What is red yeast rice?

Red yeast rice is rice that has been fermented by the red yeast, Monascus purpureus. It has been
used by the Chinese for many centuries as a food preservative, food colorant (it is responsible for
the red color of Peking duck), spice, and an ingredient in rice wine. Red yeast rice continues to
be a dietary staple in China, Japan, and Asian communities in the United States, with an
estimated average consumption of 14 to 55 grams of red yeast rice per day per person.

Red yeast rice also has been used in China for over 1,000 years for medicinal purposes. Red
yeast rice was described in an ancient Chinese list of drugs as useful for improving blood
circulation and for alleviating indigestion and diarrhea.

Recently, red yeast rice has been developed by Chinese and American scientists as a product to
lower blood lipids, including cholesterol and triglycerides.

What is the present status of red yeast rice?

Small scale studies using pharmaceutical-grade red rice yeast have continued to demonstrate
efficacy and safety. However, in the United States it is no longer legal to sell supplements of red
yeast rice that contain more than trace amounts of cholesterol lowering substances. For example,
the active ingredients of red rice yeast have been removed from Cholestin marketed in the United
States. (Hypocol, another product containing red yeast rice is no longer being sold in the United
States.)

The reasons the Food and Drug Administration (FDA) has ruled that it is illegal to sell red yeast
rice that contains more than trace amounts of the cholesterol-lowering substances and to promote
red yeast rice for lowering cholesterol levels.

• First, statin drugs are associated with muscle and kidney injury when used alone or
combined with other medications. There is concern that patients who already take statin
drugs with or without these other medications may increase their risk of muscle or kidney
injury.

• Second, the FDA considers the products containing red yeast rice with high levels of
cholesterol lowering substances to be new, unapproved drugs for which marketing
violates the Federal Food, Drug, and Cosmetic Act.
Data from Wikipaedia as below

Red yeast rice

red fermented rice, red kojic rice, red koji rice, anka, or ang-kak, is a bright
reddish purple fermented rice, which acquires its colour from being cultivated with
the mold Monascus purpureus.

Red yeast rice is produced by cultivating the yeast strain Monascus purpureus on rice. The rice is
first soaked in water until the grains are fully saturated. The raw soaked rice can then either be
directly inoculated or it can be steamed for the purpose of sterilizing and cooking the grains prior
to inoculation. Inoculation is done by mixing either M. purpureus spores or powdered red yeast
rice together with the rice that is being treated. The mix is then incubated in an environment
around room temperature for 3–6 days. During this period of time, the rice should be fully
cultured with M. purpureus, with each rice grain turning bright red in its core and reddish purple
on the outside.

The fully cultured rice is then either sold as the dried grain, or cooked and pasteurized to be sold
as a wet paste, or dried and pulverized to be sold as a fine powder. China is the world's largest
producer of red yeast rice.

Culinary

The dried grain can be prepared and eaten in the same manner as white rice—a common practice
among Asians. It can also be added to other foods.

Red yeast rice is used to colour a wide variety of food products, including pickled tofu, red rice
vinegar, char siu, Peking Duck, and Chinese pastries that require red food colouring. It is also
traditionally used in the production of several types of Chinese wine, Japanese sake (akaisake),
and Korean rice wine (hongju), imparting a reddish colour to these wines.[2] Although used
mainly for its colour in cuisine, red yeast rice imparts a subtle but pleasant taste to food and is
commonly used in the cuisine of Fujian regions of China. The Chinese widely believe that the
wet paste from red yeast rice contains beneficial nutrients for women who have recently given
birth.

Traditional Chinese medicine

In addition to its culinary use, red yeast rice is also used in traditional Chinese herbology and
traditional Chinese medicine. Its use has been documented as far back as the Tang Dynasty in
China in 800 A.D. It is taken internally to invigorate the body, aid in digestion, and revitalize the
blood.[1] A more complete description is in the traditional Chinese pharmacopoeia, Ben Cao
Gang Mu-Dan Shi Bu Yi, from the Ming Dynasty (1378-1644).

