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May 16, 2006 -- The supplement policosanol may not live up to its cholesterol-cutting claims, according to a new study.
The study appears in The Journal of the American Medical Association. The researchers included Heiner Berthold, MD, PhD, of the Drug Commission of the German Medical Association.
Berthold's team tested policosanol made in Cuba from sugar cane wax. Policosanol is also made from wheat germ, rice bran, and beeswax; most policosanol ads tout lipid-lowering effects, write Berthold and colleagues.
The study's bottom line: Policosanol was well tolerated but showed no effects on cholesterol or blood fats in adults with high cholesterolhigh cholesterol or combined hyperlipidemia (too much fat or lipids in the blood).
Participants, Supplements
Participants were 143 white adults living in Germany. They all had high cholesterol or combined hyperlipidemia (too much fat or lipids in the blood).
First, the researchers asked participants to go on a low-cholesterol diet. Six weeks later, they split participants into five treatment groups:
The pills were taken once daily with the evening meal.
Participants took those pills -- while staying on the low-cholesterol diet -- for 12 weeks. They also periodically provided blood samples after overnight fasts and kept food diaries for part of the study.
About the Supplements
The supplements came from a Cuban company that had sponsored past studies, most of which were done in Cuba, that showed positive cholesterol effects for policosanol.
The German study had different results.
None of the five groups had more than a 10% drop in LDL "bad" cholesterol levels during the study, the researchers report. Policosanol also didn't show any significant changes in other cholesterol and blood fat categories, including total cholesterol, HDL "good" cholesterol, and triglyceridestriglycerides.
In short, the policosanol supplement didn't beat the placebo.
No Serious Side Effects Seen
Policosanol was "well tolerated" and, like the placebo, showed no serious side effects during the study, the researchers note.
The most commonly reported adverse effects during the study were bronchitisbronchitis, back painback pain, sore throatsore throat, upper respiratory tract infection, and upset stomach, with no differences seen between the policosanol and placebo groups.
Policosanol has also shown an "excellent" safety profile in other studies, write Berthold and colleagues. However, they say more studies are needed to check policosanol's safety and effectiveness.
"Still, more independent studies are required to counterbalance the vast body of available positive trials," the researchers write.
Berthold's team notes that while policosanol has been used for "more than a decade in clinical trials, there are still no data on patient outcomes" such as death and illness due to cardiovascular problems.
The study was funded by a German company that made the placebo. That company, Madaus AG -- along with its subsidiaries -- doesn't make or distribute any lipid-lowering drugs, including statins, the journal notes.
SOURCES: Berthold, H. The Journal of the American Medical Association, May 17, 2006; vol 295: pp 2262-2269. News release, JAMA/Archives.