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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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“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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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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