Red yeast rice and 'statin' drugs

In the late 1970s, researchers in the United States and Japan were isolating lovastatin from
Aspergillus and monacolins from Monascus, respectively, the latter being the same yeast used to
make red yeast rice but cultured under carefully controlled conditions. Chemical analysis soon
showed that lovastatin and monacolin K were identical. An article "The origin of statins"
summarizes how the two isolations, documentations and patent applications were just months
apart.[2] Lovastatin became the patented, prescription, drug Mevacor for Merck & Co. Red yeast
rice went on to become a contentious, non-prescription, dietary supplement in the United States
and other countries.

Lovastatin and other prescription 'statin' drugs inhibit cholesterol synthesis by blocking action of
the enzyme HMG-CoA reductase. As a consequence circulating total cholesterol and LDL-
cholesterol are lowered. In a meta-analysis of 91 randomized clinical trial of ≥12 weeks duration,
totaling 68,485 participants, LDL-cholesterol was lowered by 24-49% depending on the statin.[3]
Different strains of Monascus yeast will produce different amounts of monacolins. The 'Went'
strain of Monascus purpureus (purpureus = purple in Latin), when properly fermented and
processed, will yield a dried red yeast rice powder that is approximately 0.4% monacolins, of
which roughly half will be monacolin K (identical to lovastatin). Monacolin content of a red
yeast rice product is described in a 2008 clinical trial report.[4]

Regulatory restrictions

The Food and Drug Administration (FDA) position is that red yeast rice products that contain
monacolin K, i.e., lovastatin, are identical to a drug and thus subject to regulation as a drug. In
1998, the FDA initiated action to ban a product (Cholestin) containing red yeast rice extract. The
U.S. district court in Utah allowed the product to be sold without restriction. This decision was
reversed on appeal to the U.S. District Court. (Moore, 2001) (see Further Reading: PDRhealth).
Shortly thereafter the FDA sent Warning Letters to companies selling red yeast rice. The product
disappeared from the market for a few years.

In 2003 red yeast rice products began to reappear in the U.S. market. As of 2010 there are at least
30 brands available. Many of these avoid the FDA restriction by not having any appreciable
monacolin content. Their labels and websites say no more than "fermented according to
traditional Asian methods" or "similar to that used in culinary applications." The labeling on
these products often says nothing about cholesterol. If they do not contain lovastatin, do not
claim to contain lovastatin, and do not make a claim to lower cholesterol they are not subject to
FDA action. Two reviews confirm that the monacolin content of red yeast rice dietary
supplements can vary over a wide range, with some containing negligible monacolins.[5][6] In
2007 the FDA sent Warning Letters to two dietary supplement companies. One was making a
monacolin content claim about its RYR product and the other was not, but the FDA noted that
both products contained monacolins. Both products were withdrawn.[7][8] The FDA also issued a
warning press release (see Further Reading; FDA 2007). The crux of the release was that
consumers should “…not buy or eat red yeast rice products…may contain an unauthorized drug
that could be harmful to health.” The rationale for “…harmful to health…” was that consumers
might not understand that the dangers of monacolin-containing red yeast rice might be the same
as those of prescription statin drugs.
The FDA efforts to control this market have not been entirely effective. As noted above, many
RYR products are sold in the U.S., including store brands at major pharmacy chains. In addition
to the vague label statements quoted above, some labels and websites imply cholesterol-lowering
function by having user warning language similar to prescription statin drugs and by being
combined with coenzyme Q10, a dietary supplement recommended for people who are using a
prescription statin drug. National Business Journal estimated 2008 sales in the U.S. at $20
million dollars (compared to billions for prescription statins). Outside the United States, red
yeast rice products are available in a number of countries. For example, Hypercol is approved for
sale in Singapore, Malaysia, New Zealand, and Norway. Arterin, another dietary supplement, is
sold in Belgium and France. Xuezhikang (血脂康) is sold in China as a prescription drug. The
European Union situation is as follows: Hecht-Pharma GmbH started selling RYR capsules in
Germany in 2002. Sales were banned in December 2002 by the Bezirksregierung Luneburg on
the grounds that this was a medicinal product. After a series of appeals it was ruled on 15
January 2009 that RYR can be sold in the EU. Of note: the court ruled that the definition of a
medicinal product as dictated by Directive 2001/83/EC and amended by Directive 2004/27/EC
does not apply if the product in question has not been scientifically established to have any
function and even if the product in question contains known active substances (in this instance
RYR containing monacolin K at 1.33 to 3.99 mg/day) as long as those substances are not in
sufficient amount to restore, correct or modify physiological functions when used as directed. On
26 January 2010 European Commission (Standing Committee On The Food Chain And Animal
Health, section on General Food Law) had an exchange of view on the consideration of
fermented red yeast rice in food supplement as a novel food. The Committee concluded, that
'fermented red yeast rice' when used in or as food supplement, should not be considered as
subject to the novel food Regulation.

