title: Red yeast rice lowers cholesterol in physicians - a double blind, placebo controlled randomized trial.
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.
  
  
  BACKGROUND
  Clinicaltrials.gov, nr: NCT01558050.
authors.forename: Veronique
authors.initials: V
authors.lastname: Verhoeven
authors.forename: Maja
authors.initials: M
authors.lastname: Lopez Hartmann
authors.forename: Roy
authors.initials: R
authors.lastname: Remmen
authors.forename: Johan
authors.initials: J
authors.lastname: Wens
authors.forename: Sandra
authors.initials: S
authors.lastname: Apers
authors.forename: Paul
authors.initials: P
authors.lastname: Van Royen
mesh_terms: D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000494:pharmacology* / Q000627:therapeutic use; D001203:Ascomycota; D001688:Biological Products / Q000494:pharmacology* / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000209:etiology; D002784:Cholesterol / Q000097:blood*; D008078:Cholesterol, LDL / Q000097:blood; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000494:pharmacology* / Q000627:therapeutic use; D006937:Hypercholesterolemia / Q000097:blood* / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010820:Physicians; D012307:Risk Factors
chemical_list: D000924:Anticholesteremic Agents; D001688:Biological Products; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C117343:red yeast rice; D002784:Cholesterol