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Abstract

Dyslipidemia is a growing concern causing significant morbidity and mortality. High cholesterol levels increase the risk of individuals developing heart disease, stroke, and other disease states. Dietary modification is the initial approach for treatment, but many patients require statins (3-hydroxy-3-methylglutaryl co-enzyme A reductase inhibitors) to reduce cardiovascular risk. Unfortunately, a number of patients cannot tolerate statins, leading to practitioners searching for alternative regimens. One alternative that has been extensively studied is red yeast rice (Monascus purpureus), a dietary supplement. In patients with dyslipidemia, red yeast rice was efficacious and safe for short-term use (<16 weeks). Red yeast rice has also been studied head to head with statins and was shown to be noninferior in reducing cholesterol levels and cardiovascular risk. Because of the positive clinical effects seen in dyslipidemia, researchers have begun to study its use in other disease states.

Keywords

red yeast rice statins dyslipidemia cholesterol polyketides monacolins

Red yeast rice, also known as Red Koji, Hong Qu, Ang-kak, red mold rice, and Beni-Koji, is a traditional Chinese food product used as a flavoring, colorant, and preservative in cooking and medicinally for its blood circulation and food digestion promoting properties. The development of red yeast rice is believed to date back more than a thousand years; its use has been documented during the Chinese Tang dynasty (around 800 ad) and continues to be a dietary staple in numerous Asian countries today. Red yeast rice is the fermented product of rice inoculated with red yeast, Monascus purpureus.^1,2 The traditional method of making red yeast rice is based on a fermentation process whereby the yeast is allowed to ferment naturally on a bed of cooked nonglutinous whole rice kernel. When red yeast rice is prepared by this traditional method of solid-state fermentation under controlled conditions, it produces a family of polyketides called monacolins that can inhibit cholesterol production.^3,4 Red yeast rice contains several monacolins, all of which have the ability to inhibit the enzyme 3-hydroxy-3-methylglutaryl co-enzyme A (CoA) reductase, which is an essential step in cholesterol biosynthesis. Specifically, monacolin K, also known as mevicolin or lovastatin, is the monacolin in red yeast rice that has the same chemical structure as the purified, aspergillus-derived monacolin K known as the pharmaceutical drug Mevacor (Merck & Co, Inc).⁵ Closely related to monacolin K is the hydroxy acid form called monacolin KA, which is the activated form of lovastatin after it passes through the liver. Monacolin K (lovastatin) and monacolin KA (hydroxyl acid form of lovastatin) are typically the predominant active ingredients in most commercially available red yeast rice preparations (Table 1 ).⁶ Other active ingredients in red yeast rice include plant sterols (β-sitosterol, campesterol, stigmasterol, and sapogenin), isoflavones and isoflavone glycosides, zinc, selenium, and monounsaturated fatty acids.⁷

Table 1.

Analysis of Commercially Available Red Yeast Rice Preparations6

Product (Manufacturer)	RYR Dosage/Administration	Total Daily Dosage (Lovastatin/capsule)
Choleast (Thorne Research, Inc)	600 mg/capsule; no frequency suggested	None suggested (1.7 mg/capsule)
Cholestene (HPF, Inc)	600 mg/capsule^a; 2 capsules twice daily	2.4 g/d (3.4 mg/capsule)
Chole-sterin (Atrium, Inc)	600 mg/capsule; 2 capsules twice daily	2.4 g/d (2.3 mg/capsule)
Doctors Best RYR (Doctors Best, Inc)	1200 mg/capsule; 1 capsule daily	1.2 g/d (3 mg/capsule)
Healthy America RYR (Healthy America)	600 mg/capsule; 2 capsules once or twice daily	1.2-2.4 g/d (0.6 mg/capsule)
Nature’s Sunshine RYR (Nature’s Sunshine Products, Inc)	570 mg/capsule; 2 capsules 2 or 3 times daily	2.28-3.42 g/d (1.3 mg/capsule)
NSI RYR (Nutraceutical Life Sciences)	600 mg/capsule; 1 capsule daily	0.6 g/d (3.5 mg/capsule)
Solaray RYR (Nutraceutical Corp)	600 mg/capsule; 1 capsule daily	0.6 g/d (0.8 mg/capsule)
Spring Valley RYR (US Nutrition, Inc)	600 mg/capsule; 2 capsules once or twice daily	1.2-2.4 g/d (0.9 mg/capsule)
Stop Aging Now Extra Strength RYR (Stop Aging Now, LLC)	600 mg/capsule; 2 capsules daily	1.2 g/d (0.3 mg/capsule)
Swanson Traditional RYR (Swanson Health Products)	600 mg/capsule; 1 capsule twice daily	1.2 g/d (0 mg/capsule)

Abbreviations: RYR, red yeast rice.

