Fermented rice
This section is a list of chemical entities identified in this dietary supplement to possess pharmacological activity. This list does not imply that other, yet unidentified, constituents do not influence the pharmacological activity of this dietary supplement nor does it imply that any one constituent possesses greater influence on the overall pharmacological effect of this dietary supplement.
Mevinolin and related monocolins (HMG-CoA reductase inhibitors).
Monascus purpureus is a destructive mold that grows on starch and silage. Red yeast rice is traditionally prepared by fermenting boiled non-glutinous rice with red wine mash, natural juice of Polygonum grass, and alum water. In practice, the fungus is cultivated on rice and then ground into a powder. Red yeast rice has been used for centuries in the making of rice wine, as a food preservative, and for its medicinal properties. It is used today in traditional Chinese medicine and as a food coloring. Until recently, the nutritional and medicinal properties of red yeast rice were not fully appreciated by the Western world. Recent biochemical and pharmacological studies have identified red yeast rice as a beneficial supplement for maintaining a healthy balance of cholesterol and related lipids in the body. Studies have reported lowering of LDL and triglycerides while increasing HDL.
Interactions and Depletions
600-1,200mg, 2 times a day. The dose should not exceed 4,800mg (4.8 grams) in a 24-hour period.
Two 600mg capsules, 2 times a day, taken in the morning and the evening with food. The dose should not exceed 4,800mg (4.8 grams) in a 24-hour period.
*Standardization represents the complete body of information and controls that serve to enhance the batch to batch consistency of a botanical product, including but not limited to the presence of a marker compound at a defined level or within a defined range.
The most current available medical and scientific literature indicates that this dietary supplement should be standardized to 0.4% total HMG-CoA reductase inhibitors per dose.
Frequently Reported Uses- Lowering LDL-Cholesterol
- Raising HDL-Cholesterol
- Reducing Serum Cholesterol
- Reducing Serum Triglycerides
Other Reported Uses
Reported safe in recommended doses.
As with all HMG-CoA reductase inhibitors, long term users of red yeast rice should consider periodic monitoring of liver function.(1)
Red yeast rice is contraindicated in individuals who are hypersensitive or allergic to rice or yeast.
Red yeast rice is contraindicated in individuals at risk for liver disease, active liver disease, or a history of liver disease; serious infections; a history of organ transplantation; or recent major surgery.
Only a few mild side effects have been associated with red yeast rice. These include heartburn, abdominal flatulence, and dizziness.(
2)
This product may exacerbate pre-existing gastritis. The frequency of these effects is extremely low (less than 2%).(3)
Discontinue use of red yeast rice if experiencing unexplained muscle pain, tenderness or weakness, especially if accompanied by flu-like symptoms.
If pregnant or nursing, consult a physician before use.
Do not use in individuals under 20 years of age unless directed by a physician.
In 1976, Japanese researchers reported the discovery of mevastatin, a fungal metabolite isolated from the cultures of
Penicillium citrinum and
P. brevicompactin.(
4) Mevastatin was found to be a potent inhibitor of the enzyme 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA reductase), the enzyme that is the rate-limiting step in the synthesis of cholesterol. These agents play a prominent role in the management of hypercholesterolemia, a significant risk factor for coronary artery disease.(
5) Eight HMG-CoA reductase inhibitors have been identified, including lovastatin and its active hydroxy-acid metabolite.
In recent years, at least 34 separate clinical studies (17 controlled and 17 open-label) in China and the United States have assessed the efficacy of M. purpureus red yeast rice as a cholesterol-lowering agent. One major randomized, single-blind, multicenter clinical trial involved 446 hyperlipidemic subjects.(6) After eight weeks, blood levels of total cholesterol, low-density lipoprotein cholesterol and triglycerides in the red yeast rice treatment group were reduced by 22.7, 30.9 and 34.1 percent, respectively. In addition, HDL-c levels increased by 19.9 percent in the red yeast rice treatment group. This increase was significantly greater than the 8.4 percent increase observed in the control group.
In a major prospective double-blind, randomized clinical trial involving 152 subjects,(7) total cholesterol was reduced by 19 percent compared to 1.5 percent in the placebo group. Triglycerides were reduced by 36 percent compared to 10 percent in the placebo group. In another double-blind, placebo-controlled randomized clinical study, researchers evaluated the efficacy and safety of a proprietary red yeast rice product. After eight weeks, total cholesterol levels of the treatment group decreased by 18 percent while those in the placebo group remained unchanged.(8) No serious adverse effects were observed in the study.(9) Results from another randomized, controlled trial found that after 24 weeks 30% of patients taking red yeast rice achieved an LDL cholesterol level of 100 mg/dL or lower, compared to only 6.9% of those taking a placebo and there also were not any serious adverse events.(10)
Recently released findings of a U.S. multi-center, open-label trial confirmed the consistent cholesterol-lowering effects of red yeast rice.(11) In a 2-month study involving 187 subjects, a twice-daily regimen of a proprietary red yeast rice product was found to reduce total cholesterol and LDL-c levels by 16 and 22 percent, respectively. Moreover, when the treatment was discontinued, these levels returned to pretreatment values within two weeks. Red yeast rice was compared with pravastatin in a randomized, single-blind, controlled study.(12) Forty-four subjects diagnosed with essential hyperlipidemia were randomly divided into two equal groups. After four weeks, both treatments caused significant and comparable reductions in total serum cholesterol and LDL-c.
Several studies found that red yeast rice significantly reduced inflammation and lowered lipid levels suggesting this supplement to be effective in treating high cholesterol.(13),(14),(15),(16),(17),(18),(19)
Red yeast rice reduced cardiovascular events and significantly decreased risk of cardiovascular death. Also, of great importance, there were no side effects reported in any of the studies.(20),(21),(22)
Laboratoy studies using red yeast rice on several different types of cancer cells found that red yeast rice inhibited the growth of the cancer cells. In vivo studies are needed to further establish the potential advantages of red yeast rice in cancer chemoprevention.(23),(24)
In addition to naturally occurring HMG-CoA reductase inhibitors, red yeast rice contains several other bioactive compounds, including unsaturated fatty acids, amino acids,(25) phytosterols, isoflavone, saponins, and trace elements such as selenium.
The clinical evidence strongly suggests that red yeast rice is an effective natural dietary supplement for controlling serum cholesterol, and that the product is well-tolerated in humans. Because of a theoretical depletion of CoQ10 by red rice yeast HMG-CoA reductase inhibiting activity, additional supplementation of CoQ10 should be considered.