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Red Yeast Rice (rice fermented with Monascus purpureus) is no stranger to the dietary supplements marketplace. For quite some time, it has been viewed as a better “natural alternative” to statin drugs by many individuals who visit health food stores as well as numerous health care practitioners. Recently a large university study of statin-intolerant individuals has provided evidence in support of this position. However, is Red Yeast Rice merely an alternative to statins for some individuals or is it something more?

Most people are aware of Red Yeast Rice due to the statin drug connection, so this is a good place to start. Statins technically are designated as 3-hydroxy-3-methylglutaryl coenzyme A [HMGCoA] reductase inhibitors. This means statins interfere with a cellular pathway the body uses to synthesize fats, including the fats that circulate in the bloodstream. As this suggests, the primary pharmaceutical use of statins is to lower serum cholesterol levels. Leaving aside any discussion of the efficacy of this approach to improving cardiovascular health, a number of side effects accompany this medical employment. These include gastrointestinal distress, elevated liver enzymes and muscle pain and weakness (stain-associated myalgias or SAMs). An arguably conservative estimate of SAMs incidence is on the order of 10 percent of all users. Quite serious, albeit rare, complications include rhabdomyolysis, which is a breakdown of muscle tissue. A number of statin side effects can be linked to significantly reduced endogenous production of ubiquinone (CoQ-10) with statin therapy.

The actual rate of side effects of statin therapy in clinical practice may be quite high. Even when statins are being prescribed medically for already diagnosed acute coronary syndrome, only 40 percent of patients remain on the program after two years. When statins are prescribed for prevention of the development of risks, the adherence rate drops to a mere 25 percent at the two-year mark. In other words, the true rate of side effects with prescribed statins is high in the general public, as opposed to the carefully monitored trials in which those who react poorly to statins in initial screenings generally are removed from the subject pool.

Red Yeast Rice and Statin Therapy
It is precisely this very large group of individuals who do not respond well to statin therapy that may have the most to gain from Red Yeast Rice. Red Yeast Rice recently was tested at the University of Pennsylvania School of Medicine in statin-intolerant patients. The goal specifically was to uncover whether in patients with a history of stain-associated myalgias, Red Yeast Rice in addition to a change in living habits would have a significant impact on hypercholesterolemia. As described in the study, patients were assigned to receive Red Yeast Rice (1800 mg delivering) or placebo twice daily for 24 weeks. All patients also were enrolled in a 12-week therapeutic lifestyle change program.

The results of the trial indicate the promise of Red Yeast Rice taken at a level supplying daily only six mg of monacolin K (lovastatin) and 13 mg total monacolins (at least nine have been identified). Low density cholesterol (LDL) at 12 weeks had dropped 43 mg/dL in the Red Yeast Rice group versus 11 mg/dL in the placebo group (both groups having adopted changes in diet and exercise). At 24 weeks, LDL still remained 35 mg/dL below baseline versus 15 mg/dL in the placebo group. At both time points, the differences were statistically significant. The small drop-off in effect in the Red Yeast Rice group was viewed by the researchers as reflecting a small decline in adherence to the protocol after the first 12 weeks. Very importantly, levels of HDL cholesterol, triglyceride, liver enzymes, weight loss and pain did not differ between the active and placebo groups at either 12 or 24 weeks. There were no indications of muscle damage, i.e., myositis (elevated creatinine phosphokinase/CPK level). The conclusion of the study: “Red Yeast Rice and therapeutic lifestyle change decrease LDL cholesterol level without increasing CPK or pain levels and may be a treatment option for dyslipidemic patients who cannot tolerate statin therapy.”

Red Yeast Rice Recognized for Its Healing Benefitfor Over 1000 Years
A normal low dose of lovastatin is 10 mg/day, therefore the benefits from the Red Yeast Rice supplement tested in the Pennsylvania study appeared with a monacolin K intake that was approximately one half the level expected to be needed to exhibit benefits. This finding leads to a number of questions that should interest individuals considering supplementing with Red Yeast Rice. For instance, is Red Yeast Rice merely a natural source of statin-related compounds? Does Red Yeast Rice yield benefits primarily by lowering cholesterol levels? Red Yeast Rice’s place in Chinese medicine stretches back more than a millennium. If Red Yeast Rice, including forms that supply very limited amounts of monacolins, especially monacolin K (lovastatin), has always provided benefits in traditional Chinese medicine, what are the implications? Is it serum cholesterol that is important in this picture or is it something else? And what about precautions and side effects?

It needs to be clear that the employment of Red Yeast Rice in Chinese medicine goes back at least to the period of the Tang Dynasty, circa 800 A.D. It was taken internally to “invigorate the body, aid in digestion, and revitalize the blood.” To elaborate slightly, the classic description is that Red Yeast Rice invigorates blood circulation and eliminates blood stasis, a use that seems strikingly akin to our contemporary cardiovascular employment. Most modern commentators take this a step further by drawing on the fact that in the late 1970s it was discovered monacolin K can be isolated from Red Yeast Rice. In light of this discovery, it usually is concluded the presence of monacolin K provides the scientific support for the traditional use and health claims for Red Yeast Rice.

