A 24-week study of the effects of red yeast rice on the cholesterol levels of people who cannot take statins shows that the ancient Asian food could be a viable statin alternative.
Patients who took 1,800 mg of a commercially available red yeast product twice daily enjoyed a long-term drop of 35 points in their cholesterol levels, versus 15 points for patients taking a placebo.
Red yeast rice is rice that has been grown with a yeast, Monascus purpureus, on it. Asians have used it for centuries as both a food and a medicine. European and American scientists have long believed that it has significant cholesterol-lowering abilities.
The study’s designers, a group of Pennsylvania physicians, looked at 62 patients who had been forced to stop taking statins because of such side effects as weakness and muscle wasting.
Statins, which are typically prescribed for people who run a high risk of cardiovascular disease, are a class of drugs that lower cholesterol in the blood by inhibiting an enzyme involved in its production. A significant drawback to statins is their potential to cause liver damage in some patients.
Although the study results were encouraging, several issues have to be addressed before red yeast rice joins the pharmacopeia as a prescription for lowering cholesterol:
- The study group was too small to provide more than a confirmation that a bigger group of patients will have to be studied.
- Supplies of red yeast rice in the United States are not reliable or consistent.
- The FDA has concerns that one of the natural statins contained in red rice yeast, lovastatin, is the basis of an already existing prescription drug called Mevacor. Therefore, many red yeast rice products are unlicensed pharmaceuticals whose sales the agency has successfully been able to thwart in the wake of a court case.
The specific red yeast rice product used in the study is not under the FDA’s scrutiny because it contains such a low level of lovastatin-1 part in 600. Study participants ingested only 6 mg of lovastatin daily, too little to account for the red yeast rice’s cholesterol-lowering powers. The researchers think that the beneficial effect may have come from up to 10 other compounds in the red yeast rice that are closely related to lovastatin.
Three people in the study reported side effects, such as liver problems and muscle pain. Two were taking the red yeast rice and the third was taking the placebo. None of the side effects, says Dr. Ram Y. Gordon, a member of the research group, was severe.
The next step will be tracking a larger group of patients to see if the Pennsylvanian results can be duplicated. In the meantime, doctors who were involved with the study, as well as physicians who treat patients for side effects from statins, say that doctors should not prescribe red yeast rice products, and high-cholesterol patients should not self-medicate with them.