Safety and Efficacy of Red Yeast Rice (Monascus purpureus) as an Alternative Therapy for Hyperlipidemia

Matthew Klimek and Adeleye Ogunkanmi are postdoctoral fellows at Rutgers University Ernest Mario School of Pharmacy in Piscataway, New Jersey. Shan Wang is a clinical pharmacist at Winthrop University Hospital in Mineola, New York.
P&T (Impact Factor: 1.07). 07/2009; 34(6):313-27.
Source: PubMed


Red yeast rice is a Chinese fermented rice product (Monascus purpureus) that some have claimed improves blood circulation by decreasing cholesterol and triglyceride levels in humans. The supplement contains naturally occurring monacolin K, the active ingredient found in Merck's prescription agent lovastatin (Mevacor). Lovastatin is associated with various adverse effects such as myopathy and abnormal liver function test results, which can lead to serious problems if patients are not monitored and treated. The inclusion of lovastatin in red yeast rice and the lack of dietary supplement regulation by the FDA raise safety concerns for health care professionals as well as for patients. Studies have shown that red yeast rice products can be beneficial in lowering serum cholesterol levels, but they are not without risk. Furthermore, product uniformity, purity, labeling, and safety cannot be guaranteed.

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Available from: Shan Wang, Jun 03, 2014
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    • "Several randomized clinical trials using RYR preparations with 3 to 10 mg/d monacolin K have demonstrated a significant cholesterol-lowering effect (Heber, 1999; Zhao, 2004; Liu, 2006; Huang, 2007). While RYR is generally safe, some serious adverse reactions have been reported (Klimek, 2009). The efficacy of SCdP is more controversial; all studies showing a lipid-lowering effect (using 5-40 mg/d policosanols) originate from the same Cuban group (Gouni-Berthold and Berthold, 2002; Chen, 2005), and trials conducted by other groups (10 to 80 mg/d policosanols) have been unable to reproduce these results (Berthold, 2006; Dulin, 2006; Greyling, 2006). "
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    ABSTRACT: Objective: To investigate the effect of a natural cholesterol-lowering supplement (NCLS) containing red yeast rice, policosanols and artichoke leaf extracts on blood lipid concentrations as well as on safety parameters when given over 16 weeks in 100 volunteers with untreated moderate hypercholesterolemia, in a randomized, double-blind, placebo-controlled trial. Results: Reduction of primary outcome low-density lipoprotein cholesterol [-0.22 g/L (95% confidence interval, CI: -0.31 to -0.12) corresponding to -14.3% from baseline (95% CI: -21.5 to -7.2) compared to placebo], as well as total cholesterol, apolipoprotein B100 and apolipoprotein B100/apolipoprotein A-I ratio, were observed after 16 weeks of supplementation with NCLS. These effects were already observed at Week 4 and 10 of supplementation. No significant changes were observed in high-density lipoprotein, triacylglycerol, creatine kinase, lactate dehydrogenase and coenzyme Q10 levels, as well as in markers of liver and renal function. Conclusions: The NCLS was effective in reducing low-density lipoprotein cholesterol and apolipoprotein B100 in subjects with moderate hypercholesterolemia, without modifying safety parameters.
    Full-text · Article · Jul 2013 · International Journal of Food Sciences and Nutrition
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    • "Products with very little monacolin K may have little to no effect on blood cholesterol levels. Although red yeast rice has been marketed to patients intolerant of statin drugs due to those drugs' side effects, there have been case reports of myopathy and rhabdomyolysis associated with red yeast rice [29]. In 1998, the FDA ruled that a red yeast rice product that contained a substantial amount of monacolin K was no longer a dietary supplement but an unapproved new drug and that marketing the product as a dietary supplement would be illegal [1]. "
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    ABSTRACT: Complementary and alternative medicine (CAM) plays a significant role in many aspects of healthcare worldwide, including cardiovascular disease (CVD). This review describes some of the challenges of CAM in terms of scientific research. Biologically-based therapies, mind-body therapies, manipulative and body-based therapies, whole medical systems, and energy medicine are reviewed in detail with regard to cardiovascular risk factors and mediation or modulation of cardiovascular disease pathogenesis. CAM use among patients with CVD is prevalent and in many instances provides positive and significant effects, with biologically-based and mind-body therapies being the most commonly used treatment modalities. More rigorous research to determine the precise physiologic effects and long-term benefits on cardiovascular morbidity and mortality with CAM usage, as well as more open lines of communication between patients and physicians regarding CAM use, is essential when determining optimal treatment plans.
    Full-text · Article · Apr 2013 · Evidence-based Complementary and Alternative Medicine
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    • "Red yeast rice (RYR), a fermented rice product generally produced from a specific strain of red yeast called Monascus purpureus, is a popular complementary medicine used to lower blood lipid levels (Heber et al., 1999; Lin et al., 2005; Liu et al., 2006; Huang et al., 2007; Zhao et al., 2007; Lu et al., 2008). The major active component of RYR is considered to be monacolin K, also known as lovastatin, the active ingredient of the statin drug Mevacor (Merck & Co. Inc., USA) (Klimek et al., 2009). Lovastatin is a prodrug that is converted by esterases to its active form, lovastatin acid, which inhibits the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A reductase, the rate-limiting enzyme in the cholesterol biosynthetic pathway in the liver (Alberts et al., 1980). "
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    ABSTRACT: Lovastatin, categorized as a class II compound according to the Biopharmaceutics Classification System, is mainly responsible for the blood cholesterol lowering effect of red yeast rice (RYR). The aim of this study was to compare the dissolution rate, physical state, and oral bioavailability of lovastatin in three RYR products (LipoCol Forte, Cholestin, or Xuezhikang) to those of two lovastatin tablets (Mevacor or Lovasta). The results showed that the dissolution rate of lovastatin in various dissolution media in the registered RYR products was faster and higher than that of lovastatin in lovastatin tablets. Powder X-ray diffraction and differential scanning calorimetry patterns showed that the crystallinity of lovastatin was reduced in RYR products. In human studies, the AUC and C(max) values for both lovastatin and its active metabolite, lovastatin acid, were significant higher in volunteers receiving LipoCol Forte capsules or powder than in those receiving lovastatin tablets or powder. In addition, shorter and less variable T(max) values were observed in volunteers taking LipoCol Forte than in those taking lovastatin tablets. These findings suggest that the oral bioavailability of lovastatin is significantly improved in RYR products as a result of a higher dissolution rate and reduced crystallinity.
    Full-text · Article · Jan 2013 · International Journal of Pharmaceutics
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