Side Effects, Safety, Benefits, sugar cane, Research study    October 22, 2011
Further Study about policosanol's effect on cholesterol level
McCarty MF combined policosanol and ezetimibe to reduce LDL cholesterol by about 40%. [12] Policosanol intensifies
the cholesterol-lowering effect and platelet aggregation of omega-3 fatty acids in rabbits. [15]

Compared to statins, policosanol exhibits comparable cholesterol-lowering effects and it is well tolerated in animals.
Researchers demonstrated that policosanol (10 mg/day) was even 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. Nikitin IuP et al concluded that the hypolipidemic effect of policosanol in a daily dose of 10 mg is superior to
that of besafibrate in a daily dose of 400 mg from their study of 113 patients with hypercholesterolemia.

Policosanol may benefit people at risk of cardiovascular conditions. In a rat study, it inhibits platelet aggregation after 4
weeks treatment. [20] In another study, policosanol was administered at 20 mg/day for 7 days significantly inhibited
platelet aggregation, while the low policosanol dosage (5 mg/day) was ineffective. No adverse-effects were reported.
[21] In one study, policosanol combined with aspirin reduced platelet aggregation significantly in study of healthy
subjects. [22] while, in another study, policosanol together with aspirin significantly protected Mongolian gerbils from
cerebral ischemia. [23]

There are more evidence for policosanol benefits on cardiovascular conditions. Such as, policosanol inhibited lipid
peroxidation in experimental models and human beings. [24] In a study, policosanol showed a protective effect on
atherosclerotic lesions in a study of 54 Wistar rats. [25] while, in another study, policosanol increased in the oxidative
capacity in the muscle of exercise-trained rats. [26] Policosanol combined beta-blockers provided additional benefits
on blood pressure lowering in elderly with high cholesterol levels. [27] And, policosanol delayed the onset of infarction
or myocardial necrosis induced by isoprenaline in animal studies. [28]

In most cases, policosanol side effects were not observed. However, one study indicated that policosanol produced
adverse side effects in 0.31% of the population and the adverse side effects included weight loss, excessive urination
and insomina. Policosanol side effect and safety issue from various studies are summarized as follows:

Animal [Non-human] Studies
Policosanol was safe in the animal studies. Basically, policosanol was well-tolerated and accepted with no toxic
symptoms (including signs of cancer)  to animals such as mice, rats, dogs and monkeys. The study periods are from
12 months to 54 months. [A1-5] Toxic nor side effects related to reproduction were not found, after administration from
2 weeks prior to mating and throughout mating and pregnancy to day 21 of lactation. [A6]

Human Studies
HEALTHY HUMAN SUBJECT Researchers applied single doses (5-50 mg) to healthy volunteers. Policosanol
administered at 20 mg/day for 7 days significantly inhibited platelet aggregation. No toxic nor side effects were
observed. .[32] In another study, long-term tolerability of policosanol in 2252 elderly patients at high vascular risk was
found to be acceptable. No serious toxic nor side effects were reported in the study. In another study, policosanol was
well tolerated and safe in a study of 4596 patients. No serious adverse nor side effects were found. [33]

In a two-year study on the efficacy and tolerability (i.e.safety), researchers supplied 5 mg of policosanol twice-a-day to
69 patients suffered from type II hyperlipoproteinaemia. They found reduction in LDL-C and cholesterol, no
drug-related clinical or biochemcial adverse effects but mild, transient adverse experiences. [34] In another study,
Nikitin IuP et al, compared efficacy and tolerance of polycosanol vs besafibrate in 113 patients with
hypercholesterolemia. 59 patients received polycosanol (10 mg/day), 54 patients were given besafibrate (400 mg/day)
for 8 weeks. After 8-week course of treatment, daily 10 mg of policosanol is more effective on cholesterol-lowering.
And,  the adverse effects in the group taking policosanol were mild. [35] In one study, policosanol combined with
ezetimibe reduced LDL cholesterol without adverse effects. [36] Finally, one report says policosanol side-effects may
include skin rash, headache, insomnia and gastrointestinal disturbances. [C1] A long term study reported that
policosanol produced adverse effects in 0.31% of the population and the side effects included weight loss, excessive
urination and insomina. [C2] Policosanol can also affect platelet aggregation, as disscussed above. [C3-C5]

