A Substitute for Those Who Can't Take Statins?

ByABC News
June 15, 2009, 6:02 PM

June 16 -- MONDAY, June 15 (HealthDay News) -- A new study revives a running controversy about the purported cholesterol-lowering effects of the centuries-old natural product called red yeast rice.

Red yeast rice is produced when a yeast, Monascus purpureus, is grown on rice. It has been used in Asian countries for more than a thousand years as food and medicine. In the United States and Europe, it has been proposed as an alternative cholesterol-lowering treatment for people who cannot take statins because of severe side effects, mainly muscle wasting and weakness.

The new study, from physicians in Pennsylvania and reported in the June 16 issue of the Annals of Internal Medicine, found a significant cholesterol-lowering effect of a commercially available nonprescription red yeast rice product in a small group of such people.

The study included 62 people who stopped taking statins because of side effects. All of them followed a lifestyle change program, including education on nutrition, exercise and relaxation techniques. Half also took 1,800 milligrams twice a day of a red yeast rice product for 24 weeks, while the others took an inactive substance.

"In the group that took red yeast rice, the average drop in cholesterol was 43 points at 12 weeks," said Dr. Ram Y. Gordon, a cardiologist in private practice who was a member of the research group. "The drop in the placebo group was only 11 points. In the longer run, the drop was 35 versus 15 points. We think the difference narrowed because after 12 weeks we told people to keep on doing it, but maybe some stopped."

There are, however, complications related to the product. Red yeast rice is under a regulatory cloud at the U.S. Food and Drug Administration because it contains a natural statin, lovastatin, sold as a prescription drug named Mevacor. The FDA moved against several red yeast rice products -- not the one used in the Pennsylvania study -- on the grounds that they were unlicensed pharmaceuticals, a move which was upheld after a court tussle.