Elderly Patients with Primary Hyperlipidemia Benefited from Treatment with a Monascus purpureus rice preparation.

A Placebo-Controlled, Double-Blind Clinical Trial.

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),>

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

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Cholestin Clinical Study from PubMed

A study was published in this month's issue of the Journal Nutrition, titled "A Pilot Study of the Safety and Efficacy of Cholestin in Treating HIV-Related Dyslipidemia." The study was conducted by the Rush University College of Nursing in Chicago, Illinois. The researchers concluded that after eight weeks, Cholestin (with red yeast rice) significantly lowered total and low-density lipoprotein (LDL) cholesterol (12% and 23%, respectively) in patients with dyslipidemia related to human immunodeficiency virus (HIV).


Reference: Keithley JK, et al. Nutrition 2002;18(2):201-204.

A pilot study of the safety and efficacy of cholestin in treating HIV-related dyslipidemia.

Keithley JK, Swanson B, Sha BE, Zeller JM, Kessler HA, Smith KY.

Rush University College of Nursing, Chicago, Illinois, USA

OBJECTIVE: We collected preliminary safety and efficacy data on the effects of Cholestin, a statin-containing dietary supplement, in individuals with dsylipidemia related to human immunodeficiency virus.

METHODS: Fourteen adults with dsylipidemia related to human immunodeficiency virus characterized by hypercholesterolemia, hypertriacylglycerolemia, or both participated in a randomized, double-blind, placebo-controlled pilot study in an infectious disease clinic based in an academic medical center. Participants were randomly assigned to receive 1.2 g of Cholestin twice daily (n = 7) or placebo (n = 7) for 8 wk. The main outcome measures were safety (hepatic function tests, plasma human immunodeficiency virus-1 RNA levels, CD4(+) cell counts, adverse effects) and efficacy (fasting serum cholesterol: total, high- and low-density lipoproteins, and fasting serum triacylglycerols). Safety and efficacy outcomes were evaluated at 2- and 8-wk intervals.

RESULTS: Twelve participants (n = 6 per group) completed the 8-wk treatment protocol. After 8 wk of treatment with Cholestin, there were significant declines from baseline in mean ([plus minus] standard error of the mean) fasting total cholesterol ([minus sign]30.8 [plus minus] 8.8 versus 7.7 [plus minus] 5.6; P = 0.01) and low-density lipoprotein cholesterol ([minus sign]32.2 [plus minus] 7.2 versus 26.3 [plus minus] 14.2; P = 0.01) versus placebo. Moreover, the decline in fasting total cholesterol was significant ([minus sign]40.2 [plus minus] 4.8 versus 2.8 [plus minus] 11.9; P = 0.006) after 2 wk of therapy, at which time the low-density lipoprotein cholesterol approached significance ([minus sign]30.2 [plus minus] 7.4 versus 4.4 [plus minus] 15.2; P = 0.068). High-density lipoprotein cholesterol and triacylglycerol levels did not change at either time point. No adverse effects were seen with Cholestin.

CONCLUSIONS: Cholestin may safely lower total and low-density lipoprotein cholesterol in patients with dsylipidemia related to human immunodeficiency virus. Larger and longer-term trials of this approach are warranted.

PMID: 11844656 [PubMed - as supplied by publisher]

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Chinese condiment cuts blood cholesterol

American Heart Association’s meeting report:

ORLANDO, Fla, March 25...The spice that gives Peking Duck its distinctive red color seems to lower blood cholesterol, two research teams reported at the American Heart Association's epidemiology and prevention meeting.

In a study conducted in China, an extract of the red yeast fermented on rice, which is sold under the name of Cholestin, reduced total blood cholesterol by nearly 26% in elderly patients after eight weeks of treatment, says the study's lead author, Joseph Chang, Ph.D., vice president of clinical affairs at Pharmanex, Inc. The Simi Valley, California, company imports the dietary supplement to the United States.

"Cholestin also reduced "bad" cholesterol or low density lipoprotein cholesterol (LDL) by 32.8% and decreased by 19.9% triglycerides, a type of blood fat associated with increased risk for heart disease," says Chang.

The average total cholesterol level of study participants was 225 milligrams/deciliter (mg/dL); average LDL was 160 mg/dL and the average triglycerides were 250 mg/dL. LDL is called the "bad" cholesterol because it collects in the blood vessels to form plaque that can block blood flow, triggering a heart attach or stroke. Individuals who did not receive the supplement had reductions of total blood cholesterol and LDL of about 7%, says Chang.

James Rippe, M.D., an associate professor of medicine at Tufts University School of Medicine in Boston, reports similar results in a second study that was conducted in 12 Medical Centers and funded by Pharmanex. He reported that after 8 weeks on Cholestin, individuals had a 16.4% drop in total blood cholesterol. There LDL decreased by 21%, and HDL-cholesterol, the "good" cholesterol increased by 14.6%. HDL cholesterol is called "good" cholesterol because it helps remove the "bad" cholesterol from the blood. The average cholesterol levels for this group were 242 mg/dL; average LDL was 158 mg/dL and the average HDL was 50mg/dL.

"In China, the red yeast is known to promote healthy heart function," says Rippe.

He speculated that the differences in results between the Chinese and Boston studies could be due to the fact the Chinese study used more concentrated yeast than found in Cholestin.

"As a natural substance there are hundreds of potentially active ingredients in Cholestin that could have contributed to the cholesterol lowering. Cholestin contains a range of HMG-CoA reductase inhibitors that probably contribute to the effect," Rippe says. "The Chinese study participants received approximately 13.5 milligrams of HMG-CoA reductase inhibitors each day in the Cholestin preparation that they took, while the participants in Boston received about 9.6 mg per day," according to Rippe.

Most of the cholesterol that circulates in the blood does not come from dietary cholesterol but is instead manufactured by the liver. HMG-CoA reductase is an enzyme found in the liver that controls cholesterol production in the body. By inhibiting that enzyme, red yeast reduces the body's cholesterol output, according to Rippe.

"Although red yeast fermented on rice is used to spice traditional Chinese food, such as Peking duck and spareribs, this is not an effective way to consume the substance," says Rippe. "The capsule form of red yeast rice contains a more consistent amount of the active ingredients than the amount people in China obtain from these sources in their diet.

The American Heart Association continues to advise individuals to try to lower high blood cholesterol with a diet that is low in saturated fat and rich in fruit, vegetables and whole grain.

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