Policosanol is more effective than plant sterols and stanols for LDL level reduction in a study of 4596 patients. Plant
sterols, stanols and policosanol are well tolerated and safe. [37]

Compared with statins, policosanols exhibit comparable cholesterol-lowering effects at much smaller doses. [38]

Policosanol was more effective than lovastatin in reducing cholesterol levels.in a study of patients with dyslipidemia
secondary to type 2 diabetes. [39]

Policosanol was found to be more effective than Octa-60 (higher aliphatic primary alcohols) in a study of 110 patients
with with type II hypercholesterolemia. [40]

Policosanol combined with ezetimibe reduced LDL cholesterol by about 40%. [41]

Policosanol at a dose of 40 mg/day does not offer significant additional cholesterol-lowering efficacy over the 20
mg/day dose in a 6-month study. [42]

Policosanol Sources include sugarcane, beewax, wheat germ and alfalfa. Wheat germ policosanol failed to lower
cholesterol levels in 58 with normal to mildly elevated plasma cholesterol concentrations. [43] Researchers at
Oklahoma State University found that wheat varieties grown under identical conditions differed significantly in
policosanol content and composition. The policosanol content of wheat bran was higher than that of the germ, shorts
and flour. The Trego and Intrada varieties had the highest policosanol components in all varieties studied.
Tetracosanol, hexacosanol and octacosanol were the major policosanol components in all varieties. [44]There are also
conflicting results with sugar cane policosanols on cholesterol lowering effects:
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Animal Study on Policosanol, Sugar Cane
Murphy KJ and colleagues, University of South Australia, conducted a study to evaluate the potential for a mixture of
policosanol extracted from sunflower oil to lower blood cholesterol levels in comparison to sugar cane policosanol in
rabbits. In the study, 23 Semi-lop rabbits were blocked into three groups matched on fasting plasma cholesterol levels
then randomly assigned to one of three parallel treatment arms. Total cholesterol, non-HDL and HDL cholesterol
increased significantly following sugar cane policosanol supplementation relative to the control. Sunflower oil
supplementation had no effect. Dietary supplementation of normocholesterolemic rabbits with policosanol from
sunflower oil does not appear to have any cholesterol lowering effect. A similar lack of efficacy observed with the
commercial sugar cane policosanol product which we evaluated raises doubts about the purported
cholesterol-lowering efficacy of these products, as reflected in the current literature. [2] Dullens SP and colleagues at
Maastricht University, The Netherlands, present that neither the individual policosanol components (C24, C26, C28
sugar cane, or C30) nor the natural policosanol mixture (all 30 mg/100 g diet) lowered serum cholesterol
concentrations in LDL receptor knock-out (LDLr(+/-)) mice. None of the individual policosanols or their respective
long-chain fatty acids or aldehydes affected de novo apoA-I protein production in vitro in HepG2 and CaCo-2 cells.
They concluded that the evaluated individual policosanols, as well as the natural policosanol mixture, have no
potential for reducing coronary heart disease risk through effects on serum lipoprotein concentrations. [P6]

Clinical Studies on Policosanol, Sugar Cane
A study led by Kassis AN and colleagues from McGill University, Canada, found policosanol, sugar cane, did not
reduce LDL oxidation in hypercholesterolemic individuals. The objective of the study was to confirm the effects of
Cuban Sugar cane policosanols on LDL oxidation using a high-precision capture ELISA procedure in
hypercholesterolemic individuals. Twenty-one otherwise healthy hypercholesterolemic men and post-menopausal
women participated in a randomized double blind crossover study where they received
10 mg/day of policosanol or a
placebo incorporated in margarine as an evening snack for a period of 28 days. Subjects maintained their usual
dietary and exercise habits throughout the duration of the study. Blood was collected on the first as well as the last 2
days of the trial. LDL oxidation was measured from plasma using a solid phase two-site enzyme immunoassay. A lack
of effect of Sugar cane policosanols was observed on LDL cholesterol levels, as well as no difference in LDL oxidation
between the Sugar cane policosanols treatment and placebo at the end of the intervention period. Subject body
weights remained stable throughout the study and showed no significant correlation with LDL oxidation levels.
Absolute levels of plasma LDL cholesterol were significantly correlated with plasma concentrations of oxidized LDL.
The findings of the study suggest that Sugar cane policosanols do not significantly affect LDL oxidation. [P1, P4]

