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Policosanol for cholesterol reduction

Clinical trial
Results
Comment

Policosanol is a mixture of long chain alcohols, principally from sugar cane wax, but obtainable from other plant sources. Cuban cane sugar policosanol is sold in more than 40 countries, and was described not so long ago as one of the fastest growing complementary therapy products.


In theory this wonder stuff works like plant stanols we find in margarines and other products. It is claimed to reduce lipid levels, producing major reductions in LDL cholesterol (by 25% or so) and total cholesterol (by 13%), as well as increasing HDL cholesterol by 12%.

The only fly in this particular ointment is that all the very considerable clinical trial results have come from a single source in Cuba. A single study with wheat germ policosanol showed no effect. There is a Bandolier review on this from January 2005 downloadable from the Internet site. Figure 1 shows the amazingly consistent results in total cholesterol reduction for policosanol from Cuban sugar cane, and the single trial of wheat germ policosanol. These trials used policosanol doses of 2 to 40 mg a day, mostly about 10 mg a day, over periods from one to 12 months.


Figure 1: Percentage reduction in total cholesterol with policosanol in Bandolier review. Filled circle is wheat germ policosanol






What was missing was an independent trial of Cuban policosanol. We now have it [1]. Readers are invited to guess the result before reading on.

Clinical trial


The trial randomised 143 patients with high lipid levels to placebo or 10, 20, 40 and 80 mg policosanol daily for 12 weeks. The policosanol was supplied from Cuba and encapsulated in Germany. Blood samples were collected initially after a placebo run in period, and at six and 12 weeks after the start of treatment.

Results


The average age of patients was in the mid-50s, with BMI of about 27, and slightly more women than men. The trial was completed by 94% of patients, and adherence was measured at close to 100%. Initial concentrations were total cholesterol 7.3 mmol/L, LDL cholesterol 4.8 mmol/L, and HDL cholesterol 1.3 mmol/L.

There were no significant differences for any of the lipoprotein measures between baseline and the 12-week sample for any dose of policosanol or placebo, nor any difference between policosanol and placebo. Results for percentage change of 12 weeks for total and LDL cholesterol are shown in Figure 2. There was no better response at higher doses.


Figure 2: Percentage reduction in total and LDL cholesterol over 12 weeks with placebo and increasing daily doses of Cuban cane sugar policosanol






Comment


Now we have an independent clinical trial from outside Cuba. The result is a profound negative. Is it possible that all those Cuban trials are right and the two European ones are wrong? Or is it more likely that the trials from the group promoting policosanol, with the staggering uniformity of results shown in Figure 1, in some way overstates the case?

This is big business. Try typing policosanol into a search engine and see what you find: hundreds of thousands of sites, many trying to sell you the stuff. Any reputable regulatory agency would immediately close down any outfit trying to flog this to unsuspecting customers. And for the argument that it is safe, ask yourself whether trials with dubious efficacy measures can be trusted to report harm accurately. Think of the furore if a pharmaceutical company was allowed to market an ineffective medicine with no safety data.

Reference:

  1. HK Berthold et al. Effect of Policosanol on lipid levels among patients with hypercholestrolemia or combined hyperlipidaemia. JAMA 2006 295: 2262-2269.

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