A Placebo-Controlled,
Double-Blind Clinical Trial.
Study conducted by: Shucun
Qin(1), Weiqiang Zhang (1), Peng Qi (1), Meiling Zhao (1),
Zhennan Dong (1), Yongchang Li (2), Xiaoman Zu (3), Zin Fang
(2), Lei Fu (1), Jia-Shi Zhu (4) and Joseph Chang
(4).
This double-blind, placebo-controlled
clinical trial evaluated the ability of a natural product, a
Monascus purpureus (Red Yeast) rice preparation, to regulate
blood lipids in elderly patients with primary hyperlipidemia.
Seventy patients were randomly assigned to two groups: a
M. purpureus rice preparation group and a placebo control
group, 35 patients each group.
Sixty-five patients
completed the trial, 34 in the M. purpureus rice group and 31
in the placebo group. After eight weeks, Monascus Purpureus
rice preparation (1.2 g/day) significantly reduced serum total
cholesterol by 25.9% and LDL-cholesterol by 32.8% (both
p<0.001), whereas the control group (1.2 g/day placebo)
showed 6.5% and 7.9% reductions, respectively.
Notably
this M. Purpureus rice preparation, after 8 weeks lowered
serum triacylglycerols by 19.9% (p=0.02), this was
significantly (p=0.006) from the 2.3% increase observed in
controls. When the overall effect of M. purpureus rice
preparation was assesed relative to causing a change in the
value of one or more lipid risk factors, 91.2 % of patients in
the treatment group showed a significant improvement in their
lipid profile.
Few side effects were
observed during the 8-week treatment with M. Purpureus (Red
Yeast) rice preparation. We concluded that use of M. purpureus
rice preparation as a dietary supplement is safe in elderly
and may represent an effective, novel modality to manage
elevated serum cholesterol and triacylglycerols that influence
cardiovascular health.
(1) PLA General Hospital, Beijing. 100853
Peop1e's Republic of China.
(2) Beijing No.22 Taipinglu Clinic,
Beijing People's Republic of China.
(3) The Clinic of Beijing Institute of
Canbao Architectural Designing, Beijing, People's Republic of
China
(4) Pharmanex Inc. Simi Valley,
California, USA
