In clinical trials, red yeast rice has lowered cholesterol effectively, David J. Becker, MD, said recently at the 58th Annual Scientific Session of the American College of Cardiology in Orlando, Fla. But in an analysis of 12 red yeast rice products performed by ConsumerLab, 4 were found to contain citrinin at levels that varied from 24 to 189 parts per million.

Active constituents of red yeast rice products include monacolins, which ranged per 600-mg capsule from 0.31 mg to 11.15 mg. Per capsule, the amount of monacolin K, the active cholesterol-lowering compound identical with lovastatin, ranged from 0.10 mg to 10.99 mg. Two formulations were compared for effectiveness in lowering low-density lipoprotein (LDL) in 68 hyperlipidemic patients, who took 4 to 6 capsules/day.

The manufacturers of the formulations were N3 Oceanic, Inc., in Palm, Penn., and Sylvan Bioproducts, Inc., in Kennett Square, Penn.

Neither product contained citrinin, said Becker, a cardiologist at Chestnut Hill Cardiology in Flourtown, Penn. After 12 weeks, LDL cholesterol decreased a mean of 42 percent from baseline (P <.0001) in patients who took the N3 Oceanic brand and by a mean of 27.3 percent from baseline (P <.001) in those who took the capsules manufactured by Sylvan.

Myalgias forced discontinuation by two patients who took the capsules made by N3 Oceanic.

 Becker called for better oversight and standardization of red yeast rice products and advised that the products be used with caution until that time.

Wayne Kuznar is a clinical writer in Cleveland, Ohio.