The DOI matches its Crossref record; 63 of the 65 references it cites were found in a registry or an index.
Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction but safety is uncertain – A systematic review and meta-analysis
Open accessAbstract
Objective To verify the safety and effectiveness of traditional Chinese red yeast rice-extract (RYR) for reduction of LDL cholesterol.Methods Systematic literature review and meta-analysis. Medline and EMBASE were searched until November 2014. We selected randomized studies in which RYR with a known content of the active substance monacolin K was tested against placebo or an active control group. Outcome measures were the effect of RYR on LDL cholesterol and incidence of adverse reactions with emphasis on liver and kidney injury and muscle symptoms.Results Twenty studies were analyzed. Quality of safety assessment was low in the majority of studies. RYR lowered LDL cholesterol with 1.02 mmol/L [-1.20; -0.83] compared to placebo. Effect of RYR on LDL was not different from statin therapy (0.03 mmol/L [-0.36; 0.41]). The incidence of liver and kidney injury was 0-5% and the risk was not different between treatment and control groups (risk difference -0.01 [-0.01; 0.0] and 0.0 [-0.01; 0.02]).Conclusions RYR exerts a clinically and statistically significant reduction of 1.02 mmol/L LDL cholesterol. Only when the mild profile of adverse reactions can be affirmed in studies with adequate methodology for safety assessment, RYR might be a safe and effective treatment option for dyslipidemia and cardiovascular risk reduction in statin intolerant patients.
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In the citing paper
“A meta-analysis of 20 RCTs evaluated the efficacy of RYR supplementation after 2–24 months that reduced LDL-C on average of 1.02 mmol/L (− 1.20; − 0.83) (39.4 mg/dL) compared to placebo which was not different from moderate-intensity statins (pravastatin 40 mg, simvastatin 10 mg, lovastatin 20 mg) (0.003 mmol/L; − 0.36; 0.41) (0.12 mg/dL).”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [36]
In the citing paper
“For all previously mentioned studies, there were no safety concerns (80,126-130).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [80]
In the citing paper
“RYR (1,200 to 4,800 mg/day) with a known content of the active substance monacolin K (4.8 and 24 mg) was tested against placebo or an active control group in 20 selected RCTs (80).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [80]
In the citing paper
“After 4 weeks, RYR reduced LDL-C by 1.02 mmol/l (39 mg/dl; p < 0.0001) compared with placebo, and the effect of RYR on LDL was not different from statin therapy (0.03 mmol/l [1.2 mg/dl]; p ¼ 0.89) in statin-”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [80]
In the citing paper
“The incidence of developing muscular symptoms was lower in RYR groups (0% to 23.8%) compared with control groups (0% to 36%).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [80]
In the citing paper
“There were no cases of rhabdomyolysis or myopathy with creatine kinase levels >10 times the upper limit of normal (80).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [80]
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“These metabolites are associated with numerous beneficial biological activities, including cholesterol modulation (Gerards et al., 2015 ), blood glucose regulation (Rajasekaran & Kalaivani, 2015 ), blood pressure management (Kuba et al., 2009 ), therapeutic benefits such as anticancer (Kurokawa et…”
BackgroundRed yeast rice with monacolin K for the improvement of hyperlipidemia: A narrative review
English, K. J. (2025) · World Journal of Clinical Cases · doi:10.12998/wjcc.v13.i27.105415 · Cited by 7
“…a meta-analysis regarding the safety and efficacy of RYR in treating hyperlipidemia using 15 Another meta-analysis of 20 RCTs by Gerards et al [57] involving more than 6000 patients revealed that RYR (1200-4800 mg/day) was better than a placebo at decreasing TC (MD: -1.00 mmol/L; 95%CI: -1.23…”
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“As an alternative therapeutic regimen to chemical drugs, several herbs, nutraceutical ingredients and functional foods have been used to lower serum cholesterol levels and to reduce the risk of CHD [5, 6].”
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Effects of Monacolin K in Nondiabetic Patients with NAFLD: A Pilot Study
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“Thus, the present findings are in full agreement with those of previous studies [15,34] and support the evidence that monacolin K is an effective molecule for hypercholesterolemia and a reasonable alternative for treatment of statinintolerant patients.”
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“Complementarily, Gerard et al. [8] reported that RYR extract enriched with MK reduced LDL-C levels by 1.02 mmol/L, highlighting its therapeutic potential as a safe and effective option for hypercholesterolemia management, especially in patients with statin intolerance, and underscoring its role in…”
InfluentialRenal Injuries Induced by Supplements Containing Red Yeast Rice
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“Our results were consistent with literature evidence [31, 32].”
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“Meta-analysis and randomized trials using RYR have repeatedly shown significant beneficial health effects such as reducing total serum cholesterol (TC), low-density lipoprotein (LDL), and triglycerides (TG) [24-27].”
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Fungus Monascus-Fermented Red Yeast Rice (RYR): Natural Therapeutic Statin Source or Mycotoxin?
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Monacolin K – a natural statin
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Blepharoptosis and Cholesterol-Lowering Medications: A Retrospective Study
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“Er enthält den Wirkstoff Monacolin K (Lovastatin), der eine Hemmung der HMG-CoA-Reduktase bewirkt [28].”
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“Several reports indicated that RYR possesses hypolipidemic [20], antihypertensive [21], anti-osteoporotic [22], hepatoprotective [23] and antidiabetic [24] activities.”
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Metadata
- Authors
- Gerards, M. C., Terlou, R. J., Yu, H., Koks, C. H. W., & Gerdes, V. E. A.
- Affiliations
- Slotervaartziekenhuis (NL)
- Amsterdam UMC Location University of Amsterdam (NL)
- The Netherlands Cancer Institute (NL)
- Corresponding author
- Gerards, Maaike C.
- Venue
- Atherosclerosis
- Publisher
- Elsevier BV
- Published
- 2015-06
- Volume
- 240
- Issue
- 2
- Pages
- 415-423
- ISSN
- 0021-9150 (ISSN-L)
- OpenAlex
- W1973557710
- Cited by
- 169
- References
- 65
- Citations by year
- 2026: 6 · 2025: 11 · 2024: 18 · 2023: 17 · 2022: 15 · 2021: 23 · 2020: 19 · 2019: 13 · 2018: 14 · 2017: 15 · 2016: 14 · 2015: 3
- FWCI
- 2.94
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Atherosclerosis (publishedVersion)
- PubMed (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Natural Products and Biological Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
- Keywords
- red yeast rice, lovastatin, LDL cholesterol lowering, lipid-lowering drugs, drug safety, adverse drug reactions, liver injury, kidney injury, muscle symptoms, statin intolerance, dyslipidemia, cardiovascular risk reduction
- MeSH terms
- Anticholesteremic Agents, Biological Products, Humans, Hypercholesterolemia, Cholesterol, LDL, Lovastatin, Medicine, Chinese Traditional, Risk Factors, Biomarkers, Chi-Square Distribution, Odds Ratio, Treatment Outcome, Risk Assessment, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Dietary Supplements
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