Red Yeast Rice and Cholesterol (cont.)
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How safe are red yeast rice products?
Animal studies have been conducted in China using high doses of red yeast rice products. No damage to the kidneys, liver, or other organs were demonstrated in these studies.
Human trials in China and in the United States reported only rare and minor side effects of heartburn or indigestion with the use red yeast rice products. No liver, kidney, or muscle toxicity has been reported.
However, human trials in the United States and China have generally lasted only a few weeks to a few months. Thus, conclusive proof of long term safety (over a period of many years) will have to await further data (such as from data received after the products have been marketed or long-term clinical trials).
Scientists conducting the studies generally believe that red yeast rice is safe in the long-term since it has been a food staple for thousands of years in Asian countries without reports of toxicity. They attribute the safety of red yeast rice products to the process of preparation that does not involve the isolation and concentration of a single ingredient. Although it is true that isolation and concentration enhance the potency of a single ingredient, these factors also increase the risk of side effects.
Are there any precautions in consuming red yeast rice products?
Not all red yeast rice products contain the same concentrations of the cholesterol-lowering ingredients. Moreover, it is illegal in the United States to sell red yeast rice products that contain more than trace amounts of cholesterol lowering substances. Therefore, the red yeast rice products that are available in the United States do not contain levels of cholesterol lowering substances that are likely to cause side effects. Nevertheless, certain products also may contain unacceptably high levels of an undesirable and toxic substance called citrinic acid.