Results from a large randomized trial conducted in China, published in the American Journal of Cardiology, show that, in patients with prior myocardial infarctions (heart attacks) who were given an extract made from red yeast rice, the risk of having another heart attack and the risk of dying were reduced by nearly 50%.
In the Chinese Coronary Secondary Prevention Study, nearly 5,000 heart attack survivors received either Xuezhikang (XZK, a red yeast rice extract) or placebo in a double-blinded randomized clinical trial -- neither the patient nor the doctors knew which substance individual patients received. After an average of 4.5 years, patients receiving XZK had a 45% relative reduction in heart attacks and in death.
The XZK extract from the red yeast rice contains several compounds, but the predominant one is lovastatin, a statin drug marketed in the United States as Mevacor and Altocor. Lovastatin is thought to explain most of the beneficial results seen with this study, but whether it is the sole explanation or whether some of the other components of XZK are playing a role is currently unknown.
Red yeast rice in the United States
Thanks to the FDA and the federal courts, there has been a lot of confusion about the red yeast rice products available in the United States. In the late 1990s, studies showed that this over-the-counter dietary supplement was quite effective at reducing cholesterol levels, mainly because one of the natural ingredients in red yeast rice turned out to be lovastatin. (Statins were originally derived from yeast products; the lovastatin in red yeast rice is "natural.") When the FDA figured out that red yeast rice contained a regulated substance, an effective drug protected under patent law, it banned red yeast rice products, unless manufacturers took extra steps to remove the lovastatin.
The question of whether the red yeast rice products available in the United States over the past decade have actually been allowed to contain lovastatin or not is remarkably complex. The bottom line is that for the past several years, lovastatin-containing red yeast rice is clearly illegal. You can read about lovastatin, red yeast rice and the feds here. Nonetheless, as recently as the summer of 2007, the FDA issued "warnings" that certain over-the-counter red yeast rice products from at least two companies still contained lovastatin and announced that it was taking immediate steps to remove these illegal products from the shelves.
The bottom line:
Several randomized trials now show that unadulterated red yeast rice, or the XZK extract from red yeast rice, can substantially reduce cholesterol levels and/or reduce cardiac risk in high-risk patients, and the most likely explanation for this benefit is that these effective red yeast rice products contain a statin.
Judging from the scores of communications I have received over the past few years, many readers of this site are spending a fair amount of effort trying to find sources for the "real deal": unadulterated red yeast rice, fully loaded with lovastatin, that has escaped the FDA's scrutiny. (Note to readers: I have no idea whatsoever where to find such stuff as this, and if I did know -- not wanting to go to jail -- I could not tell you.) It is virtually impossible for a consumer to know whether or which red yeast rice products sold in the United States still contain lovastatin. Apparently some still might, despite a decade of efforts by the FDA to eliminate such products. Any that do contain lovastatin are illegal.
So here's a suggestion: Instead of wasting your time and money looking for something which you can never really know you have found, why not talk to your doctor about generic statins? At least three are now available (lovastatin, pravastatin and simvastatin), and they are not much more expensive than red yeast rice. As a bonus, the statin dosage is actually known (unlike with "natural" red yeast rice) and can be logically adjusted to optimize your results. And think of all the gas you'll save by not having to drive to 20 to 30 stores to find the last few bottles of effective red yeast rice before the feds do.
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.