As an alternative to prescription statin drugs used to lower cholesterol, the supplement red yeast rice has been used to try and achieve the same effect.
Red yeast rice is rice that has been fermented by the red yeast, Monascus purpureus, 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 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 a dietary supplement, involving the manufacturer, the U.S. Food and Drug Administration (FDA), and the pharmaceutical industry (particularly producers of HMG-CoA reductase inhibitor prescription drugs or “statins”).
Lovastatin also is believed to be the main cholesterol-lowering ingredient in Cholestin or HypoCol. The lovastatin in Mevacor is highly purified and concentrated, the lovastatin in HypoCol is not. Thus, they contain much lower concentrations of lovastatin than Mevacor. For example, each 600-mg capsule of Cholestin contains less than 2.4 mg of lovastatin (when this ingredient was contained in the product), whereas tablets of Mevacor contain 10 mg or more of this ingredient.
Small scale studies using pharmaceutical-grade red rice yeast have continued to demonstrate efficacy and safety. However, in the United States it is no longer legal to sell supplements of red yeast rice that contain more than trace amounts of cholesterol lowering substances. For example, the active ingredients of red rice yeast have been removed from Cholestin marketed in the United States.
The reasons the Food and Drug Administration (FDA) has ruled that it is illegal to sell red yeast rice that contains more than trace amounts of the cholesterol-lowering substances and to promote red yeast rice for lowering cholesterol levels.
- First, statin drugs are associated with muscle and kidney injury when used alone or combined with other medications. There is concern that patients who already take statin drugs with or without these other medications may increase their risk of muscle or kidney injury.
- Second, the FDA considers the products containing red yeast rice with high levels of cholesterol lowering substances to be new, unapproved drugs for which marketing violates the Federal Food, Drug, and Cosmetic Act.
Red yeast rice is proposed to be a mild aid for gastric problems (indigestion, diarrhea), blood circulation, and spleen and stomach health. Red yeast rice in a dried, powdered form is called Zhi Tai. When extracted with alcohol it is called Xue Zhi Kang.
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.
These studies consistently showed that Zhitai and Xuezhikang:
- lower total cholesterol (by an average of 10% to 30%),
- lower LDL cholesterol (by an average of 10% to 20%),
- lower triglycerides (by an average of 15% to 25%), and
- increase HDL (by an average of 7% to 15%).
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.
Dosing in Adults (18 years and older)
- 1,200 milligrams of concentrated red yeast powder capsules have been taken two times per day by mouth with food.
- The average consumption of naturally occurring red yeast rice in Asia has been reported as 14-55 grams per day.
Side Effects and Warnings
There is limited evidence on 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 or damage, dizziness, asthma, 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. A metabolite of Monascus called mycotoxin citrinin may be harmful.
Information obtained from the Mayo Clinic.
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