The medication is sold under the brand name Avodart.
A previous study had found that a similar drug, finasteride, could also lower the risk of prostate tumors, but the new research – conducted at 250 sites in 42 countries – suggests that dutasteride is slightly more effective.
The new study “is further evidence that there is a role for these drugs in risk reduction,” said Dr. Jack Jacoub, a medical oncologist at Orange Coast Memorial Medical Center in Fountain Valley, Calif., who was not involved in the study. “If a patient understands all the issues [associated with the drug], I think it would be appropriate to provide it.”
Dr. Howard M. Sandler, an oncologist at the Cedars-Sinai Medical Center in Los Angeles, was even more emphatic.
“The question might be, why isn’t every man taking one of these drugs?” he said. “They help people urinate better by shrinking the prostate, they probably reduce baldness, and they reduce the risk of prostate cancer. There seems to be very little downside to them.”
GlaxoSmithKline, which manufactures Avodart, said on Monday that it would apply to the Food and Drug Administration for permission to market the drug for risk reduction in men with high PSA levels, a measure of prostate cancer risk; a family history of the disease, or other risk factors such as ethnicity.
But because the drug is already available, doctors do not need to wait for such permission to prescribe it as a preventive.
Considering the low risk of the drug, that might be a safe option, experts said. Insurance companies are not likely to pay for it for that purpose, however, until the FDA approves it.
Latin name: Monascus purpureus Other names: Hong Qu, red rice, red yeast Synonyms:
Alkaloids, angkak, anka, ankaflavin, Asian traditional fermentation foodstuff, astaxanthin, beni-koju, ben-koji, Chinese red yeast rice, citrinin, CRYR, dehydromonacolin K, dietary red yeast, dihydromeyinolin, dihydromonacolin K, dihydromonacolin L, DSM1379, DSM1603, ergosterol, flavonoids, GABA, glycosides, HMG-CoA reductase inhibitors, hon-chi, hong qu, hongqu, hung-chu, hydroxymethylglutaryl coenzyme A reductase, KCCM11832, koji, linoleic acid, lovastatin, M9011, mevinolin, monacolin hyroxyacid, monacolin J, monacolin K, monacolin K (hydroxyl acid form), monacolin L, monacolin M, monacolin X, Monascaceae (yeast family), monascopyridine A, monascopyridine B, monascopyridine C, monascopyridine D, monascorubramine, monascorubrin, Monascus , Monascus anka , Monascus purpureus fermentate, Monascus purpureus HM105, Monascus purpureus NTU568, Monascus purpureus Went rice, Monascus ruber , oleic acid, orange anka pigment, palmitoleic acid, Phaffia rhodozyma , red fermented rice, red koji, red leaven, red mould rice, red rice, red rice yeast, red yeast, red yeast rice extract, rice, RICE products, rubropunctamine, rubropunctatin, RYR, RYRE, saponins, statins, stearic acid, xuezhikang, Xue Zhi Kang, yellow anka pigment, zhitai, Zhi Tai.
Red yeast rice, red fermented rice, red kojic rice, red koji rice, or ang-kak, is a bright reddish purple fermented rice, which acquires its colour from being cultivated with the mold Monascus purpureus. In Japan, it is known as beni-koji ( lit. “red koji”) or akakoji ( also meaning “red koji”) and in Taiwan it is sometimes also called âng-chau , in Taiwanese. Among the Hakka, it is known as fungkiuk. In China it is widely available under the brand name XueZhiKang, and in Singapore it is available as Hypocol.
Red yeast rice is sold in jars at Asian markets as a pasteurized wet aggregate, whole dried grains, or as a ground powder. It was a commonly used red food colouring in East Asian and Chinese cuisine prior to the discovery of chemical food colouring. It has also been used in Chinese herbal medicine.
Red yeast rice is the product of yeast ( Monascus purpureus ) grown on rice, and is served as a dietary staple in some Asian countries. It contains several compounds collectively known as monacolins, substances known to inhibit cholesterol synthesis. One of these, “monacolin K,” is a potent inhibitor of HMG-CoA reductase, and is also known as mevinolin or lovastatin (Mevacor®, a drug produced by Merck & Co., Inc).
Red yeast rice extract has been sold as a natural cholesterol-lowering agent in over the counter supplements, such as CholestinTM (Pharmanex, Inc). However, there has been legal and industrial dispute as to whether red yeast rice is a drug or a dietary supplement, involving the manufacturer, the U.S. Food and Drug Administration (FDA), and the pharmaceutical industry (particularly producers of HMG-CoA reductase inhibitor prescription drugs or “statins”).
