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A systematic review and meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of red yeast rice's effect on total cholesterol, LDLLow-density lipoprotein cholesterol - the so-called "bad" cholesterol., HDL, and triglycerideA type of fat in the blood; high levels raise cardiovascular risk.s in adults. Searching four databases (SCOPUS, PubMed/MEDLINE, EMBASE, Web of Science) through December 2021 and screening 3,623 articles, it included 24 treatment arms from randomized controlled trialA high-reliability trial randomly assigning participants to compare effects (RCT).s. Pooled, red yeast rice lowered total cholesterol by 33.16 mg/dL, LDL by 28.94 mg/dL, and triglycerides by 23.36 mg/dL while raising HDL by 2.49 mg/dL, all at P<0.001. Effects were larger at doses under 1,200 mg, with interventions shorter than 12 weeks, and in people with dyslipidemiaBlood lipid levels (cholesterol, triglycerides) outside the normal range..

Key summary

A meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of red yeast rice's efficacy and safety in hyperlipidemia. Searching PubMed, Embase, and the CochraneAn international network that rigorously reviews and synthesizes evidence. Central Register and including only high-quality randomized trials comparing red yeast rice with non-red-yeast-rice interventions, it covered 1,012 participants (481 experimental, 531 control). Against statinA common lipid-lowering drug that reduces LDL cholesterol.s, red yeast rice lowered triglycerideA type of fat in the blood; high levels raise cardiovascular risk.s more (mean difference -19.90), was comparable for LDLLow-density lipoprotein cholesterol - the so-called "bad" cholesterol. reduction and HDL increase, and lowered total cholesterol less (+12.24). Against other nutraceuticals it significantly reduced total cholesterol (-17.80) and LDL (-14.40) and raised HDL (+7.60), and combined with a nutraceutical it further reduced total cholesterol (-31.10), LDL (-27.91), and triglycerides (-26.32). It also reduced apoB by 27.98 and did not increase adverse event risk alone or in combination. The authors concluded that 200 to 4,800 mg daily appears safe and effective while calling for higher-quality trials with longer observation.

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A meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of red yeast rice extract and cardiovascular outcomes in myocardial infarctionA heart attack - death of heart muscle from blocked blood flow. patients with borderline hypercholesterolemia. Searching PubMed, CENTRAL, CINAHL, Scopus, Web of Science, and ClinicalTrials.gov through May 2019, it included seven studies covering 10,699 patients, with follow-up from 4 weeks to 4.5 years and studies judged overall high quality with low risk of bias. Extract at 1,200 mg a day reduced non-fatal myocardial infarction (risk ratio 0.42), revascularization (0.58), and sudden death (0.71). On lipids, LDLLow-density lipoprotein cholesterol - the so-called "bad" cholesterol. fell 20.70 mg/dL, total cholesterol 26.61 mg/dL, and triglycerideA type of fat in the blood; high levels raise cardiovascular risk.s 24.69 mg/dL, while HDL rose 2.71 mg/dL. The authors concluded that red yeast rice extract in these patients is associated with improved cardiovascular outcomes and lipid profiles.

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A trial at a community-based cardiology practice randomizing 62 patients with dyslipidemiaBlood lipid levels (cholesterol, triglycerides) outside the normal range. who had discontinued statinA common lipid-lowering drug that reduces LDL cholesterol.s because of myalgia to red yeast rice 1,800 mg twice daily (31 patients) or placeboAn inert dummy treatment used as the comparison baseline. (31 patients) for 24 weeks, with all participants also enrolled in a 12-week therapeutic lifestyle change program. In the red yeast rice group, LDLLow-density lipoprotein cholesterol - the so-called "bad" cholesterol. cholesterol fell 1.11 mmol/L (43 mg/dL) from baseline at week 12 and 0.90 mmol/L (35 mg/dL) at week 24, versus 0.28 mmol/L (11 mg/dL) and 0.39 mmol/L (15 mg/dL) with placebo. LDL was significantly lower in the red yeast rice group at both time points, with a significant treatment effect on total cholesterol as well. HDL, triglycerideA type of fat in the blood; high levels raise cardiovascular risk.s, liver enzymes, CPK, weight loss, and pain severity scores did not differ significantly. The authors noted the study was small, single-site, short, and focused on laboratory measures.