^a Claimed to contain 600 mg of red yeassst rice; however, when tested only contained 443 mg/capsule.

Pharmacology

Clinical observations have shown that red yeast rice has the ability to lower total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides in both animal models and humans.^3–5 This is largely a result of enzymatic inhibition of the conversion of 3-hydroxy-3-methylglutaryl CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis (Figure 1 ). Although it is known that monacolin K is effective at lowering cholesterol because of this enzymatic inhibition, one study in humans found that it is unlikely to be solely the result of a single species of monacolin but rather the result of a synergy of the action of monacolins and other substances in red yeast rice.³ Other mechanisms could involve diminished absorption of cholesterol, presumably as a result of competition between sterols in red yeast rice and cholesterol for incorporation into micelles or for transport across the intestinal cell membrane.^7–9

Figure 1.

Red yeast rice effects on cholesterol biosynthesis

Clinical Efficacy of Red Yeast Rice for Dyslipidemia

Multiple clinical trials have been conducted to determine the efficacy of red yeast rice and red yeast rice extracts for dyslipidemia. In the United States, a clinical trial was conducted that included 83 healthy adults with dyslipidemia. Patients were randomized to receive either red yeast rice supplementation (2.4 g/d) or placebo for a total of 12 weeks. Supplementation with red yeast rice significantly reduced total cholesterol (P < .001), triglycerides (P < .05), and LDL cholesterol (P < .001) in comparison with placebo. High-density lipoprotein (HDL) did not significantly differ from baseline in either group.⁹ Another study, performed in China, included 79 patients with a mean baseline LDL cholesterol of 203.9 mg/dL. Patients were randomized to receive either red yeast rice 600 mg twice daily or placebo for a total of 8 weeks. Compared with baseline, LDL cholesterol was reduced by 27.7% (P < .001), total cholesterol by 21.5% (P < .001), triglycerides by 15.8% (P < .05), and apolipoprotein B by 26% (P < .001) in the red yeast rice supplementation group. An increase of HDL in the red yeast rice group of 0.9% from baseline did occur; however, this result was not significant.¹⁰ A specific red yeast rice product, HypoCol, was evaluated for its effects on plasma lipids, fasting plasma glucose, glycosylated hemoglobin, and C-reactive protein for 16 weeks. Patients were randomized to receive either 4 capsules of HypoCol or placebo. Patients in the study group had a significant reduction in LDL cholesterol by 23% and total cholesterol by 15.5% compared with the placebo group (P < .001). However, no significant results were observed in glucose and inflammatory parameters.¹¹ Liu et al⁴ conducted a meta-analysis of 93 randomized trials (9625 participants) that compared red yeast rice with placebo, statins, and other lipid-lowering therapies in patients with dyslipidemia. There were 3 different preparations of red yeast rice (Cholestin, Xueshikang, and Zhibituo) in the trials analyzed. All preparations showed significant reductions in total cholesterol, triglycerides, and LDL cholesterol compared with placebo (P < .00001). Only the participants receiving the Zhibituo preparation showed a significant improvement of HDL levels (P < .00001).⁴

