Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction but safety is uncertain - a systematic review and meta-analysis.
OBJECTIVETo verify the safety and effectiveness of traditional Chinese red yeast rice-extract (RYR) for reduction of LDL cholesterol.
METHODSSystematic 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.
RESULTSTwenty 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]).
CONCLUSIONSRYR 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.
Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands. Electronic address: firstname.lastname@example.org.,
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.
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Medicine, Chinese Traditional
Pub Type(s)Journal Article