TUESDAY, May 16, 2006 (HealthDay News) -- Countering previous research, a new study found that the nutritional supplement policosanol wasn't any more effective at lowering cholesterol than a placebo.
"Policosanol had no effects on blood lipids beyond placebo, not even with very high doses," said study author Dr. Heiner Berthold, a professor of clinical pharmacology at the University of Cologne, and executive secretary of the Drug Commission of the German Medical Association, in Berlin.
Policosanol is a natural supplement, commonly derived from sugar cane wax. It can also be made from wheat germ, beeswax and rice bran. Policosanol made from Cuban sugar cane is sold commercially in dozens of countries, according to background information in the article. Along with its purported cholesterol-lowering effects, the supplement is also supposed to have antioxidant action and to help keep blood from clotting.
While there have been many positive studies documenting policosanol's cholesterol-lowering abilities, the article points out that most of this research was done by a single research group in Cuba.
Because of this, the German research group involved in this study felt there was a need for independent confirmation of the positive findings.
So, they recruited 143 people from 14 different centers in Germany. Then, they randomly assigned the study volunteers to five different treatment groups. Twenty percent received a placebo, and the remaining 80 percent were divided into four treatment groups that received either 10, 20, 40 or 80 milligrams of policosanol daily for 12 weeks.
The average total cholesterol for the study volunteers was 275 mg/dl. According to the American Heart Association, a level under 200 mg/dl is desirable. Above 240 mg/dl is considered high risk. The average LDL -- or bad cholesterol -- was above 180 mg/dl for the study participants. The AHA classifies anything above 160 mg/dl as high.
The researchers found the supplement was well tolerated, but, at the end of 12 weeks, there was no statistically significant difference in cholesterol levels between the groups.
Results of the study appear in the May 17 issue of the Journal of the American Medical Association.
The bottom line, according to Berthold, is, "Don't waste your money for drugs with no proven effects. Don't forget that there are drugs with proven effects (statins)."
Dr. Louis Teichholz, division director of cardiology and chief of complementary medicine at Hackensack University Medical Center in New Jersey, isn't as quick to dismiss policosanol, although he doesn't recommend it, either.
"I usually tell my patients that there's currently no data to support its use," he said. "But, it is safe and really has no significant side effects. Right now, I'm going to keep an open mind, because maybe it's effective in some groups of people."
Teichholz is currently involved in research on the use of policosanol in people with lower cholesterol levels, which he said was his only criticism of the new study.
"The cholesterol levels [of study participants] were extremely high. They were high enough that in the U.S., most of these patients would be considered for statin therapy. Generally, if you want to target someone who wants to use non-pharmaceuticals, it would be someone with mild elevations," he said, but added that this study definitely raises concerns about the use of policosanol for cholesterol reduction.
Teichholz also pointed out that the new study was comprised only of whites and a majority of women -- 61 percent -- which might have had an effect on the study's findings.
Berthold said he didn't think the study population made a difference. He said past research hasn't shown significant differences between ethnic groups and their responses to medications.
What has been proven to lower cholesterol, said Berthold, is statin medications.
"Statins can lower cholesterol as much as 50 percent or more. Statins have been shown to prevent heart attacks and even prolong life," he said.
He added that quitting smoking and controlling high blood pressure and obesity can also lower cholesterol. Additionally, plant stanols, which are found in products such as margarine, can help lower cholesterol a bit, according to Teichholz.
For mild cholesterol elevation, Teichholz said a healthy diet that's high in fiber may help.
To learn more about cholesterol, visit the American Academy of Family Physician's Web site.