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A trial comparing tolerability in 43 adults with dyslipidemiaBlood lipid levels (cholesterol, triglycerides) outside the normal range. who had stopped statinA common lipid-lowering drug that reduces LDL cholesterol.s because of myalgia, randomized to red yeast rice 2,400 mg twice daily or pravastatin 20 mg twice daily for 12 weeks in a community-based setting in Philadelphia, with all subjects also in a 12-week therapeutic lifestyle change program. The primary outcomes, withdrawal for myalgia and daily pain severity, showed no difference: 5 percent (1 of 21) with red yeast rice versus 9 percent (2 of 22) with pravastatin (p=0.99), and similar mean pain severity. Muscle strength did not differ at weeks 4, 8, or 12. LDLLow-density lipoprotein cholesterol - the so-called "bad" cholesterol. cholesterol fell 30 percent with red yeast rice and 27 percent with pravastatin. The conclusion was that red yeast rice was tolerated as well as pravastatin and achieved a comparable LDL reduction in a previously statin-intolerant population.

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An analysis of monacolin content and citrinin contamination in 12 commercial red yeast rice products widely used as an alternative for hyperlipidemia. Red yeast rice contains 14 active compounds called monacolins that inhibit hepatic cholesterol synthesis, yet levels are not standardized across marketed products and are generally not published on labels. All 12 were labeled 600 mg per capsule and were analyzed between August 2006 and June 2008 by high-performance liquid chromatography with mass spectrometry. Total monacolins ranged from 0.31 to 11.15 mg per capsule, monacolin K (lovastatinA common lipid-lowering drug that reduces LDL cholesterol.) from 0.10 to 10.09 mg, and monacolin KA from 0.00 to 2.30 mg, and four products had elevated levels of citrinin, a mycotoxin that is nephrotoxic in animals. The authors concluded that until standardization and labeling improve, physicians should be cautious about recommending red yeast rice.

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A screening of mycotoxin and natural statinA common lipid-lowering drug that reduces LDL cholesterol. content in 37 red yeast rice food supplements sold online and in retail across the European Union, including both pure capsules and multi-ingredient formulations with standardized monacolin K. Citrinin was found in all monitored products, ranging from 100 to 25,100 μg/kg. Only four complied with the EU maximum levels in force until April 2020, and a single product complied with the 100 μg/kg limit introduced afterwards, while four contaminated products were labeled citrinin free. On natural statins, nine products contained 30 to 83 percent less monacolin K than stated and 24 contained 10 to 266 percent more, with three having negligible monacolin K. No sample had label values compliant with pharmaceutical Good Manufacturing Practices, which require 95 to 105 percent of the active constituent. The authors argue that an under-regulated and under-controlled market weakens both effectiveness and risk assessment.

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A review reanalyzing serious adverse events linked to red yeast rice, specifically rhabdomyolysis and acute hepatitis, using adverse event reporting system data. Red yeast rice lowers cholesterol because its bioactive monacolins inhibit HMG-CoA reductase. In August 2018, amended in June 2022, the European Food Safety Authority concluded that monacolins from red yeast rice raise significant safety concerns when used as a food supplement at 10 mg a day, noting individual cases of serious adverse effects reported at intakes as low as 3 mg a day, while the EFSA Panel pointed to several uncertainties in the available data. The authors' analysis of the FDA reporting systems revealed a very small number of rhabdomyolysis or severe acute hepatitis cases associated with red yeast rice, with only a few published case reports. Their conclusion is that the occurrence of these serious events appears extremely rare compared with the occurrence with statinA common lipid-lowering drug that reduces LDL cholesterol.s, which is rare to common.