Open Access Highly Accessed Research article

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

Veronique Verhoeven1*, Maja Lopez Hartmann1, Roy Remmen1, Johan Wens1, Sandra Apers2 and Paul Van Royen1

Author Affiliations

1 The academic center for primary and interdisciplinary care, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium

2 Natural products and food – Research & Analysis, Faculty of Pharmaceutical, Biomedical and Veterinary Sciences, Universiteitsplein 1, Wilrijk 2610, Belgium

For all author emails, please log on.

BMC Complementary and Alternative Medicine 2013, 13:178  doi:10.1186/1472-6882-13-178

Published: 18 July 2013

Abstract

Background

In 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.

Methods

In 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.

Results

LDL (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).

Conclusions

The 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 registration

Clinicaltrials.gov, nr: NCT01558050

Keywords:
Cardiovascular prevention; Statins; Red yeast rice; Cholesterol