|FDA Warning:||Some red yeast rice products may contain an unauthorized drug called lovastatin (Altoprev, Mevacor). 17,18 Lovastatin is a prescription medicine used to treat high cholesterol. Because of the risk of potential health problems, the Food and Drug Administration (FDA) has banned red yeast products that contain lovastatin. These include: Red Yeast Rice and Red Yeast Rice/Policosonal Complex (sold by Swanson Healthcare Products) and Cholestrix (sold by Sunburst Biorganics). For more information, read the FDA's warning .|
Red yeast rice is a traditional Chinese substance made by fermenting a type of yeast called Monascus purpureus over rice. Various formulations of this product have been used in China since at least 800 AD as a food and also as a medicinal substance within the context of Traditional Chinese Herbal medicine . This ancient preparation contains naturally occurring substances similar (and, in some cases, identical) to cholesterol-lowering prescription drugs in the “statin” family.
Red yeast rice is thought to be effective for lowering cholesterol, presumably because of its statin constituents. There is evidence to support this use.
An 8-week, double-blind, placebo-controlled trial of 83 people with high cholesterol evaluated red yeast rice. 1 At the end of the 8-week treatment period, levels of total cholesterol decreased significantly in the red yeast rice group as compared to the placebo group. Benefits were also seen in LDL (“bad” cholesterol) and triglycerides as well. No significant differences were noted in HDL (“good” cholesterol) levels from baseline or between groups. In an 8-week study of 79 people, use of red yeast rice was noted to improve the LDL/HDL ratio, along with several other measures of cardiac risk. 9,11
In a carefully conducted review of 93 randomized trials involving almost 10,000 patients, researchers concluded that red yeast rice can significantly lower levels of total cholesterol, LDL, and triglycerides, and raise levels of HDL compared with placebo. 13 Similarly, in a subsequent review of 22 trials, researchers concluded that an alcohol extract of red yeast rice (called xuezhikang) was no more or less effective than statins in lowering levels of cholesterol and triglycerides in people with high cholesterol and/or high triglycerides. 19 They also found that the supplement may be more effective than inositol nicotinate (another cholesterol-lowering medication) in reducing cholesterol levels.
A double-blind study performed in China compared an alcohol extract of red yeast rice (xuezhikang) against placebo in almost 5,000 people with heart disease. 10 Over a 4-year study period, use of the supplement reportedly reduced heart attack rate by about 45% as compared to placebo, and total mortality by about 35%. However, these levels of reported benefit are so high as to raise questions about the study’s reliability. At least 3 other studies, all from this same original population of participants, have found similar results in diabetics with heart disease 14 and in patients with previous heart attack, 15,16 with surprisingly large reductions in the rates of coronary events (eg, heart attack) and mortality. These levels of reported benefit, however, are so high and so similar as to raise questions about their reliability.
Because red yeast rice is essentially a drug supplied by a natural product, and this drug has many potential side effects , we suggest that it should be used only under physician supervision.
The dosage of red yeast rice used in most studies is 1.2 to 2.4 g of red yeast rice powder daily. However, due to patent-infringement suits by the manufacturer of a statin drug that is naturally present in red yeast rice, the most studied red yeast rice product has been taken off the market, and it is not clear whether the remaining products have greater or lesser potency. Note : The herb St. John’s wort is known to reduce the effectiveness of drugs in the statin family. 12 There is every reason to believe it would have the same effect on the action of red yeast rice.
In clinical trials, use of red yeast rice has not been associated with any significant side effects. However, red yeast rice contains naturally occurring statin drugs, and use of statin drugs can cause side effects ranging from minor to life-threatening. Some of the most common include muscle pain, joint pain, liver inflammation, and peripheral nerve damage; severe breakdown of muscle tissue (rhabdomyolysis) leading to kidney failure has also occurred. It is almost certain that red yeast rice can cause the same problems if it is used by enough people, and there are at least two case reports in the literature of muscle injury caused by red yeast rice; in one case, rhabdomyolosis developed. 2,3 Due to the relative lack of regulation of supplement manufacture, the statin content of red yeast rice products is unpredictable, and this could increase potential risk. In addition, red yeast rice may at times contain the toxic substance citrinin. 4
Based on the known effects of statins, pregnant or nursing women, women likely to become pregnant, young children, and people with liver or kidney disease should not use red yeast rice. Furthermore, red yeast rice should not be combined with fibrate drugs , cyclosporine , erythromycin-family drugs, antifungal drugs, or high-dose niacin . Finally, it would not make sense to combine red yeast rice with standard statin drugs.
Statin drugs are known to interfere with the body’s ability to produce the natural substance CoQ 10 , 5-7 and one animal study found the same effect with red yeast rice. 8 For this reason, people taking red yeast rice could conceivably benefit from CoQ 10 supplementation; however, this has not yet been proven. (See the full article on Statins for more information.)
If you use red yeast rice to keep your cholesterol levels down, taking the herb St. John’s wort may impair the effectiveness of red yeast rice and cause your cholesterol to rise.
10. Du BM, Lu ZL, Chen Z, et al. The beneficial effects of lipid-lowering therapy with Xuezhikang on cardiac events and total mortality in coronary heart disease patients with or without hypertension: a random, double-blinded, placebo controlled clinical trial. Zhonghua Xin Xue Guan Bing Za Zhi . 2006;34:890-894.
12. Andren L, Andreasson A, Eggertsen R. Interaction between a commercially available St. John's wort product (Movina) and atorvastatin in patients with hypercholesterolemia. Eur J Clin Pharmacol. 2007 Aug 15. [Epub ahead of print]
14. Zhao SP, Lu ZL, Du BM, et al. Xuezhikang, an extract of cholestin, reduces cardiovascular events in type 2 diabetes patients with coronary heart disease: subgroup analysis of patients with type 2 diabetes from China coronary secondary prevention study (CCSPS). J Cardiovasc Pharmacol. 2007;49:81-84.
15. Ye P, Lu ZL, Du BM, et al. Effect of xuezhikang on cardiovascular events and mortality in elderly patients with a history of myocardial infarction: a subgroup analysis of elderly subjects from the China Coronary Secondary Prevention Study. J Am Geriatr Soc. 2007;55:1015-1022.
16. Lu Z, Kou W, Du B, et al. Effect of xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction. Am J Cardiol. 2008;101:1689-1693.
17. FDA warns consumers to avoid red yeast rice products promoted on internet as treatments for high cholesterol products found to contain unauthorized drug. US Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108962.htm . Published August 9, 2007. Accessed October 3, 2011.
18. Red yeast rice. US Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153116.htm . Published August 9, 2007. Accessed October 3, 2011.
Last reviewed September 2014 by EBSCO CAM Review Board
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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