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Red Yeast Rice Revisited

Friday, October 29, 2010 // Uncategorized

10/20/2009 9:58:07 PM

There is a lot of interest in red yeast rice by those who are intolerant of cholesterol lowering medicines called statins.  This is a recent summary from The Medical Letter which is a nonprofit organization which publishes unbiased analyses of pharmaceuticals.

The Medical Letter®

On Drugs and Therapeutics

Published by The Medical Letter, Inc. • 1000 Main Street, New Rochelle, NY 10801 • A Nonprofit Publication

Volume 51  (Issue 1320)

September 7, 2009

Red Yeast Rice

Red yeast rice is a food product that has been used in Chinese cooking and medicine for centuries.  It is available in the US in a capsule formulation and is often used by patients who want a “natural” product to lower cholesterol.

THE PRODUCT — Red yeast rice is formed when rice is fermented with the yeast Monascus purpureus. The fermented product usually contains numerous monacolins, which are naturally occurring HMG-CoA reductase inhibitors. One of these, monacolin K, also known as mevinolin, became lovastatin (Mevacor, and others), the first statin approved in the US.

In one report analyzing the contents of 9 red yeast rice products on the market in the US, the total monacolin content varied by weight from 0% to 0.58% (REF 1). In another, among 10 such products, monacolin K content varied 100-fold (REF 2).

CLINICAL STUDIES —  In one study, the lipid-lowering effect of a red yeast rice product containing about 5 mg of monacolin K, 8 other monacolins, and other ingredients was equivalent to that of 20-40 mg of lovastatin (REF 3). A 24-week randomized double-blind study in 62 previously statin-intolerant patients found that LDL cholesterol decreased 21.3% (from 163.3 to 128.3 mg/dL) with 1800 mg of red yeast rice (about 13 mg of monacolin K) twice daily and 8.7% (from 165.1 to 149.8 mg/dL) with placebo (REF 4).

A double-blind, multicenter trial in China randomized 4870 patients with a previous myocardial infarction (MI) and total cholesterol >170 mg/dL to twice-daily treatment with 600 mg of a red yeast rice preparation (each 300-mg capsule contained 2.5-3.2 mg monacolin K) or placebo. After a mean of 4.5 years, the incidence of major coronary events, including nonfatal MI and death from coronary heart disease, was 5.7% with the supplement compared to 10.4% with placebo, a statistically significant difference (REF 5).

ADVERSE EFFECTS — As with lovastatin and other statins, myopathy can occur with red yeast rice (REF 6-8). Rhabdomyolysis was reported in a patient taking red yeast rice concurrently with cyclosporine, which is a moderate inhibitor of CYP3A4 (lovastatin is a substrate of CYP3A4) (REF 9). Hepatitis has been reported with red yeast rice (REF 10-11). Some of these products contain citrinin, a mycotoxin that can cause kidney failure in animals (REF 12). Statins are teratogenic in animals and should not be taken during pregnancy.

DIETARY SUPPLEMENTS — As with other dietary supplements, red yeast rice products do not require FDA approval and may contain unlabeled ingredients. Most labels for these products contain no information on their active ingredients. The FDA has tried, apparently unsuccessfully, to remove red yeast rice products from the US market as unapproved formulations of an approved drug (lovastatin).

DOSAGE AND COST — Most red yeast rice supplements are marketed as 600-mg capsules. The dosage suggested on their labels is two 600-mg capsules twice daily. The cost of one month’s treatment at the maximum dose is $16-$37 (REF 13). A month’s supply of generic lovastatin costs $4 at some discount pharmacies.

CONCLUSION — Red yeast rice products, which may contain one or more compounds that lower cholesterol by inhibiting HMG-CoA reductase, have been effective in lowering LDL-C in some studies, but the ingredients in these products are not standardized. Some contain mevinolin, which is lova-statin. Some contain citrinin, a mycotoxin that may cause renal failure. Generic lovastatin would be safer and could cost less.

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