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

• Published in: Atherosclerosis Vol. 240; no. 2; pp. 415 - 423
• Main Authors: Gerards, Maaike C, Terlou, Ruben J, Yu, Huixin, Koks, C.H.W, Gerdes, V.E.A
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier Ireland Ltd 01.06.2015
• Subjects: Anticholesteremic Agents - adverse effects; Anticholesteremic Agents - therapeutic use; Biological Products - adverse effects; Biological Products - therapeutic use; Biomarkers - blood; Cardiovascular; Cardiovascular risk reduction; Chi-Square Distribution; Cholesterol; Cholesterol, LDL - blood; Complementary and alternative medicine; Dietary Supplements - adverse effects; Drug safety; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypercholesterolemia - blood; Hypercholesterolemia - diagnosis; Hypercholesterolemia - drug therapy; Lovastatin - therapeutic use; Medicine, Chinese Traditional; Odds Ratio; Risk Assessment; Risk Factors; Treatment Outcome; Cardiovascular risk reduction; Complementary and alternative medicine; Drug safety; Cholesterol
• ISSN: 0021-9150; 1879-1484
• DOI: 10.1016/j.atherosclerosis.2015.04.004

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.