Clinical evidence

The amount typically used in clinical trials is 1200-2400 mg/day of red yeast rice containing
approximately 10 mg total monacolins of which half are monacolin K. This does raise a question
about the function of the other monacolins and non-monacolin compounds in the products, as the
monacolin K content is lower than what is usually considered effective for lovastatin (20-80
mg/dy). In 2006 Liu et al. published a meta-analysis of clinical trials. The article cited 93
published, controlled clinical trials (91 published in Chinese). Total cholesterol decreased by
35 mg/dl, LDL-cholesterol by 28 mg/dl, triglycerides by 35 mg/dl, and HDL-cholesterol
increased by 6 mg/dl. The incidence of reported adverse effects ranged from 1.3% to 36%.[9] Of
the clinical trials reviewed in the meta-analysis, the only study conducted in the United States
reported a 22% reduction of LDL-cholesterol after 12 weeks.[10]

Subsequent to the 2006 meta-analysis there are a number of articles reporting on a massive trial
conducted in China: the China Coronary Secondary Prevention Study (CCSPS). Close to 5000
post-heart attack patients were enrolled for an average of 4.5 years to either receive a placebo or
a RYR product named Xuezhikang (血脂康). This is a patented-process (U.S. patent
#6,046,022), ethanol extract of red yeast rice, with a total monacolins content of approx. 0.8%. It
is also sold as Lipascor. Key CCSPS results: in the treated group risk of subsequent heart attacks
was reduced by 45%, cardio deaths by 31%, and all-cause deaths by 33%. Some of the articles
report on subsets of the population, i.e., just diabetics or just hypertensives.[11][12][13][14][15][16]
These heart attack and cardiovascular death outcomes appear to be better than what has been
reported for prescription drugs. A 2008 review pointed out that the cardioprotective effects of
statins in Japanese populations occur at lower doses than are needed in Western populations, and
theorized that the low amount of monacolins found in Xuezhikang may be more effectively
athero-protective than expected in the Chinese population in the CCSPS study for the same
reason. Others have speculated that phytosterols or unknown substances in Xuezhikang also
contribute to the benefits.[17]

Safety

The safety of red yeast rice products has not been established. As commercial products will have
differing amounts of monacolins, and rarely declare this content on the label, defining risk is
difficult. Ingredient suppliers have also been suspected of "spiking" red yeast rice preparations
with purified lovastatin. One analysis reported several commercial products as being almost
entirely monacolin K rather than the expected composition of many monacolin compounds.[18]
Statin drugs are known to cause muscle and liver damage. Statin-associated rhabdomyolysis can
lead to kidney damage and possibly kidney failure (renal failure). This is why they are
prescription drugs rather than over-the-counter, and with recommendations that the patients'
physicians schedule liver function tests on a regular basis. There are a number of case reports in
the literature of red yeast rice usage resulting in muscle myopathy and liver damage.[19][20][21][22][23]
[24][25]
In 2009 Becker et al reported on a U.S. trial that enrolled 62 patients with known statin-
associated myalgias. Half got a RYR product (3600 mg/day; 13 mg monacolins; 6 mg monacolin
k) for 24 weeks and half a placebo. In the treated group LDL-cholesterol declined 21%. Two
patients dropped out because of myalgia, 1 for diarrhea, and 1 for dizziness. In the placebo group
one dropped out for myalgia. Creatine phosphokinase increased slightly in the treated group
(from 122 to 128 IU/L) versus decreasing with placebo (117 to 101 IU/L) but the shifts were not
statistically significant. For those who completed the trial, subjective muscle pain scores were
similar for the two groups

