Efficacy and safety of Monascus purpureus Went rice in subjects with hyperlipidemia.
OBJECTIVE
The purpose of this study was to assess the lipid-lowering effect of Monascus purpureus Went rice on serum lipids in patients with hyperlipidemia, and to assess its safety by reporting adverse events and clinical laboratory measurements.


METHODS
This was a randomized, double-blind, placebo-controlled study. In all, 79 patients (aged 23-65 years) with a mean baseline low-density lipoprotein cholesterol (LDL-C) level of 5.28 mmol/l (203.9 mg/dl) received a twice daily dose of placebo or Monascus purpureus Went rice (600 mg) for 8 weeks.


RESULTS
At week 8, Monascus purpureus Went rice therapy reduced LDL-C by 27.7%, total cholesterol by 21.5%, triglycerides by 15.8% and apolipoprotein B by 26.0%. High-density lipoprotein cholesterol and apolipoprotein A-I levels were increased by 0.9 and 3.4% respectively (not significant). No patient in the Monascus purpureus Went rice treatment group had an alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatine phosphokinase (CPK) measurement that was > or = 3 times the upper limit of normal at week 4 and week 8.


CONCLUSIONS
Monascus purpureus Went rice significantly reduced LDL-C, total cholesterol, triglycerides and apolipoprotein B levels, and was well tolerated in patients with hyperlipidemia. However, this study only provides data from an 8-week trial and long-term safety and efficacy data are needed.
Lin
Cheng-Chieh
CC
Department of Family Medicine, China Medical University Hospital, Taichung 40447, Taiwan.
Li
Tsai-Chung
TC
Lai
Ming-May
MM
D000328:Adult; D001055:Apolipoproteins B / Q000097:blood; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005285:Fermentation; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000178:diet therapy*; D008297:Male; D008516:Medicine, Chinese Traditional / Q000009:adverse effects; D008875:Middle Aged; D032741:Monascus / Q000502:physiology*; D012275:Oryza / Q000009:adverse effects / Q000378:metabolism* / Q000382:microbiology*; D012449:Safety; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D001055:Apolipoproteins B; D008078:Cholesterol, LDL; D014280:Triglycerides; D002784:Cholesterol