The use of red yeast rice in China was first documented in the Tang Dynasty in 800 A.D. A detailed description of its manufacture is found in the ancient Chinese pharmacopoeia, Ben Cao Gang Mu-Dan Shi Bu Yi, published during the Ming Dynasty (1368-1644). In this text, red yeast rice is proposed to be a mild aid for gastric problems (indigestion, diarrhea), blood circulation, and spleen and stomach health. Red yeast rice in a dried, powdered form is called Zhi Tai. When extracted with alcohol it is called Xue Zhi Kang.
Red yeast rice has been used in China as a preservative, spice, and food coloring. It’s used to give Peking duck its characteristic red color and can also be an ingredient in fish sauce, fish paste, and rice wine. Red yeast rice is used in traditional Chinese medicine as a remedy for poor circulation, indigestion, and diarrhea.
Red yeast rice contains naturally-occurring substances called monacolins. Monocolins, particularly one called lovastatin, is believed to be converted in the body to a substance that inhibits HMG-CoA reductase, an enzyme that triggers cholesterol production. This is the way the popular statin drugs work.
Because of this action, red yeast rice products containing a higher concentration of monocolins have been developed and marketed as a natural product to lower cholesterol.
The problem is that the primary ingredient in these supplements, lovastatin, is also the active pharmaceutical ingredient in prescription drugs for high cholesterol such as Mevacor. In fact, lovastatin was originally derived from another type of red yeast called Monascus ruber.
Red yeast rice is produced by cultivating Monascus purpureus on polished 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 steamed for the purpose of sterilizing and cooking the grains prior to inoculation. Inoculation is done by mixing M. purpureus spores or powdered red yeast rice together with the processed rice. 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.
Due to the high cost of chemical dyes, some producers of red yeast rice have tried to adulterate their products with red dye #2 Sudan Red G (in Chinese).
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.
Although used mainly for its colour in cuisine, red yeast rice imparts a subtle but pleasant taste to food.
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. and taken internally to invigorate the body, aid in digestion, and remove “blood blockages”.
Red yeast rice when produced using the ‘Went’ strain of Monascus purpureus contains significant quantites of the HMG-CoA reductase inhibitor lovastatin which is also known as mevinolin, a naturally-occurring statin. It is sold as an over the counter dietary supplement for controlling cholesterol (See ref.: Medicine Net). There is strong scientific evidence for its effect in lowering blood levels of total cholesterol, low-density lipoprotein/LDL (“bad cholesterol”), and triglyceride levels (see below). Because an approved drug is identical to the molecule it is therefore regulated as a drug by the Food and Drug Administration (FDA).
In 1998, the U.S. district court in Utah allowed a product containing red yeast rice extract known as Cholestin to be sold without restriction, but this was reversed on appeal. (Moore, 2001) (see ref.: PDRhealth). Cholestin as a product continues to be marketed but no longer contains red yeast rice (RYR). Other companies sell red yeast rice products but most of them use a different strain of yeast or different growing conditions, resulting in RYR with a negligible statin content. The labeling on these new products often says nothing about cholesterol lowering. As late as August 2007, FDA noted supplements being sold containing significant lovastatin levels.(FDA, 2007)
In 2006 Liu et al published a meta-analysis of clinical trials (Chinese Med 2006;1:4-17). 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. Zhao et al reported on a four-year trial in people with diabetes (J Cardio Pharmacol 2007;49:81-84). There was a 40-50% reduction in cardio events and cardio deaths in the treated group. Ye et al reported on a four-year trial in elderly Chinese patients with heart disease (J Am Geriatr Soc 2007;55:1015-22). Deaths were down 32%. There is at least one report in the literature of a statin-like myopathy caused by red yeast rice (Mueller PS. Ann Intern Med 2006;145:474-5).
An article in the June 15, 2008, issue of the American Journal of Cardiology found that red yeast rice may provide benefits beyond those provided by statins. The researchers reported that the benefits seemed to exceed those reported with lovastatin alone.
ConsumerLab.com found large variation in the active compounds between red yeast rice supplements, and also found that some of them were contaminated with citrinin, a nephrotoxic mycotoxin. Evidence about the side effects of red yeast rice is limited, but it may have similar side effects to the drug lovastatin, which include kidney problems and other side effects. Regular medical monitoring is needed to detect such effects.