References

1. ^ Erdogrull O, Azirak S. (2004). "Review of the studies on the red yeast rice
(Monascus purpureus)". Turkish Electronic J Biotech. 2: 37-49.
2. ^ Endo A (October 2004). "The origin of the statins. 2004". Atheroscler Suppl
5 (3): 125–30. doi:10.1016/j.atherosclerosissup.2004.08.033.
PMID 15531285.
3. ^ Edwards JE, Moore RA (December 2003). "Statins in hypercholesterolaemia:
a dose-specific meta-analysis of lipid changes in randomised, double blind
trials". BMC Fam Pract 4: 18. doi:10.1186/1471-2296-4-18. PMID 14969594.
4. ^ Becker DJ, Gordon RY, Morris PB, et al. (July 2008). "Simvastatin vs
therapeutic lifestyle changes and supplements: randomized primary
prevention trial". Mayo Clin. Proc. 83 (7): 758–64. doi:10.4065/83.7.758.
PMID 18613992.
5. ^ Li YG, Zhang F, Wang ZT, Hu ZB (September 2004). "Identification and
chemical profiling of monacolins in red yeast rice using high-performance
liquid chromatography with photodiode array detector and mass
 spectrometry". J Pharm Biomed Anal 35 (5): 1101–12.
doi:10.1016/j.jpba.2004.04.004. PMID 15336357.
6. ^ Heber D, Lembertas A, Lu QY, Bowerman S, Go VL (April 2001). "An
analysis of nine proprietary Chinese red yeast rice dietary supplements:
implications of variability in chemical profile and contents". J Altern
Complement Med 7 (2): 133–9. doi:10.1089/107555301750164181.
PMID 11327519.
7. ^ www.fda.gov/foi/warning_letters/s6455c.pdf
8. ^ www.fda.gov/foi/warning_letters/s6456c.pdf
9. ^ Liu J, Zhang J, Shi Y, Grimsgaard S, Alraek T, Fønnebø V (2006). "Chinese
red yeast rice (Monascus purpureus) for primary hyperlipidemia: a meta-
analysis of randomized controlled trials". Chin Med 1: 4. doi:10.1186/1749-
8546-1-4. PMID 17302963.
10.^ Heber D, Yip I, Ashley JM, Elashoff DA, Elashoff RM, Go VL (February 1999).
"Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary
supplement". Am. J. Clin. Nutr. 69 (2): 231–6. PMID 9989685.
11.^ Lu ZL; Collaborative Group for China Coronary Secondary Prevention Using
Xuezhikang (February 2005). "[China coronary secondary prevention study
(CCSPS)]" (in Chinese). Zhonghua Xin Xue Guan Bing Za Zhi 33 (2): 109–15.
PMID 15924803.
12.^ Zhao SP, Lu ZL, Du BM, et al. (February 2007). "Xuezhikang, an extract of
cholestin, reduces cardiovascular events in type 2 diabetes patients with
coronary heart disease: subgroup analysis of patients with type 2 diabetes
from China coronary secondary prevention study (CCSPS)". J. Cardiovasc.
Pharmacol. 49 (2): 81–4. doi:10.1097/FJC.0b013e31802d3a58.
PMID 17312447.
13.^ Ye P, Lu ZL, Du BM, et al. (July 2007). "Effect of xuezhikang on
cardiovascular events and mortality in elderly patients with a history of
myocardial infarction: a subgroup analysis of elderly subjects from the China
Coronary Secondary Prevention Study". J Am Geriatr Soc 55 (7): 1015–22.
doi:10.1111/j.1532-5415.2007.01230.x. PMID 17608873.
14.^ Lu Z, Kou W, Du B, et al. (June 2008). "Effect of xuezhikang, an extract
from red yeast chinese rice, on coronary events in a chinese population with
previous myocardial infarction". Am. J. Cardiol. 101 (12): 1689–93.
doi:10.1016/j.amjcard.2008.02.056. PMID 18549841.
http://linkinghub.elsevier.com/retrieve/pii/S0002-9149(08)00353-6.
15.^ Ye P, Wu CE, Sheng L, Li H (July 2009). "Potential protective effect of long-
term therapy with Xuezhikang on left ventricular diastolic function in patients
with essential hypertension". J Altern Complement Med 15 (7): 719–25.
doi:10.1089/acm.2008.0599. PMID 19552598.
16.^ Li JJ, Lu ZL, Kou WR, et al. (August 2009). "Beneficial impact of Xuezhikang
on cardiovascular events and mortality in elderly hypertensive patients with
previous myocardial infarction from the China Coronary Secondary
Prevention Study (CCSPS)". J Clin Pharmacol 49 (8): 947–56.
doi:10.1177/0091270009337509. PMID 19602720.
17.^ Ong HT, Cheah JS (August 2008). "Statin alternatives or just placebo: an
objective review of omega-3, red yeast rice and garlic in cardiovascular
therapeutics". Chin. Med. J. 121 (16): 1588–94. PMID 18982874.
18.^ Li YG, Zhang F, Wang ZT, Hu ZB (September 2004). "Identification and
chemical profiling of monacolins in red yeast rice using high-performance
 liquid chromatography with photodiode array detector and mass
spectrometry". J Pharm Biomed Anal 35 (5): 1101–12.
doi:10.1016/j.jpba.2004.04.004. PMID 15336357.
19.^ Prasad GV, Wong T, Meliton G, Bhaloo S (October 2002). "Rhabdomyolysis
due to red yeast rice (Monascus purpureus) in a renal transplant recipient".
Transplantation 74 (8): 1200–1. doi:10.1097/01.TP.0000031950.34040.79.
PMID 12438974.
20.^ Smith DJ, Olive KE (December 2003). "Chinese red rice-induced myopathy".
South. Med. J. 96 (12): 1265–7. doi:10.1097/01.SMJ.0000100117.79718.DC.
PMID 14696880.
21.^ Vercelli L, Mongini T, Olivero N, Rodolico C, Musumeci O, Palmucci L (April
2006). "Chinese red rice depletes muscle coenzyme Q10 and maintains
muscle damage after discontinuation of statin treatment". J Am Geriatr Soc
54 (4): 718–20. doi:10.1111/j.1532-5415.2006.00668_7.x. PMID 16686894.
22.^ Mueller PS (September 2006). "Symptomatic myopathy due to red yeast
rice". Ann. Intern. Med. 145 (6): 474–5. PMID 16983142.
23.^ Lapi F, Gallo E, Bernasconi S, et al. (October 2008). "Myopathies associated
with red yeast rice and liquorice: spontaneous reports from the Italian
Surveillance System of Natural Health Products". Br J Clin Pharmacol 66 (4):
572–4. doi:10.1111/j.1365-2125.2008.03224.x. PMID 18637891.
24.^ Roselle H, Ekatan A, Tzeng J, Sapienza M, Kocher J (October 2008).
"Symptomatic hepatitis associated with the use of herbal red yeast rice".
Ann. Intern. Med. 149 (7): 516–7. PMID 18838736.
25.^ Grieco A, Miele L, Pompili M, et al. (June 2009). "Acute hepatitis caused by
a natural lipid-lowering product: when "alternative" medicine is no
"alternative" at all". J. Hepatol. 50 (6): 1273–7.
doi:10.1016/j.jhep.2009.02.021. PMID 19398239.
26.^ Becker DJ, Gordon RY, Halbert SC, French B, Morris PB, Rader DJ (June
2009). "Red yeast rice for dyslipidemia in statin-intolerant patients: a
randomized trial". Ann. Intern. Med. 150 (12): 830–9, W147–9.
PMID 19528562.

