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Cited by 169Lipoproteins and Cardiovascular HealthNatural Products and Biological ResearchCholesterol and Lipid Metabolism

Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction but safety is uncertain – A systematic review and meta-analysis

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Gerards, Maaike C., Terlou, Ruben J., Yu, Huixin, Koks, C.H.W., Gerdes, V.E.A.·2015·Atherosclerosis
DOI 10.1016/j.atherosclerosis.2015.04.004
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Abstract

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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  • Red yeast rice supplementation reduces LDL-C on average by 1.02 mmol/L compared to placebo, not different from moderate-intensity statins.

    “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]

  • For all previously mentioned studies, there were no safety concerns.

    “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]

  • RYR 1,200-4,800 mg/day with known monacolin K content was tested against placebo or active control in 20 selected RCTs.

    “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]

  • After 4 weeks, RYR reduced LDL-C by 1.02 mmol/l (39 mg/dl) versus placebo, and its LDL effect did not differ from statin therapy.

    “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]

  • Muscular symptom incidence was lower in RYR groups (0-23.8%) than control groups (0-36%).

    “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]

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Research works printed but not linked: 1

  1. J. Higgins, J. Deeks, Obtaining standard deviations from standard errors and confidence intervals for group means, in: J. Higgins, S. Green (Eds.), Cochrane Handbook for Systematic Reviews of Interventions. Version 5, The Cochrane Collaboration, 2011, 7.7.3.3.

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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.
ORCID
Venue
Atherosclerosis
Publisher
Elsevier BV
Published
2015-06
Volume
240
Issue
2
Pages
415-423
ISSN
0021-9150 (ISSN-L)
DOI
10.1016/j.atherosclerosis.2015.04.004
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
Licence
Locations
  • Atherosclerosis (publishedVersion)
  • PubMed (publishedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Health Sciences › Medicine › Surgery › Natural Products and Biological Research
  • Health Sciences › Medicine › Surgery › 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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