These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.
Uses based on scientific evidence :-
Since the 1970s, human studies have reported that red yeast lowers blood levels of total cholesterol, low-density lipoprotein/LDL (“bad cholesterol”), and triglyceride levels. Other products containing red yeast rice extract can still be purchased, mostly over the Internet. However, these products may not be standardized and effects are not predictable. For lowering cholesterol, there is better evidence for using prescription drugs such as lovastatin…..GRADE: A
Coronary heart disease
Preliminary evidence shows that taking Monascus purpureus by mouth may result in cardiovascular benefits and improve blood flow. Additional study is needed before a firm recommendation can be made…GRADE: C
Early human evidence suggests the potential for benefits in diabetics. Additional study is needed before a firm recommendation can be made….GRADE C
Key to grades :- A: Strong scientific evidence for this use;
B: Good scientific evidence for this use;
C: Unclear scientific evidence for this use;
D: Fair scientific evidence against this use;
F: Strong scientific evidence against this use.
Red yeast rice is classified as a dietary supplement by the FDA. Because of its similarity to the statin drugs, there is an ongoing legal debate about whether red yeast rice should be reclassified as a prescription drug rather than a dietary supplement.
Uses based on tradition or theory :-
The below uses are based on tradition or scientific theories. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.
The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.
Adults (18 years and older)
1,200 milligrams of concentrated red yeast powder capsules have been taken two times per day by mouth with food.
The average consumption of naturally occurring red yeast rice in Asia has been reported as 14-55 grams per day.
Children (younger than 18 years)
There is not enough scientific evidence to recommend red yeast for children.
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.
There is one report of anaphylaxis (a severe allergic reaction) in a butcher who touched meat containing red yeast.
Side Effects and Warnings:-
There is limited evidence on the side effects of red yeast. Mild headache and abdominal discomfort can occur. Side effects may be similar to those for the prescription drug lovastatin (Mevacor®). Heartburn, gas, bloating, muscle pain or damage, dizziness, asthma, and kidney problems are possible. People with liver disease should not use red yeast products.
In theory, red yeast may increase the risk of bleeding. Caution is advised in patients with bleeding disorders or taking drugs that may increase the risk of bleeding. Dosing adjustments may be necessary. A metabolite of Monascus called mycotoxin citrinin may be harmful.
Pregnancy and Breastfeeding
Prescription drugs with similar chemicals as red yeast cannot be used during pregnancy. Therefore, it is recommended that pregnant or breastfeeding women not take red yeast.
Most herbs and supplements have not been thoroughly tested for interactions with other herbs, supplements, drugs, or foods. The interactions listed below are based on reports in scientific publications, laboratory experiments, or traditional use. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy.
Interactions with Drugs
There are not many studies of the interactions of red yeast rice extract with drugs. However, because red yeast rice extract contains the same chemicals as the prescription drug lovastatin, the interactions may be the same. Fibrate drugs or other cholesterol-lowering medications may cause additive effects or side effects when taken with red yeast. Alcohol and other drugs that may be toxic to the liver should be avoided with red yeast rice extract. Taking cyclosporine, ranitidine (Zantac®), and certain antibiotics with red yeast rice extract may increase the risk of muscle breakdown or kidney damage.
Certain drugs may interfere with the way the body processes red yeast using the liver’s “cytochrome P450” enzyme system. Inhibitors of cytochrome P450 may increase the chance of muscle and kidney damage if taken with red yeast.
In theory, red yeast may increase the risk of bleeding when taken with drugs that increase the risk of bleeding. Some examples include aspirin, anticoagulants (“blood thinners”) such as warfarin (Coumadin®) or heparin, anti-platelet drugs such as clopidogrel (Plavix®), and non-steroidal anti-inflammatory drugs such as ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®).
Red yeast may produce gamma-aminobutyric acid (GABA) and therefore can have additive effects when taken with drugs that affect GABA such as neurontin (Gabapentin®).
Red yeast may also interact with digoxin, niacin, thyroid medications, and blood pressure-lowering medications. Caution is advised.
Red yeast may alter blood sugar levels; patients with diabetes or taking insulin or blood sugar-lowering medications by mouth should consult with a qualified healthcare professional, including a pharmacist. Dosing adjustments may be necessary.
