Multicenter clinical trial of the serum lipid-lowering effects of a Monascuspurpureus (red yeast) rice preparation from traditional Chinese medicine

Author(s): Wang J, Lu Z, Chi J, Wang W, Su M, et al.


The ability of a natural product Monascus purpureus (red yeast) rice (cholestin3™) preparation to regulate serum lipids was assessed in a multicenter, single-masked clinical trial. A total of 446 patients with hyperlipidemia were randomly assigned to two groups: a group of 324 patients received a M purpureus (red yeast) rice preparation, and a positive control group of 122 patients received another Chinese herbal medicine, Jiaogulan (Gynostemma pentaphylla). After 8 weeks, serum total cholesterol decreased significantly by 22.7% and low-density lipoprotein cholesterol by 30.9% in the patients treated with a M purpureus rice preparation, and patients in the positive control group showed 7.0% and 8.3% reductions, respectively. M purpureus treatment also significantly increased high-density lipoprotein (HDL) cholesterol by 19.9%, which was a significantly larger increase than the 8.4% increase observed in the positive control group. Notably M purpureus rice preparation significantly lowered serum triglycerides by 34.1% after 8 weeks, which was a significantly greater decrease than the reduction of 12.8% observed in the positive control group. When the overall therapeutic effects of M purpureus rice were scored, with one or more lipid risk factors being reduced and HDL cholesterol being increased, according to criteria established by the Ministry of Public Health of China, 93.2% of patients in the treatment group benefited from M purpureus. This total efficacy rate was significantly better than the rate of 50.8% in the positive control group. Therefore, use of M purpureus rice preparation in conjunction with a proper diet produced a favorable lipid-lowering effect in hyperlipidemic patients. The patients experienced a few mild side effects (heartburn, flatulence, and dizziness) during the 8-week treatment with M purpureus rice preparation. We concluded that this traditional Chinese rice preparation used as a dietary supplement is extremely effective and well tolerated in reducing elevated serum cholesterol and triglycerides.

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