Red yeast rice lowers cholesterol in physicians - a double blind, placebo controlled randomized trial.

Veronique Verhoeven,Roy Remmen,Johan Wens,Maja Lopez Hartmann,Sandra Apers,Paul Van Royen

doi:10.1186/1472-6882-13-178

Veronique Verhoeven, Roy Remmen + Show 4 more

Open Access

https://doi.org/10.1186/1472-6882-13-178

Copy DOI

Abstract

BackgroundIn recent years, red yeast rice (RYR) supplements have been marketed aggressively as a natural way to lower cholesterol; however, the large majority of commercially available products have not been studied according to current research standards.MethodsIn a double blind placebo controlled randomized trial, 52 physicians and their spouses with a total cholesterol level of > 200 mg/dL were randomly allocated to receive a RYR extract or placebo for 8 weeks. As a primary outcome measure, we compared the before-after difference in lipid levels between both groups. As secondary outcome measures we looked at side-effects, CK elevation and a change in cardiovascular risk.ResultsLDL (low density lipoprotein) cholesterol was lowered with 36 mg/dL (22%) and total cholesterol with 37 mg/dL (15%) in the intervention group. This result was statistically significant as compared to the control group, in which no reduction in total cholesterol and LDL was observed (p < 0.001). There was no marked difference in CK (creatine kinase)-elevation or reported side-effects between study groups. In 5/31 participants in the intervention group, the lipid lowering effect resulted in lower cardiovascular risk as measured with SCORE (Systematic COronary Risk Evaluation).ConclusionsThe RYR formulation under study was effective in lowering cholesterol and LDL cholesterol in this study population. RYR therapy may be an attractive and relatively well studied alternative in patients who are intolerant for statins or who have objections against pharmacological lipid lowering. However, consumers need to be warned that the actual content of commercially available preparations is not assured by governmental regulations, which raises effectiveness and safety issues.Trial registrationClinicaltrials.gov, nr: NCT01558050

Highlights

In recent years, red yeast rice (RYR) supplements have been marketed aggressively as a natural way to lower cholesterol; the large majority of commercially available products have not been studied according to current research standards
This process results in the production of a mixture of monacolins, which are inhibitors of hydroxymethylglutarylcoenzyme A (HMG-CoA) reductase and inhibit cholesterol synthesis in the liver
As secondary outcome measures we looked at side-effects, creatine kinase (CK) elevation and a change in cardiovascular risk.Statistical analyses were performed using SPSS, SPSS Inc, Chicago, Illinois, USA

Summary

Introduction

In recent years, red yeast rice (RYR) supplements have been marketed aggressively as a natural way to lower cholesterol; the large majority of commercially available products have not been studied according to current research standards. Whereas the evidence in favor of these products is still being developed and refined, dietary supplement industries have proceeded without delay to produce a number of RYR formulations These food supplements are marketed and mediatized as a “natural” alternative to lipid lowering drugs and as a solution for patients who experience statin-associated myalgia. RYR, which has been used for centuries in China as a food colorant and in traditional medicine “to invigorate the body, aid in digestion, and revitalize the blood” [1], is produced by culturing the yeast Monascuspurpureus on rice This process results in the production of a mixture of monacolins, which are inhibitors of hydroxymethylglutarylcoenzyme A (HMG-CoA) reductase and inhibit cholesterol synthesis in the liver. Monacolin K is chemically identical to the statin commercialized as lovastatin

Methods

Results

Conclusion