Interactions with Herbs and Dietary Supplements
Red yeast may interact with products that cause liver damage or are broken down in the liver. Grapefruit juice may increase blood levels of red yeast. Milk thistle, St. John’s wort, niacin, and vitamin A may interact with red yeast rice extract. Coenzyme Q10 levels may be lowered by red yeast rice extract. Cholesterol-lowering herbs and supplements such as guggul or fish oils may have increased effects when taken with red rice yeast. Although not well studied, red yeast may also interact with astaxanthin and zinc. Caution is advised.
Certain herbs and supplements may interfere with the way the body processes red yeast using the liver’s “cytochrome P450” enzyme system. Inhibitors of cytochrome P450 may increase the chance of muscle and kidney damage if taken with red yeast.
In theory, red yeast may increase the risk of bleeding when taken with herbs and supplements that are believed to increase the risk of bleeding. Multiple cases of bleeding have been reported with the use of Ginkgo biloba , and fewer cases with garlic and saw palmetto. Numerous other agents may theoretically increase the risk of bleeding, although this has not been proven in most cases.
Red yeast may also interact with digitalis (foxglove), or herbs and supplements that affect the thyroid or blood pressure. It may also have anti-inflammatory effects and should be used cautiously with other herbs or supplements that may have anti-inflammatory effects.
Red yeast may alter blood sugar levels in the blood, and patients with diabetes or taking herbs and supplement to control blood sugar should use with caution.
Disclaimer:The information presented herein is intended for educational purposes only. Individual results may vary, and before using any supplements, it is always advisable to consult with your own health care provider.
A marine compound discovered off the coast of Key Largo in Florida inhibits cancer cell growth in lab tests and is likely to prompt the development of effective new drugs.
The University of Florida (UF)-patented compound, largazole, is derived from cyanobacteria that grow on coral reefs. It is being described as one of the most promising finds since the college’s marine lab was established three years ago.
The molecule’s natural chemical structure and its ability to inhibit cancer cell growth were first described in the Journal of American Chemical Society in February, and the lab synthesis and description of the molecular basis for its anti-cancer activity appeared on July 2.
“It’s exciting because we’ve found a compound in nature that may one day surpass a currently marketed drug or could become the structural template for rationally designed drugs with improved selectivity,” said Hendrik Luesch, assistant professor in UF’s Department of Medicinal Chemistry and the study’s principal investigator.
Largazole, discovered and named by Luesch for its Florida location and structural features, seeks out a family of enzymes called histone deacetylase, or HDAC. Overactivity of certain HDACs has been associated with several cancers such as prostate and colon tumours, and inhibition of HDACs can activate tumour-suppressor genes that have been silenced in these cancers.
Although scientists have been probing the depths of the ocean for marine products since the early 1960s, many pharmaceutical companies lost interest before researchers could deliver useful compounds because natural products were considered too costly and time-consuming to research and develop.
Many common medications, from pain relievers to cholesterol-reducing statins, stem from natural products that grow on the earth, but there is literally an ocean of compounds yet to be discovered in our seas.
Only 14 natural marine products developed are in clinical trials today, Luesch said, and one drug recently approved in Europe is the first-ever marine-derived anti-cancer agent.
“Marine study is in its infancy”, said William Fenical, professor of oceanography and pharmaceutical sciences at the University of California, San Diego. “The ocean is a genetically distinct environment and the single, most diverse source of new molecules to be discovered”.
HDACs are already targeted by a drug approved for cutaneous T-cell lymphoma manufactured by the global pharmaceutical companyMerck & Co. Inc. However, UF’s compound does not inhibit all HDACs equally, meaning a largazole-based drug might result in improved therapies and fewer side effects, Luesch said.
Luesch said that, within the next few months, he plans to study whether largazole reduces or prevents tumour growth in mice. Luesch has several other anti-tumour natural products from Atlantic and Pacific cyanobacteria in the pipeline.
These results were presented on Thursday at an international natural products scientific meeting in Athens.
Flu shots for elementary school children can help reduce flu like illness in the whole family, finds new research published in the New England Journal of Medicine this week. Doctors compared families and schools where, in some cases, the elementary school-age kids were offered free flu vaccination. Adults in the families of the vaccinated kids had fewer bouts of flu like illness, and they missed less work due to sickness in either themselves or their children. Elementary-age and high school age children were absent from school less frequently in families where at least one child was vaccinated. Researchers say that vaccinated kids are less likely to catch the flu and bring it home, thus offering “whole herd” protection to people around them.