Red yeast rice (Monascus purpureus)

Red yeast rice (Monascus purpureus)

Background

Red yeast rice (RYR) is the product of yeast ( Monascus purpureus ) grown on rice, and is served as a dietary staple in some Asian countries. It contains several compounds collectively known as Monacolins, substances known to inhibit cholesterol synthesis. One of these, "Monacolin K" is a potent inhibitor of HMG-CoA reductase, and is also known as Mevinolin or Lovastatin (Mevacor®, a drug produced by Merck & Co., Inc).

Red yeast rice extract (RYRE) has been sold as a natural cholesterol-lowering agent in over the counter supplements, such as Cholestin ^TM (Pharmanex, Inc). However, there has been legal and industrial dispute as to whether red yeast rice is a drug or dietary supplement, involving this manufacturer, the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry (particularly producers of HMG-CoA reductase inhibitor prescription drugs or "statins").

The use of RYR in China was first documented in the Tang Dynasty in 800 A.D. A detailed description of its manufacture is found in the ancient Chinese pharmacopoeia, Ben Cao Gang Mu-Dan Shi Bu Yi, published during the Ming Dynasty (1368-1644). In this text, RYR is proposed to be a mild aid for gastric problems (indigestion, diarrhea), blood circulation and spleen and stomach health. RYR in a dried, powdered form is called ZhiTai. When extracted with alcohol it is called XueZhiKang.

According to the Pharmanex website (accessed in September 2003), new and improved Cholestin ^TM contains policosanol, a natural product from the wax of honey bees called Apis mellifera . It no longer contains any red yeast. Policosanols are potent inhibitors of cholesterol synthesis and have been well-studied in clinical trials in Cuba and South America.

Synonyms

Angkak, Beni-koju, Hong Qu, Hung-chu, Monascus, Red Koji, Red Leaven, Red Rice, Red Rice Yeast, Red Yeast Rice, Went, XueZhiKang, ZhiTai.

Evidence

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

Uses based on scientific evidenceGrade*High cholesterol
Since the 1970s, human studies have reported that red yeast lowers blood levels of total cholesterol, low-density lipoprotein/LDL ("bad cholesterol"), and triglyceride levels. In March 2001, a U.S. District Court ruled that the red yeast rice extract product Cholestin ^TM contains the same chemical as the prescription cholesterol-lowering drug lovastatin (Mevacor®) and therefore cannot be sold without a prescription. Lovastatin, like other "statin" drugs, has been shown in multiple well-designed controlled trials to reduce total cholesterol and LDL levels. Cholestin ^TM has since been reformulated to contain different ingredients (such as policosanol). Other products containing red yeast rice extract can still be purchased, mostly over the Internet. However, these products may not be standardized, and effects are not predictable. For lowering cholesterol, there is better evidence for using prescription drugs such as lovastatin.

A

* Key to grades
A: Strong scientific evidence for this use;
B: Good scientific evidence for this use;
C: Unclear scientific evidence for this use;
D: Fair scientific evidence against this use (it may not work);
F: Strong scientific evidence against this use (it likely does not work).

Uses based on tradition or theory
The below uses are based on tradition or scientific theories. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

Anthrax, blood circulation problems, bruised muscles, bruises, colic in children, diarrhea, dysentery (bloody diarrhea), hangover, high blood pressure, indigestion, postpartum problems, spleen problems, stomach problems, wounds.

Dosing

The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.

Adults (18 years and older):

Capsules: 1,200 milligrams of concentrated red yeast powder two times per day by mouth with food has been used.

Children (younger than 18 years):

There is not enough scientific evidence to recommend red yeast for children.

Safety

The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

There is one report of anaphylaxis (a severe allergic reaction) in a butcher who touched meat containing red yeast.

Side Effects and Warnings

There is limited evidence about the side effects of red yeast. Mild headache and abdominal discomfort can occur. Side effects may be similar to those for the prescription drug lovastatin (Mevacor®). Heartburn, gas, bloating, muscle pain, dizziness, and kidney problems are possible. People with liver disease should not use red yeast products.

In theory, red yeast may increase the risk of bleeding. Caution is advised in patients with bleeding disorders or taking drugs that may increase the risk of bleeding. Dosing adjustments may be necessary.

Pregnancy and Breastfeeding

Prescription drugs with similar chemicals as red yeast cannot be used during pregnancy. Therefore, it is strongly recommended that pregnant or breast-feeding women not take red yeast.

References

1. Bonovich K, Colfer H, Petoskey MI, et al. A multi-center, self-controlled study of Cholestin in subjects with elevated cholesterol. J Invest Med 1999;47(2):54A.

2. Gavagan T. Cardiovascular disease. Prim Care. 2002 Jun;29(2):323-38, vi.

3. Heber D, Yip I, Ashley JM, et al. Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement. Am J Clin Nutr 1999;69(2):231-236.

4. Heber D. Dietary supplement or drug? The case for cholestin [letter]. Am J Clin Nutr 1999;70(1):106-108.

5. Hsieh PS, Tai YH. Aqueous extract of Monascus purpureus M9011 prevents and reverses fructose-induced hypertension in rats. J Agric Food Chem. 2003 Jul 2;51 (14) :3945-50.

6. Liu L, Zhao SP, Cheng YC, Li YL. Xuezhikang decreases serum lipoprotein(a) and C-reactive protein concentrations in patients with coronary heart disease. Clin Chem. 2003 Aug;49(8):1347-52.

7. Su YC, Wang JJ, Lin TT, Pan TM. Production of the secondary metabolites gamma-aminobutyric acid and monacolin K by Monascus. J Ind Microbiol Biotechnol. 2003 Jan;30(1):41-6. Epub 2003 Jan 03.

8. Thompson Coon JS, Ernst E. Herbs for serum cholesterol reduction: a systematic view. J Fam Pract. 2003 Jun;52(6):468-78.

9. Wang J, Lu Z, Chi J, et al. Multicenter clinical trial of the serum lipid-lowering effects of a (red yeast) rice preparation from traditional Chinese medicine. Curr Ther Res 1997;58(12):964-978. Wei W, Li C, Wang Y, Su H, Zhu J, Kritchevsky D. Hypolipidemic and anti-atherogenic effects of long-term Cholestin (Monascus purpureus-fermented rice, red yeast rice) in cholesterol fed rabbits. J Nutr Biochem. 2003 Jun;14(6):314-8.

10. Wei J, Yang H, Zhang C, et al. A comparative study of xuezhikang and mevalotin in treatment of essential hyperlipidemia. Chin J New Drugs 1997;6:265-268.

January 01, 2004