Red yeast rice has been used for centuries in China as both a food and a medicinal product. 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 and aid digestive problems. The dietary supplement has also been used traditionally for bruised muscles, hangovers, indigestion, and colic in infants.

Recent research has shown that red yeast rice contains substances that are similar to prescription statin medications (such as atorvastatin, lovastatin, fluvastatin, simvastatin, pravastatin), which can lower cholesterol. Statins interfere with an enzyme that is responsible for cholesterol production in the body. There is also growing interest in evaluating red yeast rice for use as a natural food dye and preservative.

The use of red yeast rice in the United States today is controversial. Currently, the U.S. Food and Drug Administration (FDA) classifies red yeast as a dietary supplement. There is growing concern, however, that the supplement is actually being used as an unregulated medication. There is ongoing debate, therefore, about whether to reclassify red yeast rice as a prescription drug -- which would require much greater regulation of its use.

Prevention

Research has shown that red yeast Monascus purpureus inhibits the action of an enzyme in the body called HMG-CoA reductase, which is known to raise cholesterol levels. High cholesterol levels increase the risk of heart disease. Because of its inhibitory action on this cholesterol-raising enzyme, the therapeutic use of red yeast rice may potentially prevent and treat high cholesterol levels, promote blood circulation, and help lower the risk of heart disease. More study, however, is needed.

Treatment

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

• One recent study by the UCLA School of Medicine involved 83 people with high cholesterol levels. Those who received red yeast rice over a 12-week period experienced significantly lower levels of total cholesterol, LDL ("bad") cholesterol, and triglycerides (fatty substances that can also accumulate in the blood stream and damage the blood vessels) compared to those taking placebo. HDL ("good") cholesterol levels did not change in either study group.
• Two studies presented before the American Heart Association have shown benefit. In the first study, 187 people had mild-to-moderate elevations in total cholesterol and LDL cholesterol. The study showed 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 took red yeast rice had significant reductions in total cholesterol and LDL cholesterol levels compared to those who received placebo. Both studies treated the participants with the supplement or placebo for 8 weeks.
• In another 8-week study of 446 people with high cholesterol, those receiving red yeast rice had a significant drop in cholesterol their levels compared to those who took 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 cheese.

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

• Cholestin -- each capsule has 600 mg of red yeast rice.
• Herbalin Ruby Monascus -- each capsule has 500 mg of red yeast rice.

Pediatric

Labels on all red yeast rice products should note that people younger than 20 years should not use red yeast rice supplements.

Adult

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

• Standardized extract: use 600 mg (oral doses), two to four times daily.

Because there is little information about the safety of red yeast rice when used over an extended period of time, you should use red yeast rice for a short period of time if you do take the supplement.

People with liver disease and those at risk for liver disease should not take red yeast rice. Red yeast rice may affect liver function in the same way prescription cholesterol lowering medications can.

People who drink more than two alcoholic beverages a day, have a serious infection or physical disorder, or have undergone an organ transplant should also avoid using red yeast rice.

Side Effects

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

• Headache
• Stomach ache or bloating
• Gas
• Dizziness
• Heartburn
• Muscle aches and weakness

Pregnancy and Breastfeeding

The safety of red yeast rice during pregnancy and breast-feeding has not been evaluated. For this reason, until further information is available, pregnant or breast-feeding women should not use it.

Pediatric Use

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

Geriatric Use

To date, studies have not specifically investigated the safety of red yeast rice in older adults. However, elderly patients who were treated with 1,200 mg per day of red yeast rice in an 8-week study had no significant side effects.

Cholesterol-lowering medications

Red yeast rice should not be taken with cholesterol-lowering (statin) medications unless supervised by your doctor, because the supplement may enhance their effect, therefore increasing the risk of liver damage. If you are already taking a statin, talk to your health care provider before adding red yeast rice to your regimen.

Grapefruit juice

Grapefruit and grapefruit juice can enhance the effects of statins and significantly increase their blood levels, increasing the risk of side effects and liver damage. Because red yeast rice may act similarly in the body to statins, you should avoid drinking grapefruit juice or eating grapefruit or marmalade while taking red yeast rice.

Coenzyme Q10

Statins may deplete the coenzyme called CoQ10 from the body. CoQ10 is very important in heart and muscle health and in energy production. Side effects of CoQ10 depletion include fatigue, muscle aches and pains, and muscle damage. Red yeast rice also may deplete CoQ10 from the body. It is important to supplement your diet with CoQ10, 150 - 200 mg at night, while you are taking red yeast rice products, and for 4 weeks after you stop taking red yeast rice.

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