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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.

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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  • Authors+Show Affiliations

    ,

    Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands. Electronic address: maaike.gerards@slz.nl.

    ,

    Department of Pathology, Academical Medical Centre (AMC), Amsterdam, The Netherlands.

    ,

    Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.

    ,

    Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.

    Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands.

    Source

    Atherosclerosis 240:2 2015 Jun pg 415-23

    MeSH

    Anticholesteremic Agents
    Biological Products
    Biomarkers
    Chi-Square Distribution
    Cholesterol, LDL
    Dietary Supplements
    Humans
    Hydroxymethylglutaryl-CoA Reductase Inhibitors
    Hypercholesterolemia
    Lovastatin
    Medicine, Chinese Traditional
    Odds Ratio
    Risk Assessment
    Risk Factors
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Meta-Analysis
    Review
    Systematic Review

    Language

    eng

    PubMed ID

    25897793

    Citation

    Gerards, Maaike C., et al. "Traditional Chinese Lipid-lowering Agent Red Yeast Rice Results in Significant LDL Reduction but Safety Is Uncertain - a Systematic Review and Meta-analysis." Atherosclerosis, vol. 240, no. 2, 2015, pp. 415-23.
    Gerards MC, Terlou RJ, Yu H, et al. Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction but safety is uncertain - a systematic review and meta-analysis. Atherosclerosis. 2015;240(2):415-23.
    Gerards, M. C., Terlou, R. J., Yu, H., Koks, C. H., & Gerdes, V. E. (2015). Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction but safety is uncertain - a systematic review and meta-analysis. Atherosclerosis, 240(2), pp. 415-23. doi:10.1016/j.atherosclerosis.2015.04.004.
    Gerards MC, et al. Traditional Chinese Lipid-lowering Agent Red Yeast Rice Results in Significant LDL Reduction but Safety Is Uncertain - a Systematic Review and Meta-analysis. Atherosclerosis. 2015;240(2):415-23. PubMed PMID: 25897793.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction but safety is uncertain - a systematic review and meta-analysis. AU - Gerards,Maaike C, AU - Terlou,Ruben J, AU - Yu,Huixin, AU - Koks,C H W, AU - Gerdes,V E A, Y1 - 2015/04/12/ PY - 2015/01/22/received PY - 2015/04/02/revised PY - 2015/04/02/accepted PY - 2015/4/22/entrez PY - 2015/4/22/pubmed PY - 2016/3/5/medline KW - Cardiovascular risk reduction KW - Cholesterol KW - Complementary and alternative medicine KW - Drug safety SP - 415 EP - 23 JF - Atherosclerosis JO - Atherosclerosis VL - 240 IS - 2 N2 - 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. SN - 1879-1484 UR - https://www.unboundmedicine.com/medline/citation/25897793/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0021-9150(15)00222-1 DB - PRIME DP - Unbound Medicine ER -