That conclusion is tempting, very tempting, but almost certainly to some extent either wrong or misleading. It is now very well established that traditionally-produced Red Yeast Rice contains only small amounts of monacolin K. Modern techniques and the selection of yeast strains have been developed that greatly increase the monacolin content of the rice. These techniques have become more commonplace even in the Red Yeast Rice now produced for food flavoring and coloring purposes. Quite simply, the Red Yeast Rice found in traditional Chinese medicine for more than a thousand years did not depend on large amounts of monacolin K to provide its benefits. Red Yeast Rice HDL Cholesterol Levels

Moreover, there are a number of striking divergences between the effects of statin drugs and those of Red Yeast Rice. The divergences arguably strongly favor the use of Red Yeast Rice over statin drugs under many circumstances. For one thing, several studies have shown increased diagnosis of diabetes and a lack of glycemic control in diabetes mellitus in patients taking high and/or long-term doses of statins. Just the opposite appears to be the case with Red Yeast Rice extracts. One recent Chinese study found that Red Yeast Rice extract decreased insulin and blood glucose levels in a group of Type II diabetics, meaning there was better blood sugar regulation. This certainly is a point in the favor of Red Yeast Rice.

The diabetes aspect shows up again in the evaluation of statin use and HDL cholesterol. Statins usually are not considered to exert any particular benefit for raising HDL levels; the effects found in the various trials, even when positive, have been small. A recent analysis of the data of a large number of trials shows clearly that the presence of diabetes reduces benefits in the area of HDL even further.

In the University of Pennsylvania study of Red Yeast Rice, there were improvements in HDL in both the active and the placebo groups, a fact that indicates the interventions in diet and other habits were in themselves sufficient to influence HDL levels. Whether Red Yeast Rice is of benefit to HDL was examined in a review of Chinese clinical trials. That review found that, compared with placebo, Red Yeast Rice interventions did, indeed, improve HDL levels. Chalk up another point in favor of Red Yeast Rice.

Red Yeast Rice and C-Reactive Protein
Red Yeast Rice may play a role in yet another area that is important to cardiovascular health, but has very little relation to serum lipids. C-reactive protein (CRP) typically is defined as a nonspecific inflammatory marker. It is widely used to monitor treatment of cardiovascular diseases inasmuch as high serum CRP levels indicate poor outcomes. Moreover, reducing CRP in individuals with completely normal blood lipids also reduces cardiovascular events. This has been shown convincingly with at least one statin. Indeed, given the fact more than half of all cardiovascular events occur in individuals with no lipids abnormalities, there are clear reasons for looking at non-lipid aspects of health. Red Yeast Rice may lower CRP levels rapidly (even within 24 hours) and effectively, including improving endothelial function. An increasing number of researchers are coming to the conclusion, it is the impact of statins on CRP, not lipids, that explains their cardiovascular benefits. Red Yeast Rice contains a number of components that strongly affect CRP and this goes a long ways towards explaining both traditional uses in Chinese medicine and the benefits that appear despite low levels on monacolin K.

Additional Benefits of Red Yeast Rice

One final area remains to be covered?—?alternative treatments. A combination of lifestyle changes plus fish oils added to Red Yeast Rice has been demonstrated to yield dramatic benefits over a period of 12 weeks, including in comparison with a statin group receiving medication and traditional counseling. The alternative treatment reduced LDL by 42.4 percent and the statin reduced LDL by 39.6 percent. The points of separation between the treatments lay elsewhere. Whereas in the statin groups triglycerides were reduced only 9.3 percent and weight only by 0.4 percent, in the alternative treatment group both were reduced nicely! Triglycerides went down 29 percent and weight dropped by 5.5 percent.

In short, Red Yeast Rice may present a reasonable alternative to standard medical treatments for cardiovascular risk factors. This is especially the case if the Red Yeast Rice is combined with changes in exercise and eating habits plus alternative therapies, such as omega-3 fatty acids from fish oils. Nevertheless, a few caveats apply. For one, Red Yeast Rice does contain some monacolin K, hence if consumed at higher levels of intake and/or chronically, co-ingestion with coenzyme Q-10 (ubiquinone, CoQ-10) or ubiquinol (reduced CoQ-10) is highly advised. Likewise, in excess, Red Yeast Rice consumed chronically may be expected to produce some of the side effects found with statin drugs. Another point to consider is that the anti-inflammatory effect of Red Yeast Rice can exhibit a short-term rebound after long-term chronic use if supplementation is stopped suddenly. Therefore, tapering off is a wise idea. With these points in mind, Red Yeast Rice remains a reasonable alternative for those who want to protect the?

References available upon request.

Dallas Clouatre, PhD

Dallas Clouatre, Ph.D. earned his A.B. from Stanford and his Ph.D. from the University of California at Berkeley. A Fellow of the American College of Nutrition, he is a prominent industry consultant in the US, Europe, and Asia, and is a sought-after speaker and spokesperson. He is the author of numerous books. Recent publications include "Tocotrienols in Vitamin E: Hype or Science?" and "Vitamin E – Natural vs. Synthetic" in Tocotrienols: Vitamin E Beyond Tocopherols (2008), "Grape Seed Extract" in the Encyclopedia Of Dietary Supplements (2005), "Kava Kava: Examining New Reports of Toxicity" in Toxicology Letters (2004) and Anti-Fat Nutrients (4th edition).