People who took red yeast rice supplements and completed a 12-week lifestyle intervention program experienced bigger reductions in LDL "bad" cholesterol than patients who completed the same lifestyle program but took placebo pills.
Differences in Concentrations of Red Yeast Rice
And the study authors caution that since nutritional supplements are not regulated in the same way that prescription and over-the-counter drugs are, consumers can't always be certain of the quantity and quality of the products they buy.
Study co-author Ram Y. Gordon, MD, tells WebMD that when his research team had 12 different brands analyzed, they found a 100-fold difference in the concentrations of red yeast rice.
Gordon cited a separate analysis of red yeast rice products, in which four of 12 contained a toxin known as citrinin, which can harm the kidneys.
"Most of the brands say they contain 600 milligrams of red yeast rice per capsule, but that may or may not be true," Gordon says. "Red yeast rice may have great potential for people who can't or won't take statins. However, until it is better regulated and has better oversight by the FDA, we can't recommend it."
Used medicinally by the Chinese for centuries, red yeast rice is derived from a fungus that grows on rice. It contains compounds collectively known as monacolins, which inhibit the formation of cholesterol. One monacolin called monacolin K is a natural form of statins. The researchers write that the dose of red yeast rice used in their study was equal to a daily dose of 6 milligrams a day of Mevacor. The usual dose of Mevacor for cholesterol treatment is 20 milligrams to 40 milligrams a day.
The newly published study included 62 people with high LDL cholesterol who had stopped taking statins because of muscle pain.
Half the study participants took three 600-milligram capsules of red yeast rice a day and half took placebo capsules that were identical in look and smell to the red yeast rice. And both treatment groups were enrolled in a 12-week lifestyle program, which included once-a-week, three-hour educational sessions encompassing diet, exercise, and stress management.
The red yeast rice supplements used in the study were independently analyzed to ensure that the dosage was accurate.
Red Yeast Rice vs. Placebo
After six months, patients who took the red yeast rice had lowered their LDL cholesterol by an average of 35 mg/dL, compared to 15 mg/dL among the placebo group.
The study appears in the latest issue of the journal Annals of Internal Medicine.
Cardiologist Robert Eckel, MD, runs a lipid clinic at the University of Colorado and is a past-president of the American Heart Association. He tells WebMD that statin-related muscle pain is a common problem that has not received enough attention.
Eckel says muscle pain issues often resolve when patients are switched to a different statin or when dosages are lowered. There are also non-statin drugs that lower cholesterol, such as the cholesterol-blocker Zetia.
"It isn't clear if the patients in this study were taking very large doses of statins," he says. "If they were, their muscle pain might have gone away with lower doses or by switching to a low-end statin."