Virtual Mentor. June 2011, Volume 13, Number 6: 365-368.
The Lipid-Lowering Properties of Red Yeast Rice
Red yeast rice is an over-the-counter supplement, long used in China, that has shown lipid-lowering effects in trials. It has become popular among Americans but, until regulation and standardization improve, its use will remain controversial.
David J. Becker, MD, and Ram Y. Gordon, MD
When I saw Mr. S in my office 9 years ago, he had high cholesterol, with a low-density lipoprotein cholesterol (LDL-C) of 180 mg/dl, so I started him on statin therapy. Six months later, his lipids were significantly improved and I tried to renew his prescription for atorvastatin. He gave me a sly grin and told me that he had stopped taking it. Instead, he was taking red yeast rice, an over-the-counter herbal medication he had heard about on a local radio station. I had never heard of this supplement, but when several more patients related almost identical stories, I began to listen to them. It seemed to work especially well in patients who developed myalgias, or muscle aching, after they took statins, which occurs in up to 15 percent of patients in clinical practice. It was well-tolerated and seemed to lower cholesterol almost as well as conventional therapy.
Red yeast rice, used in China since 800 CE as a food colorant and medication, is made by culturing a yeast, Monascus purpureus, on rice. It is widely available and popular; sales of red yeast rice in the United States totaled $20 million in 2008 . Still, I was quite reluctant to recommend it to my patients. Many physicians have appropriate concerns about using over-the-counter products that have not been rigorously evaluated in double-blinded randomized controlled trials. The small studies that have been conducted are often funded by the manufacturer of the supplement, presenting a conflict of interest. Yet our patients are taking more and more supplements; the nutraceutical market in the U.S. has grown to $15 billion over the past few years. Patients often do not tell their physicians that they taking supplements, and this can lead to adverse drug interactions with prescribed medications. For example, products made from the herb St. John’s Wort, commonly used for depression, can significantly alter the lipid-lowering effect of statins, including rosuvastatin, making it dramatically less effective .
As a preventive cardiologist in private practice, I have an interest in intensive lifestyle modification programs and have led such a program for 16 years. Based on my clinical observations about the possible efficacy of red yeast rice, one of my partners and I decided to design a trial evaluating the lipid-lowering effects of both lifestyle changes and supplements. This involved an unusual twist for a cardiologist in private practice—getting internal review board approval for the study, recruiting patients, and obtaining funding.
After securing grants from the Commonwealth of Pennsylvania and other sources, we designed and conducted several randomized controlled trials evaluating the efficacy and safety of red yeast rice in different populations with hyperlipidemia. The studies were all funded by independent sources with no industry involvement. We examined the effects of lifestyle changes (education, diet, exercise, and stress management) on lipids and compared red yeast rice’s lipid-lowering effect to that of a placebo. We added other lipid-lowering supplements, fish oil and phytosterols, to red yeast rice, to evaluate their combined effects. We also tested our theory that red yeast rice might be better tolerated than statins in patients who had developed statin-associated myalgias. Our work on red yeast rice exemplifies how a supplement used by many patients can be rigorously studied and evaluated for efficacy and safety.
Despite these trials, the use of these products remains controversial for the following reasons:
The recent trials involving red yeast rice have led to the following conclusions:
In conclusion, red yeast rice is an over-the-counter supplement that has been used in China for centuries and has lipid-lowering effects. More recently, it has become popular among Americans, who often view it as an alternative to statins. Unlike most herbal supplements, it has been fairly well-studied and shown to be effective and safe in several randomized placebo-controlled clinical trials . For this reason, it has been used as an example of a traditional Chinese medication that is effective and may have a role in contemporary Western medicine. Because it is an unregulated supplement, different products are not standardized. Until regulation and standardization improve, its use will remain controversial.
David J. Becker, MD, is a cardiologist in private practice at Chestnut Hill Cardiology in Philadelphia. His research interests include the effects of lifestyle changes and supplements on the prevention of coronary artery disease.
Ram Y. Gordon, MD, is a cardiologist in private practice at Chestnut Hill Cardiology in Philadelphia. His research interests include the effects of lifestyle changes and supplements on the prevention of coronary artery disease.
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