Based on positive results in using red yeast rice compared with placebo in patients with dyslipidemia, trials have been conducted to evaluate the lipid-lowering effects of red yeast rice compared with statins. Becker et al¹² evaluated simvastatin at a dose of 40 mg daily versus red yeast rice, fish oil, and lifestyle changes for a period of 12 weeks. Significant reduction in LDL cholesterol from baseline was found in both groups (P < .001), but no significant differences were found between the 2 groups. However, the group receiving red yeast rice, fish oil, and lifestyle changes had significant reduction in triglycerides (P = .003) in comparison to the simvastatin group.¹² Another study by the same group of researchers was conducted comparing red yeast rice at a dose of 2400 mg twice daily with pravastatin 20 mg twice daily for 12 weeks. The purpose of the study was to determine the tolerability of red yeast rice in patients considered intolerant to statin therapy (defined as having a prior history of myalgias while receiving a statin). Tolerability was similar in both groups with <10% of patients experiencing myalgias. A reduction in LDL cholesterol was found to be similar in both groups: 30% in the red yeast rice group and 27% in the pravastatin group from baseline.¹³ A trial evaluating the safety and efficacy of red yeast rice in patients with dyslipidemia was conducted. A total of 62 patients with a prior history of statin-associated myalgias were randomized to receive either red yeast rice 1800 mg twice daily or placebo twice daily for 24 weeks. The LDL cholesterol decreased by 23%, and total cholesterol decreased by 16% in the red yeast rice group compared with baseline at the end of 24 weeks. In the red yeast rice group, the LDL cholesterol levels at week 12 and week 24 were significantly lower than that in the placebo group: P < .001 and P = .011, respectively. There was no difference in liver transaminase and creatine phosphokinase levels, and presence of myalgias in either group compared with baseline levels.¹⁴ A recent trial retrospectively evaluated the use of red yeast rice for dyslipidemia in 25 patients with a history of statin-associated myalgias, elevated transaminases, and/or gastrointestinal intolerance. Patients were included if they received 1200 mg of red yeast rice at bedtime for at least 4 weeks. The total cholesterol decreased by 13% and the LDL cholesterol by 19% from baseline. The majority of patients (92%) tolerated red yeast rice and achieved their LDL cholesterol goal (56%).¹⁵

Multiple studies evaluating a specific red yeast rice extract, Xuezhikang, on dyslipidemia and coronary events have been conducted in China. Liu et al¹⁶ randomized 50 patients with coronary heart disease to receive the study medication Xuezhikang at a dose of 1200 mg daily or placebo for 6 weeks. After 6 weeks, the Xuezhikang group had significantly decreased C-reactive protein concentrations (P < .05), serum lipoprotein A (P < .05), and triglyceride levels (P < .001) compared with baseline levels. A large clinical study was conducted in patients with previous myocardial infarction. Approximately 5000 patients were enrolled and monitored for 4.5 years. Patients were randomized to receive either Xuezhikang 300 mg or placebo. Patients treated with Xuezhikang had a significant 20% reduction in LDL cholesterol (P < .01) and a significant decrease in frequency of major coronary events (P < .001) from baseline.¹⁷ A subgroup analysis of this study was conducted to evaluate the lipid-lowering effects of Xuezhikang in elderly patients (>65 years of age) with coronary heart disease, over a 4-year period. The patients receiving Xuezhikang had a 37% reduction in coronary events (P = .001), 44% reduction in stroke (P = .04), 31% decrease in cardiac-related mortality (P = .04), and 32% decrease in all-cause mortality (P = .01) compared with the placebo group.¹⁸ The study researchers also conducted another subgroup analysis in patients with type 2 diabetes. A total of 591 diabetic patients with cardiovascular disease were randomized to either receive Xuezhikang or placebo and followed for 4 years. In the Xuezhikang group, the risk reduction for cardiovascular heart disease events was 51% (P < .001), decreasing nonfatal myocardial infarction by 64%, fatal myocardial infarction by 59%, and cardiovascular sudden death by 27% from baseline.¹⁹ More recent studies have shown that the Xuezhikang extract is beneficial in improving left-ventricular diastolic function in patients with hypertension as well as efficacious in lowering morbidity and mortality in elderly patients with a history of myocardial infarction, independent of its lipid-lowering effects.^20,21

Safety of Red Yeast Rice for Dyslipidemia

Because of the presence of lovastatin (monacolin K and monacolin KA) in red yeast rice, the US Food and Drug Administration (FDA) ruled that red yeast rice was not a dietary supplement but rather a drug. They asked companies producing red yeast rice to reformulate their products to no longer contain lovastatin.² Despite these rulings from the FDA, red yeast rice continues to be produced in the United States with trace amounts of lovastatin, and multiple formulations and strengths exist (Table 1).⁶ One study evaluated 9 red yeast rice preparations and found great variation in the amount and type of monacolins among the products.³ Therefore, determining clinical response and effectiveness with these products becomes extremely difficult.