Another study led by Francini-Pesenti F,A at al, Azienda Ospedaliera, Italy, was performed in hypercholesterolaemic,
diet-resistant patients on polycosanol, sugar cane. Seventy patients meeting the selection criteria were enrolled. Each
subject was treated with policosanol
10 mg/d in addition to a dietetic regimen for 8 weeks. Thirty-three subjects in the
policosanol and Thirty-one subjects in the control group completed the study. During the study body mass index, total
cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides plasma levels did not change significantly within and
between groups. In conclusion, sugar cane policosanol at a dose of 10mg/d showed no lipid lowering effects in
subjects with primitive, diet-resistant hypercholesterolaemia. [P3]

Francini-Pesenti F also reported another study on the effect of polycosanol, sugar cane, on lipid profile. In the study,
68 primary hypercholesterolemic subjects were enrolled and randomly assigned to the treatment or to the control
group. The first group received sugar cane policosanol 20 mg daily for 8 weeks, while the control group was treated
with placebo. All subjects followed a normocaloric diet. The content of policosanol, sugar cane, in the supplement
tablets was assessed by gas chromatography. A total of 32 subjects in the policosanol group and 31 subjects in the
control group completed the study. Body mass index, total cholesterol, HDL-cholesterol, LDL-cholesterol and
triglyceride plasma levels did not change significantly in either group. They concluded that sugar cane policosanol at
doses of
20 mg daily showed no lipid lowering effects in subjects with primary hypercholesterolemia. [P5]
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Policosanol is a mixture of primary aliphatic alcohols-tetracosanol, hexacosanol, heptacosanol, octacosanol,
nonacosanol, triacontanol, dotriacontanol and tetratriacontanol [Patent 5663156]. The manufacturing method for
policosanol include ethanol extraction and purification. Its melting point is 70-82C. Policosanol is insoluble in water. Most
clinical trials suggest policosanol may decrease cholesterol levels. Policosanol may help prevent atherosclerotic lesions
and cerebral ischemia in Mongolian gerbils.[1]

Early study about policosanol's effect on cholesterol level
In 1984, sugar cane wax was demonstrated to be able to lower lipid in rodents.[2,3] Later, another study demonstrated
that octacosanol (a policosanol) could lower triglyceride and cholesterol contents in the liver.[4] In 1987, a study
demonstrated that high doses of hexacosanol (a policosanol) had cholesterol lowering effects. [5] Thus, policosanol was
"suspected" to be able to benefit people with a high cholesterol profile.

In 1994, Cuban researchers reported that policosanol inhibited the cholesterol synthesis at early steps of cholesterol
biosynthetic pathway in a study of human lung fibroblasts. They also reported that policosanol lowered the total
cholesterol mainly through a decrease in LDL-C levels in a study of rabbits. They filed the first patent on the policosanol
composition.[6-8] In 1996, the Cuban researchers reported that oral policosanol could inhibit hepatic cholesterol
biosynthesis in rats.[9] Two years later, a group filed a patent on a composition containing policosanol to reduce serum
cholesterol levels.[10] Policosanol reduced cholesterol levels in patients suffered from type II hypercholesterolaemia.

In 2001, the Cuban researchers transferred fibroblast to a lipid-depleted medium to accelerate cholesterol synthesis.
Addition of policosanol retarded the cholesterol synthesis in a dose-dependent manner. [11]
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