Abstract - red yeast rice
Red Yeast Rice is a unique natural product native to China that's been used in Asian traditional medical
systems since approximately 800 A.D. It is produced by the fermentation of red yeast (Monascus
purpureus) with white rice. However, manufacturers need to carefully produce the product to avoid the
presence of citrinin, a toxic by-product of the fermentation process.

Red yeast rice has been shown to have the benefits of
cholesterol-lowering activities, as it contains
lovastatin (a HMG-CoA reductase inhibitor which inhibits cholesterol synthesis in the body) as well as
other cholesterol-lowering compounds. [2] Red yeast rice is likely to be able to directly impact the
process of atherosclerosis consequently, it may carry the benefits of cardiovascular diseases. [3]

Red yeast rice benefit - animal studies
Researchers have studied the tong-term effects of red yeast rice extract on serum lipids and severity of
atherosclerosis in rabbits. In the study, the researchers fed the rabbit with the extract together with
0.25% cholesterol for 200 days. They found 25% and 40% reductions in total cholesterol with respect to
doses of 0.4 and 1.35 g/kg/day of the red yeast rice. They also observed a reduction of serum LDL
cholesterol, triglycerides and atherosclerotic index. [7]

Red yeast rice benefit - clinical studies
There are a few clinical studies about the beneficial effect of red yeast rice on cholesterol levels. Most of
the subjects are either patients suffered from hyperlipidermia or coronary artery disease. All studies
reviewed show the efficacy of red yeast rice on cholesterol-lowering. To simplify this report, I
summarized the results of the "most recent studies".

A recent clinical study has demonstrated that ingestion of a red yeast rice extract (Xuezhikang) led to
rapid reduction of C-reactive protein levels within 24 h and lipid profile within 2 weeks. In the study, they
randomly assigned 48 consecutive patients with stable angina to 1200 or 2400 mg/day of a red yeast
rice extract (Xuezhikang). They found that the red yeast rice extract Xuezhikang reduced total
cholesterol, low-density lipoprotein (LDL) cholesterol, median plasma C-reactive protein levels and in
mean plasma C-reactive protein levels significantly. AThe higher dose of the red yeast rice extract
Xuezhikang (2400 mg/day) resulted in significantly greater reductions in total cholesterol TC and
low-density lipoprotein LDL cholesterol compared with 1200 mg/day group (p<0.05, p<0.01,
respectively. While, they observed a less reduction in triglycerides (TG) levels and no significant
difference in mean high-density lipoprotein (HDL) cholesterol levels compared with baseline. [5]

In another study of patients with coronary heart disease at dose of 1200 mg/d for 6 weeks, researchers
also observed the reduction of lipid levels and improvement of inflammation after the administration of
the red yeast rice extracts. [8]

Hyperlipidemia is a well-known risk factor for atherosclerosis and statins are widely used to treat patients
with elevated levels of lipids in their plasma. Notwithstanding the proven benefits of statin drugs on both
primary and secondary prevention of heart disease, the high cost of statin treatment, in addition to
possible side effects such as liver function abnormalities, may limit their widespread use. We conducted
a study on a natural product as an alternative to statin treatment. Cholestin, a dietary supplement, is
prepared from rice fermented with red yeast (Monascus purpureus), which has been shown to
significantly decrease total cholesterol levels in hyperlipidemic subjects. Our objective was to determine
the cellular effect of Cholestin on cholesterol synthesis in human hepatic cells (HepG2) and the
mechanism by which it caused a change in lipid metabolism.

A red yeast extract was found to have a direct inhibitory effect on HMG-CoA reductase activity (78-69%
of control). In the study, researchers found this red yeast extract (25-100 microg/mL) were significantly
reduced cholesterol levels in human hepatic cells HepG2in a dose-dependent manner (81-45% of
control, respectively). They found and association of this reduction with the decreased synthesis and
secretion of both unesterified cholesterol (54-31 and 33-14% of control, respectively) and cholesteryl
ester (18-6 and 37-19% of control, respectively). Thus, one of the anti-hyperlipidemic actions of the red
yeast rice in the study was a consequence of an inhibitory effect on cholesterol biosynthesis in hepatic
cells. [9]

A recent study of 62 people who stopped taking statins because of side effects reported a significant
cholesterol-lowering effect of a commercially available nonprescription red yeast rice product. The
average drop in cholesterol was 43 points at 12 weeks. The participants took three 600-milligram vials
of red yeast rice twice a day. Each vial had only one milligram of lovastatin, so they took about 6 mg a
day. The participants also followed a lifestyle change program, including education on nutrition, exercise
and relaxation techniques. [AA1]

In fact, a year ago, somebody has already reported that supplements of
fish oil and red yeast rice,
coupled with lifestyle changes in diet and exercise habits, can reduce cholesterol as much as standard
cholesterol- lowering medications known as statins, according to a new study. [AA2]

The equivalent dose of lovastatin is 6 mg a day. The lowest strength of Mevacor (lovastatin tablet) is 20
mg, but the prescription does not request patients to follow a restrictive lifestyle plan. I wonder if a
patient takes only 6 mg of Mevacor and follows that lifestyle plan, will this combined therapy also allow a
significant cholesterol-lowering effect, with a minimal side effects? It is a common sense that the severity
of side effect is proportional to the dose. Anyway, exercise, a balanced diet with supplements, rest,
sleep and peaceful environment are important to our health.