Multiple clinical studies have indicated that red yeast rice is a safe option for patients, with limited side effects; however, case reports have implicated red yeast rice in causing acute hepatitis, myopathy, and rhabdomyolysis.^22–24 Development of myopathy or myalgias is believed to be a result of monacolins also blocking the production of coenzyme Q₁₀ leading to deficiency and the development of atrophic muscular changes.²⁵ Another concern is the potential for the toxin citrinin to be included in the final red yeast rice product. Citrinin, a by-product of the red yeast rice fermentation process, has been found in available preparations, and studies conducted in animals have found that it has nephrotoxic capabilities.⁶

Other Clinical Implications for Red Yeast Rice

Most commonly, red yeast rice is used to treat dyslipidemia, but recent research suggests other potential indications for its clinical applicability. Research is being conducted investigating the use of red yeast rice in diabetes mellitus, hypertension, obesity, depression, cancer, and osteoporosis. Red yeast rice has antioxidant and anti-inflammatory properties that could be useful in other disease states. Studies in this area involve mainly cellular and animal research; however, further investigation could translate these findings to human medicine.

Diabetes affects 8.3% of the US population and can lead to complications such as heart attack and stroke.²⁶ Type II diabetes mellitus patients exhibit insulin resistance leading to hyperglycemia. A study in rats found that orally administered red yeast rice can decrease plasma glucose, delay insulin resistance, and increase insulin sensitivity.²⁷ Red yeast rice increases the release of acetylcholine, resulting in increased insulin secretion in rats.²⁸ These studies suggest that red yeast rice could be useful in prediabetic patients, although further research is needed to confirm this benefit in humans.

Hypertension is another chronic disease state affecting a large percentage of the population. Red yeast rice is reported to produce antihypertensive effects by 3 mechanisms. The first mechanism is through γ-aminobutyric acid (GABA) content in Monascus purpureus M9011.²⁹ When red yeast rice was compared with pure GABA in rats with fructose-induced hypertension, the red yeast rice had a more potent antihypertensive effect.²⁹ The study indicated that other components besides the GABA content contributed to the antihypertensive effect of red yeast rice. The second mechanism is through acetylcholine chloride that was identified in Monascus pilosus IFO4520.³⁰ Finally, the third mechanism is through inhibition of angiotensin I–converting enzyme by 4 active peptides that were found in Monascus purpureus IFO 4489.³¹ Based on these results, red yeast rice could be helpful in reducing blood pressure in diabetic patients and in the general population; however, human studies are needed before it can be recommended for the treatment of hypertension.

Another potential use of red yeast rice is in obesity, and this was first observed in 3T3-L1 cells where red yeast rice extract was found to inhibit adipocyte differentiation and enhance lipolysis.^32,33 The effect was further tested in Wistar rats on a high-fat diet. The rats that were fed red yeast rice had less weight gain and decreased cholesterol and insulin levels.³³ The antiobesity effects of red yeast rice could be a result of its appetite suppression activity and increased lipolysis.³³ These effects of red yeast rice have not been tested in humans, although use as an appetite suppressant would be particularly useful.

Also, components of red yeast rice were found to have monoamine oxidase inhibitory activity.³⁴ Monankarins A to D had monoamine oxidase–inhibiting activity, with monankarin C showing strong monoamine oxidase-B inhibition in mice brain cells.³⁴ Monoamine oxidase inhibitors have therapeutic use in the treatment of depression.

Cellular and animal studies have used red yeast rice to promote bone growth.^35–37 In a cellular study, red yeast rice was found to increase the proliferation of osteoblasts, thus promoting the synthesis of collagenous proteins and factors essential for bone growth.³⁶ These bone-promoting qualities of red yeast rice were further tested on parietal bones of white rabbits. Red yeast rice was mixed with a collagen matrix and applied to the damaged bone. There was more bone formation in rabbits treated with the red yeast rice mixture than in those treated with just a collagen matrix alone.³⁵ Although bone formation is an exciting new area for potential red yeast rice use, research has not moved beyond animal studies, and more research is needed to determine if this effect translates into human medicine.