Further reading

• Medicine Net. "Red Yeast Rice".

http://www.medicinenet.com/red_yeast_rice_monascus_purpureus-
oral/article.htm. Retrieved February 12, 2006.
• Moore, US FDA (May 5, 2001). "Untitled correspondence" (PDF).
http://www.fda.gov/ohrms/dockets/dailys/01/Jun01/061101/let0494.pdf.
Retrieved February 12, 2006.
• PDRhealth. "Red Yeast Rice". Archived from the original on November 25,
2005.
http://web.archive.org/web/20051125052833/http://www.pdrhealth.com/drug
_info/nmdrugprofiles/nutsupdrugs/red_0329.shtml. Retrieved February 12,
2006.
• MedlinePlus. "Red yeast rice (Monascus purpureus)".
http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-redyeast.html.
Retrieved March 28, 2006.
• Richard N. Rogoros, M.D.. "Non-prescription Cholesterol Lowering".
http://heartdisease.about.com/cs/cholesterol/a/Nrxcol_rry.htm. Retrieved
August 19, 2006.
• Dennis Lee, M.D.. "Red Yeast Rice and Cholesterol - A Critical Review".
http://www.medicinenet.com/script/main/art.asp?articlekey=14999.
Retrieved August 19, 2006.
• FDA (August 9, 2007). "FDA Warns Consumers to Avoid Red Yeast Rice
Products Promoted on Internet as Treatments for High Cholesterol".
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01678.html. Retrieved August
10, 2007
Red Yeast Rice 600 mg (Vitamin world 6213) สารสกัดจากข้าวแดงหมักยีสต์ 240 Capsules
(พร้อมส่ง)

