Red yeast rice

Dried grain red yeast rice

Red yeast rice (simplified Chinese: 红曲米; traditional Chinese: 紅麴米; pinyin: hóng qū mǐ; literally: "red yeast rice"), red rice koji (べにこうじ, lit. 'red koji'), 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 what is referred to as a "koji" in Japanese, meaning "grain or bean overgrown with a mold culture", a food preparation tradition going back to ca. 300 BC.[1] In both the scientific and popular literature in English that draws principally on Japanese, red yeast rice is most often referred to as "red rice koji".[1] English works favoring Chinese sources may prefer the translation "red yeast rice".

Because of the low cost of chemical dyes, some producers of red yeast rice have adulterated their products with the poisonous dye Sudan Red G.[2]

Production

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.

Uses

Culinary

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 huangjiu (Shaoxing jiu), and Japanese sake (akaisake), imparting a reddish colour to these wines.[3] 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 province of China.

Traditional Chinese medicine

In addition to its culinary use, red yeast rice is also used in Chinese herbology and traditional Chinese medicine. Its use has been documented as far back as the Tang Dynasty in China in 800 AD. It is taken internally to invigorate the body, aid in digestion, and revitalize the blood.[4] 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 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 fungus used to make red yeast rice but cultured under carefully controlled conditions. Chemical analysis soon showed that lovastatin and monacolin K are identical. The article "The origin of statins" summarizes how the two isolations, documentations and patent applications were just months apart.[5] 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 trials of ≥12 weeks duration, totaling 68,485 participants, LDL-cholesterol was lowered by 24-49% depending on the statin.[6] Different strains of Monascus fungus will produce different amounts of monacolins. The 'Went' strain of Monascus purpureus (purpureus = dark red 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.[7]

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. Court of Appeals. (Moore, 2001) (see Further Reading: PDRhealth). 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. 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.[8][9] The FDA also issued a warning press release. 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.[10]

In 2008, 2014, and 2018, ConsumerLab.com published laboratory tests of red yeast rice supplements purchased from US retailers, most recently stating "the suggested daily servings of only two products provided the amount of lovastatin compounds shown to lower cholesterol levels." The ConsumerLab.com reports include results by brand.[11][12] A 2017 study from the European Journal of Preventive Cardiology (EJPC) tested 28 brands of red yeast rice supplements purchased from US retailers, stating "the quantity of monacolin K varied from none to prescription strength [...]" This European study did not list the individual brands, but only the results.[13]

As of 2016, 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.[14][15]

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/day). A meta-analysis of 20 clinical trials, range of red yeast rice dose 1200 to 4800 mg/day, reported LDL-cholesterol lowered by 1.02 mmol/L (39.4 mg/dL) compared to placebo. The incidence of reported adverse effects ranged from 0% to 5% and was not different from controls.[16]

Within this review, the largest and longest duration trial was conducted in China: the China Coronary Secondary Prevention Study (CCSPS). Close to 5,000 post-heart attack patients were enrolled for an average of 4.5 years to receive either a placebo or a RYR product named Xuezhikang (血脂康). The test product was an ethanol extract of red yeast rice, with a monacolin K content of 11.6 mg/day. 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%.[17]

The CCSPS heart attack and cardiovascular death outcomes appear to be better than what has been reported for prescription statin 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 might have been more effectively athero-protective than expected in the Chinese population in the CCSPS study for the same reason.[18]

Safety

The safety of red yeast rice products has not been established, and some commercial supplements have been found to contain high levels of the toxin citrinin.[19] As commercial products will have highly variable amounts of monacolins,[19] 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. As evidence, one published analysis reported several commercial products as being almost entirely monacolin K - which would occur if the drug lovastatin was added - rather than the expected composition of many monacolin compounds.[14] 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 reports in the literature of muscle myopathy and liver damage resulting from red yeast rice usage.[20] 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 were administered 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 having completed the trial, subjective muscle pain scores were similar for the two groups.[21] "The potential safety signals of myopathies and liver injury raise the hypothesis that the safety profile of RYR is similar to that of statins. Continuous monitoring of dietary supplements should be promoted to finally characterize their risk profile, thus supporting regulatory bodies for appropriate actions."[22]

Red yeast is likely unsafe during pregnancy. It has caused birth defects in animals, and there is not enough information about the safety of using red yeast during breast-feeding.[23]

