Research - Red Yeast Rice
Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols, and Berberine) in Patients with Low-Moderate Risk Hypercholesterolemia: A Double-Blind, Placebo-Controlled Study
Statins are at the forefront of strategies to manage hypercholesterolemia. However 10% to 15% of patients are intolerant to any statin drugs, even at low daily doses and almost one-third of statin users discontinue therapy within 1 year. Some nutraceuticals are prescribed as lipid-lowering substances, but doubts remain about their efficacy and tolerability.
We aimed to investigate the efficacy and the safety of a nutraceutical combination consisting mainly of 200 mg red yeast rice extract (equivalent to 3 mg monacolins), 500 mg berberine, and 10 mg policosanols (MBP-NC) in patients with low-moderate risk hypercholesterolemia.
In this single centre, randomized, double-blind, placebo-controlled study 60 consecutive outpatients (29 men and 31 women; age range = 18–60 years), with newly diagnosed primary hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable hypolipidic diet, were randomized to receive a pill of MBP-NC (n = 30) or placebo (n = 30) once a day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability of the proposed nutraceutical treatment were fully assessed after 4, 12, and 24 weeks of treatment.
In the MBP-NC group both total cholesterol and LDL-C already showed a significant reduction at Week 4 (–30.3% ± 33.9% and –29.4% ± 35.3%, respectively) that remained substantially unchanged at Week 12 (–26.7% ± 33.1% and –25.6% ± 31.5%, respectively) and at Week 24 (–24.6% ± 32.1% and –23.7% ± 32.6%, respectively). The between-groups differences were significant at all time points for both total cholesterol and LDL-C. There were no significant changes in HDL-C, fasting glucose, and triglyceride serum levels in either group. MBP-NC was also safe and well tolerated.
In patients with low- to moderate-risk hypercholesterolemia a nutraceutical combination in association with a hypolipidic diet significantly reduced total cholesterol and LDL-C levels and may favor the reaching the recommended cholesterol targets.
Source : Current Therapeutic Research
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A Review and Update of Red Yeast Rice
Megan E. Musselman, PharmD, BCPS1, Rebecca S. Pettit, PharmD, MBA, BCPS2, and Karrie L. Derenski, PharmD, BCNSP, CNSC3
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.
Source : Journal of Evidence-Based Complementary & Alternative Medicine
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Red Yeast Rice Strength of Evidence
- Some red yeast rice products contain substantial amounts of monacolin K, which is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin. Available evidence on the cholesterol-lowering effects of red yeast rice has focused on these products.
- Researchers have not reported results of any studies of red yeast rice products that contain little or no monacolin K, so whether these products have any effect on blood cholesterol is unknown.
- Red yeast rice products containing substantial amounts of monacolin K, which is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin, may lower blood cholesterol levels and can cause the same types of side effects and drug interactions as lovastatin. The U.S. Food and Drug Administration (FDA) has determined that red yeast rice products that contain more than trace amounts of monacolin K cannot be sold legally as dietary supplements.
- Other red yeast rice products contain little or no monacolin K. It is not known whether these products have any effect on blood cholesterol levels.
- Consumers have no way of knowing how much monacolin K is actually present in most red yeast rice products. The labels on these products usually state only the amount of red yeast rice that they contain, not the amount of monacolin K.
- The same types of side effects that can occur in patients taking the drug lovastatin can also occur in patients who take red yeast rice products that contain monacolin K. Potential side effects include myopathy (muscle symptoms such as pain and weakness), rhabdomyolysis (a condition in which muscle fibers break down, releasing substances into the bloodstream that can harm the kidneys), and liver toxicity. Each of these three side effects has been reported in people who were taking red yeast rice.
- Red yeast rice supplements should not be used while pregnant or breastfeeding.
- It is known that lovastatin can interact with a variety of drugs to increase the risk of rhabdomyolysis; these drugs include other cholesterol-lowering agents, certain antibiotics, the antidepressant nefazodone, drugs used to treat fungal infections, and drugs used to treat HIV infection. It is likely that red yeast rice products containing monacolin K could interact with these or other drugs in the same way.
- If the process of culturing red yeast rice is not carefully controlled, a substance called citrinin can form. Citrinin has been shown to cause kidney failure in experimental animals and genetic damage in human cells. In a 2011 analysis of red yeast rice products sold as dietary supplements, 4 of 11 products were found to contain this contaminant.
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