ชื่อสินค้า : Red Yeast Rice 600 mg (Vitamin world 6213) สารสกัดจากข้าวแดงหมักยีสต์ 240
Capsules (พร้อมส่ง)

รายละเอียด :

ประโยชน์ของ สารสกัดจากเรดยีสต์ไรซ์ (Red Yeast Rice)

 เรดยีสต์ซ์ คือข้าวแดงที่ได้จากการหมักด้วยเชื้ อราโมแนสคัส (Monascus Purpureus) ซึ่งได้ใช้มา
มากกว่าพันปี ในประเทศจีนเพื่อใช้ในการเก็บรักษาอาหาร (Food preservative) และใช้เป็ นสีอาหาร
(Food colorant) ในอุตสาหกรรมอาหาร เช่น ไวน์แดง เต้าห้้ย้ ี มิโซะ สาเก เป็ นต้น ในประเทศจีนได้
ใช้เป็ นยาสมุนไพรจีนโบราณ ที่ ช่วยให้ระบบการไหลเวียนของเลือดในร่างกายดีข้ ึน (Improving
blood circulation) ช่วยในการบรรเทาการย่อยอาหารที่ไม่ดี และท้องเสีย (For alleviating
indigestion and diarrhea) แต่ในปั จจุบัน เรดยีสต์ไรซ์ ได้มีการพัฒนาโดยนั กวิทยาศาสตร์ของจีน
และอเมริกาให้ใช้ในการลดไขมันโคเรสเตอรอล และไตรกลีเซอไรด์ ในหลอดเลือดหัวใจ และหลอด
เลือดต่างๆ ของร่างกาย (Including lower blood lipids, cholesterol and triglycerides)

Cholestin คือเครื่องปรุง ที่ทำามาจากข้าวหมักใน Red Yeast ซึ่งชาวจีนนำามาใส่ในอาหารบางชนิ ด

เช่น เป็ ดปั กกิ่ง ซี่โครงหม้ เพื่อให้มีสีแดง บริษัท Pharmanex ระบุว่า ข้าวมีสารอาหารที่มีคุณ
ประโยชน์ส้งอย่ม
้ ากมาย และการช่วยลดไขมันในเส้นเลือดก็ประโยชน์ท่ีสำาคัญของข้าวอย่างหนึ่ งด้วย

ในการวิจัยล่าสุดพบว่า คนที่มีไขมันในเลือดส้งเมื่อรับประทาน Red Yeast Rice และนำ้ามันปลา

พร้อมๆ กับการปรับพฤติกรรมการรับประทานอาหาร การออกกำาลังกาย และการทำาเทคนิ คผ่อน
คลาย จะช่วยลดไขมันร้าย ในเลือดลงได้ร้อยละ 40 หรือเทียบเท่ากับการรับประทานยาลดไขมัน ช่วย
ลดคอเลสเตอรอล ลงได้

รหัสสินค้า : 000046 วันที่อพ

ั เดท : 03-11-2553 17:42:56

ร้านค้า : VitaRetail ไวต้า รีเทล จำาหน่ายผลิตภัณฑ์ วิตามินอาหารเสริมนำาเข้า จากต่างประเทศ

ราคาพิเศษ ของแท้ คุณภาพแน่นอน

ราคา : 1,800.00 บาท

ลดเหลือ : 1,550.00 บาท
ประหยัด : 250 บาท

ระยะเวลาการขาย : จนกว่าของจะหมด
Red Yeast Rice supplement, 600 mg

Red Yeast Rice extract supplement, side effects, benefit for cholesterol, dosage,
alternative to statin drugs by Ray Sahelian, M.D.