Red yeast rice has been used in China for centuries as both a food and as a medicinal substance. It is made by fermenting a type of yeast called Monascus purpureus over red rice. In Chinese medicine, red yeast rice is used to promote blood circulation, soothe upset stomach, and invigorate the function of the spleen, a body organ that destroys old blood cells and filters foreign substances. In addition, this dietary supplement has been used traditionally for bruised muscles, hangovers, indigestion, and colic in infants. Recently, it has been discovered that red yeast rice contains substances that are similar to prescription medications that lower cholesterol. There is also growing interest in evaluating red yeast rice for use as a natural food dye and/or preservative.

The overlap of red yeast rice use as both a medicine and a food in traditional Chinese practice is mirrored by a modern day controversy in the United States. Currently, red yeast rice is classified as a dietary supplement by the United States Food and Drug Administration (FDA); however, given its contents and function, there are many who feel that it is actually being used as an unregulated medication. There is ongoing debate, therefore, about whether to change the status of red yeast rice to a prescription drug—which would require much greater regulation.

Laboratory studies have shown that the Monascus purpureus inhibits the action of a body enzyme called HMG-CoA reductase, known to raise cholesterol which, in turn, increases the risk of heart disease. Because of this inhibitory action, red yeast rice's therapeutic uses include the prevention and treatment of high cholesterol.

Taking red yeast rice can help reduce and maintain healthy cholesterol levels and promote blood circulation, thereby lowering the risk of heart disease.

The following studies suggest that red yeast rice significantly reduces high cholesterol:

• Recently, the UCLA School of Medicine conducted a study involving 83 people with high cholesterol levels. Those who received red yeast rice over a 12-week period experienced a significant reduction in total cholesterol, LDL ("bad") cholesterol, and triglycerides (fatty substances that can also accumulate in the blood stream and cause damage to blood vessels) compared to those who received placebo. HDL ("good") cholesterol did not change in either group during the study.
• Two studies involving red yeast rice were presented at the American Heart Association's 39^th Annual conference in 1999. The first study, involving 187 people with mild to moderate elevations in total cholesterol and LDL cholesterol revealed that treatment with red yeast rice reduced total cholesterol by more than 16%, LDL cholesterol by 21%, and triglycerides by 24%. HDL cholesterol also increased by 14%. In the second study, elderly participants who were given red yeast rice experienced significant reductions in total cholesterol and LDL cholesterol compared to those who received placebo. Both studies treated the participants with the supplement or placebo for 8 weeks.
• In another 8-week trial involving 446 people with high cholesterol levels, those who received red yeast rice experienced a significant drop in cholesterol levels compared to those who received placebo. Total cholesterol fell by 22.7%, LDL by 31%, and triglycerides by 34% in the red yeast rice group. HDL cholesterol increased by 20% in the red yeast rice group as well.

Red yeast rice is used in powdered form as a food coloring in Asia and in Chinese communities in North America, most commonly for coloring fish, alcoholic beverages, and cheeses.

Red yeast rice is supplied as an ingredient in several commercially available combination supplement products that are marketed to promote heart health. Red yeast rice is also available in the following commercial preparations:

• Cholestin®—each capsule supplies 600 mg of red yeast rice
• Herbalin Ruby Monascus®—each capsule supplies 500 mg of red yeast rice

Labeling on all red yeast rice supplements state that individuals younger than 20 years should not use red yeast rice supplements. Following this recommendation seems safest at this time, as there is no additional information on children's dosage currently available in scientific literature.

In Traditional Chinese Medicine, the dosage of dietary or supplemental red yeast rice is as high as 6,000 to 9,000 mg per day, but the appropriate dosage for adults may vary, depending on the form of the supplement:

• Standardized extract: 600 mg (oral doses), 2 to 4 times per day has been used in scientific studies to date.

Because there is little information about the safety of red yeast rice when it is used over an extended period of time, it is best to limit its use to short term.

People who are at risk for liver disease, or currently have liver disease, should not take red yeast rice because, similar to prescription cholesterol lowering medications, red yeast rice may affect liver function.

Those who consume more than two alcoholic beverages per day, have a serious infection or physical disorder, or have undergone an organ transplant are also advised to avoid red yeast rice.

Side effects of red yeast rice are rare but can include:

• Headache
• Stomach ache and/or bloating
• Gas
• Dizziness
• Heartburn

The safety of red yeast rice during pregnancy and breast-feeding has not been evaluated. Until further information is available, it should be avoided in these cases.

Manufacturers recommend that people under age 20 should not be given this supplement until further information is available. There is currently no scientific information indicating whether red yeast rice can be safely given to children.

To date, studies have not specifically investigated the safety of red yeast rice in elderly people. However, elderly patients treated with 1,200 mg per day of red yeast rice in an 8-week trial experienced no significant side effects.

Cholesterol-Lowering Medications

Red yeast rice should not be taken with cholesterol-lowering (statin) medications known as HMG-CoA reductase inhibitors (such as atorvastatin, lovastatin, fluvastatin, simvastatin, pravastatin, cerivastatin), because it may enhance the effect of these medications, thereby increasing the risk of liver damage.

Grapefruit Juice

When grapefruit or grapefruit juice is taken with HMG-CoA reductase inhibitors such as atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, and simvastatin, they enhance the effects of the medications and cause a significant increase in blood levels of these synthetic drugs, leading to a greater chance of side effects and liver damage. Because red yeast rice appears to act in much the same way as these cholesterol-lowering drugs, it would be wise to avoid drinking grapefruit juice or eating grapefruit or grapefruit products such as marmalade while taking red yeast rice.

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