Red Yeast Rice (RYR) has been consumed in parts of China for more than 1000 years. In the USA it is perhaps best known as the substance that provides Peking duck with its characteristic red coloring. RYR has also been used as a traditional treatment for circulatory problems in China. In the USA RYR has become a popular treatment for elevated serum cholesterol level.
For the past several decades many studies have confirmed that RYR lowers LDL-cholesterol levels.1 However, controversy arose about 10 years ago when researchers found that popular RYR supplements such as Cholestin contained lovastatin, a patented and FDA approved cholesterol-lowering drug sold by Merck as Mevacor. RYR has also been shown to contain a variety of other phytochemicals with statin-drug-like properties. The FDA banned the sale of RYR, which contained "lovastatin". RYR products sold today according to the FDA are supposed to have their naturally occurring lovastatin removed, but recent testing shows most still contain about 1mg of "lovastatin" per 600mg capsule. Typically RYR supplement dosages run from about 1200 to 1800mg providing about 2-3mg of lovastatin and perhaps a little more of other statin-like substances. By contrast, the usual starting dose for Mevacor and now also the generic version of lovastatin is about 20mg with available dosages ranging from 10 to 80mg.
A recent small study of 25 people who stopped prescription statin drugs because of muscle pain and weakness or other adverse effects suggests RYR may be less likely to cause adverse effects than prescription statin drugs. Dr. Thompson at the University of Connecticut collected data on people who were taking RYR products they purchased on their own for 4 or more weeks. He found retrospectively that on average RYR supplements had lowered their LDL-C level by 21% while causing no muscle pain or other significant adverse side effects.2 Another group of researchers conducted a doubleblind, placebo controlled clinical trial in about 60 people in the Philadelphia area who had also abandoned prescription statin drugs because of muscle soreness. The subjects in this study took either 600mg of RYR 3 times daily or a look-a-like placebo for 24 weeks. Two subjects in the RYR group and one in the placebo group stopped taking their capsules because of reported muscle soreness. LDL-C levels dropped more than 25% in the first RYR group after 12 weeks but less than 7% in the control group.3 Muscle soreness/ weakness (known as myocytis) is the most commonly reported adverse effect associated with prescription statins, effecting up to 10% of all patients. These patients are often left with few good medical alternatives. Prescription drugs such as Zetia, fibric acid derivatives, and/or resin appear to be less safe and efficacious than RYR. Data from these two studies shows for the vast majority of patients who must stop prescription statin drugs because of myocitis taking RYR significantly lowers LDL-C levels without triggering a return of myocytis.
A large randomized trial in China compared the effects of either a crude RYR extract to a placebo over an average follow-up period of 4.5 years. Not only did this RYR extract significantly improve blood lipids but more importantly it was shown to significantly reduce the coronary artery disease events by 45% and total mortality by 33%. The authors of this study concluded ".... long term therapy with [the RYR extract] significantly decreased the recurrence of coronary events and the occurrence of new CV events and deaths, improved lipoprotein regulation, and was safe and well tolerated."4
The FDA continues to approve the use of drugs to treat dyslipidemia with far less safety and demonstrated efficacy of RYR and RYR extracts. The FDA's partial ban on such natural products as RYR and its extracts appears more motivated by zeal to protect the financial interests of big pharmaceutical companies than assuring Americans have access to well regulated, safe, and effective nonproprietary therapeutic products.
By James J. Kenney, PhD, RD, FACN
1. Heber D, et al. Cholesterollowering effects of a proprietary Chinese red-yeast-rice dietary supplement. Am J Clin Nutr 1999;69:231-6fs
2. Venero JV, et al. lipid lowering efficacy of red yeast in a population intolerant to statins. Am J Cardiol 2010;105:664-6
3. Becker DJ, et al. Red yeast rice for dyslipidemia in statinintolerant patients. Ann Intern Med 2009;150:830-9
4. Kuo W. et al. Effect of XZK, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction. Am J Cardiol 2008;101:1689-93
Stephanie Ronco has been editing in a professional capacity for the past 10 years. In addition to her work as an editor, Ronco has also served as a ghostwriter and writing tutor. A voracious reader, Ronco loves watching language evolve and change. When she’s not delving into her latest project, Ronco can be found teaching acting classes, performing in community theater, or sailing with her husband.