Red yeast rice side effect can be serious. Researchers from Catholic University of Rome reported that a
sixty-three year old woman presented with severe hypertransaminasemia. For six months she had been
taking Equisterol, an over-the-counter lipid-lowering product containing guggulsterol and red yeast rice
extract. After she stopped to take Equisterol, her liver functions returned to normal. [AA3]

Red yeast rice side effect is dose-proportional. Researchers from Taipei Medical University evaluated
the effect of high doses of red yeast rice on coenzyme Q10 (CoQ10) levels in the tissues of 85 ICR
mice. They found that CoQ10 levels in liver and heart declined dramatically 30 minutes after the
ingestion of red yeast rice. And, the effect persists for 24 hours and it is dose proportional. [4]

Red yeast rice side effect may be related to its lovastatin content. A case of red yeast rice side effects
was reported by researchers at James H. Quillen College of Medicine, East Tennessee State University.
A middle-aged man presented with joint pain and muscle weakness that had begun 2 months before
presentation. Three months before presentation, he had begun to take a herbal preparation of red rice.
Laboratory testing revealed a moderately elevated creatine phosphokinase level. Symptoms and
laboratory abnormalities resolved with discontinuation of the red rice. Eight months later, he resumed
the product and his creatine phosphokinase level rose again. The researchers believed that the active
ingredient, i.e. lovastatin, in the red rice was the cause of his myopathy.. [6]

Because the active ingredient of red yeast rice is lovastatin, theorically the side effects of red yeast rice
should be similar to the side effect of the prescription lovastatin (i.e. Mevacor). Rhabdomyolysis is a
known complication of hepatic 3-methylglutaryl coenzyme A reductase (HMG-CoA) inhibitor (statin)
therapy for post-transplant hyperlipidemia, and thus monitoring for this effect is indicated. Researchers
from University of Toronto reported a case of an herbal preparation-induced rhabdomyolysis in a stable
renal-transplant recipient, attributed to the presence of red yeast rice (Monascus purpureus) within the
mixture. The condition resolved when consumption of the product ceased. [AA4]

As discussed before, one of the red yeast rice side effects is alternation of the CoQ10 level. Thus,
manufacturers market red yeast rice product containing CoQ10 to support healthy cardiovascular and
immune system function.

Reference [1] Herbs for serum cholesterol reduction: a systematic view. J Fam Pract. 2003 Jun;52(6):468-78. [2] Patrick
L and Uzick M Cardiovascular disease: C-reactive protein and the inflammatory disease paradigm: HMG-CoA reductase
inhibitors, alpha-tocopherol, red yeast rice, and olive oil polyphenols. A review of the literature. Altern Med Rev. 2001
Jun;6(3):248-71. [3] Herbs and atherosclerosis. Curr Atheroscler Rep. 2001 Jan;3(1):93-6. [4] Yang HT et al, Acute
administration of red yeast rice (Monascus purpureus) depletes tissue coenzyme Q(10) levels in ICR mice. Br J Nutr.
2005 Jan;93(1):131-5. [5] Li JJ et al, Effects of xuezhikang, an extract of cholestin, on lipid profile and C-reactive protein: a
short-term time course study in patients with stable angina. Clin Chim Acta. 2005 Feb;352(1-2):217-24. [6] Smith DJ and
Olive KE Chinese red rice-induced myopathy. South Med J. 2003 Dec;96(12):1265-7. [7] Wei W et al, Hypolipidemic and
anti-atherogenic effects of long-term Cholestin (Monascus purpureus-fermented rice, red yeast rice) in cholesterol fed
rabbits. J Nutr Biochem. 2003 Jun;14(6):314-8. [8] Zhao SP et al, Xuezhikang, an extract of cholestin, protects endothelial
function through antiinflammatory and lipid-lowering mechanisms in patients with coronary heart disease. Circulation.
2004 Aug 24;110(8):915-20. Epub 2004 Aug 16. [9] Man RY et al, Cholestin inhibits cholesterol synthesis and secretion
in hepatic cells (HepG2). Mol Cell Biochem. 2002 Apr;233(1-2):153-8. [AA1] A Substitute for Those Who Can't Take
Statins? HealthDay Mon Jun 15, 2009 [AA2] Fish Oil, Red Yeast Rice Cut Cholesterol WebMed July 23, 2008 [AA3] Grieco
A, Miele L, Pompili M, Biolato M, Vecchio FM, Grattagliano I, Gasbarrini G.Acute hepatitis caused by a natural
lipid-lowering product: when "alternative" medicine is no "alternative" at all J Hepatol. 2009 Jun;50(6):1273-7. Epub 2009
Mar 31 [AA4] Prasad GV, Wong T, Meliton G, Bhaloo S. Rhabdomyolysis due to red yeast rice (Monascus purpureus) in a
renal transplant recipient.Transplantation. 2002 Oct 27;74(8):1200-1
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