An epidemiological study revealed that patients taking statins had a reduced risk of developing colorectal cancer.³⁸ This potential benefit from statins has promoted investigation into the ability of red yeast rice to alter cancer risk. A study investigated which components of red yeast rice helped decrease the growth of colon cancer cells.³⁹ Lovastatin and monacolin-rich red yeast rice had similar abilities to stop colon cancer cell proliferation; however, whole red yeast rice and pigment-rich red yeast rice also decreased colon cancer cell proliferation. This suggests that there are components in red yeast rice, other than just monacolins, that inhibit cancer cell proliferation.³⁹ Other than colorectal cancer, red yeast rice is being investigated for use in risk reduction for prostate cancer. Similar to the colorectal cancer results, there is evidence to suggest that components other than the monacolins in red yeast rice decreased androgen-dependent and -independent prostate cancer growth.⁴⁰ A study in mice with prostate cancer showed that there was a decrease in tumor size in those receiving red yeast rice in comparison to those mice that received placebo.⁴¹ Because some prostate cancers are slow growing, the treatment regimen includes watchful waiting. This group of prostate cancer patients could benefit from the use of red yeast rice to prevent tumor progression.⁴² Patients with slow-growing prostate cancer, where watchful waiting is being used, could particularly benefit from chronic treatment with red yeast rice. Other studies have shown red yeast rice to have cytotoxic properties. One study on human cancer cells established that a specific compound called ankaflavin, a component of red yeast rice, exhibited cytotoxic effects.⁴³ Also, a study in mice with lung cancer cells and induced skin cancer also showed cytotoxic effects.^44,45 However, the use of red yeast rice to prevent cancer or slow tumor progression is still in the early stages, and more research needs to be done to delineate its role in cancer.

Red yeast rice has been shown to have antioxidant properties. Dimerumic acid, a component of red yeast rice, has been used. In molecular studies, dimerumic acid donates an electron to produce its antioxidant effect, and when dimerumic acid (12 mg/kg) was administered to mice, it was able to reduce drug-induced liver toxicity.^46,47 Constituents of red yeast rice were tested for anti-inflammatory ability in mice with chemically induced inflammation.⁴⁸ All 10 tested constituents exhibited anti-inflammatory properties with varying potency.⁴⁷ In addition, these antioxidant and anti-inflammatory properties could be protective against amyloid β peptide–induced plaques.⁴⁹ Amyloid β peptide plaque formation in the brain can contribute to the development of Alzheimer’s disease. A cellular study found that red yeast rice protected cells from the effects of the amyloid β peptide.⁴⁹ When studied in rats, red yeast rice was found to reverse the memory loss caused by amyloid β peptide.⁵⁰ The antioxidant and anti-inflammatory properties of red yeast rice could also be applicable in other disease states.

Summary

Red yeast rice has been shown in multiple clinical studies to be an efficacious option in decreasing serum lipid levels in patients with dyslipidemia, with the greatest effect being on LDL cholesterol. Also, it seems to be a safe, viable option in patients unable to tolerate statins because of myalgias and/or other statin-related side effects. Currently, red yeast rice is the only supplement that has been proven to reduce the occurrence of adverse cardiac events in a comparable degree to statins. Recent research has been conducted that points to increase in the potential use of red yeast rice in other disease states. These studies have amplified its clinical applicability and role as a dietary supplement. Despite these favorable effects, a limitation to using red yeast rice is the lack of consistency in ingredients between different manufacturers and the inability to determine appropriate dosing.

Footnotes

All authors have contributed to this article. MEM completed the first draft, outline, abstract, and references. RSP completed other clinical implications of red yeast rice and provided edits. KLD completed the introduction and pharmacology and provided edits.

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The authors received no financial support for the research, authorship, and/or publication of this article.

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A Review and Update of Red Yeast Rice

Abstract

Keywords

Pharmacology

Clinical Efficacy of Red Yeast Rice for Dyslipidemia

Safety of Red Yeast Rice for Dyslipidemia

Other Clinical Implications for Red Yeast Rice

Summary

Footnotes

References