See also

References

  1. 1 2 Shurtleff, W.; Aoyagi, A. 2012. History of Koji - Grains and/or Beans Overgrown with a Mold Culture (300 BCE to 2012). Lafayette, California: Soyinfo Center. (With 1,560 references and 142 photos and illustrations)
  2. ↑ "福建"红曲粉"酒被疑含苏丹红 相应酒厂遭查封", 东南快报, 2005-04-14 (in Chinese).
  3. ↑ http://www.esake.com/Knowledge/Newsletter/JT/JT2001/jt2001_23.html
  4. ↑ Erdogrull O, Azirak S. (2004). "Review of the studies on the red yeast rice (Monascus purpureus)". Turkish Electronic J Biotech. 2: 37-49.
  5. ↑ 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.
  6. ↑ 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. PMC 317299. PMID 14969594.
  7. ↑ 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.
  8. ↑ http://www.fda.gov/foi/warning_letters/s6455c.pdf
  9. ↑ http://www.fda.gov/foi/warning_letters/s6456c.pdf
  10. ↑ FDA (August 9, 2007). "FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol". Archived from the original on Jan 11, 2017.
  11. ↑ "Red Yeast Rice Supplement Reviews and Information". ConsumerLab.com. Retrieved 2018-10-08.
  12. ↑ Gordon, Ram Y.; Cooperman, Tod; Obermeyer, William; Becker, David J. (2010-10-25). "Marked Variability of Monacolin Levels in Commercial Red Yeast Rice Products". Archives of Internal Medicine. 170 (19). doi:10.1001/archinternmed.2010.382. ISSN 0003-9926.
  13. ↑ Cohen, Pieter; Avula, Bharathi; Khan, Ikhlas (2017-06-23). "Variability in strength of red yeast rice supplements purchased from mainstream retailers". European Journal of Preventive Cardiology. 24 (13): 1431–1434. doi:10.1177/2047487317715714. ISSN 2047-4873.
  14. 1 2 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.
  15. ↑ 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.
  16. ↑ Gerards MC, Terlou RJ, Yu H, Koks CH, Gerdes VE (2015). "Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction but safety is uncertain - a systematic review and meta-analysis". Atherosclerosis. 240 (2): 415–23. doi:10.1016/j.atherosclerosis.2015.04.004. PMID 25897793.
  17. ↑ Lu ZL; Collaborative Group for China Coronary Secondary Prevention Using Xuezhikang (February 2005). "[China coronary secondary prevention study (CCSPS)]". Zhonghua Xin Xue Guan Bing Za Zhi (in Chinese). 33 (2): 109–115. PMID 15924803.
  18. ↑ 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): 1588–1594. PMID 18982874.
  19. 1 2 Gordon, R. Y.; Cooperman, T.; Obermeyer, W.; Becker, D. J. (2010). "Marked Variability of Monacolin Levels in Commercial Red Yeast Rice Products: Buyer Beware!". Archives of Internal Medicine. 170 (19): 1722–1727. doi:10.1001/archinternmed.2010.382. PMID 20975018.
  20. ↑ Philibert C, Bres V, Jean-Pastor MJ, Guy C, Lebrun-Vignes B, Robin P, Pinzani V, Hillaire-Buys D (2016). "[Red yeast-rice-induced muscular injuries: Analysis of French pharmacovigilance database and literature review]". Thérapie (in French). doi:10.2515/therapie/2015053. PMID 28277227.
  21. ↑ 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. doi:10.7326/0003-4819-150-12-200906160-00006. PMID 19528562.
  22. ↑ Mazzanti G, Paola A, et al. Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance system. Br J Clin Pharmacol. 2017 (in press). PMID 28093797. https://dx.doi.org/10.1111/bcp.13171
  23. ↑ "Medline Plus: Red Yeast monograph". Medline Plus.

Further reading

  • Medicine Net. "Red Yeast Rice". Retrieved February 12, 2006.
  • Moore, US FDA (May 5, 2001). "Untitled correspondence" (PDF). Retrieved February 12, 2006.
  • PDRhealth. "Red Yeast Rice". Archived from the original on November 25, 2005. Retrieved February 12, 2006.
  • MedlinePlus. "Red yeast rice (Monascus purpureus)". Retrieved March 28, 2006.
  • Richard N. Rogoros, M.D. "Non-prescription Cholesterol Lowering". Retrieved August 19, 2006.
  • Dennis Lee, M.D. "Red Yeast Rice and Cholesterol - A Critical Review". 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". Archived from the original on Jan 11, 2017.
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