua S, Brocadello F. Effect of sugar cane policosanol on lipid profile in primary hypercholesterolemia. Phytother Res. 2008;22(3):318-322.

As of 5/3/2011, additional research published on policosanol does not warrant any changes to this article.

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