title: 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.
authors.affiliation: Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands. Electronic address: maaike.gerards@slz.nl.
authors.forename: Maaike C
authors.initials: MC
authors.lastname: Gerards
authors.affiliation: Department of Pathology, Academical Medical Centre (AMC), Amsterdam, The Netherlands.
authors.forename: Ruben J
authors.initials: RJ
authors.lastname: Terlou
authors.affiliation: Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
authors.forename: Huixin
authors.initials: H
authors.lastname: Yu
authors.affiliation: Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
authors.forename: C H W
authors.initials: CH
authors.lastname: Koks
authors.affiliation: Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands.
authors.forename: V E A
authors.initials: VE
authors.lastname: Gerdes
mesh_terms: D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D008078:Cholesterol, LDL / Q000097:blood; D019587:Dietary Supplements / Q000009:adverse effects; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D006937:Hypercholesterolemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D008148:Lovastatin / Q000627:therapeutic use; D008516:Medicine, Chinese Traditional; D016017:Odds Ratio; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D001688:Biological Products; D015415:Biomarkers; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C117343:red yeast rice; D008148:Lovastatin
keywords: Cardiovascular risk reduction; Cholesterol; Complementary and alternative medicine; Drug safety