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What is your response to this? Do you have any plans to remove RYR from Cycle Support?
Red Yeast Rice - It’s Storied Past and why you SHOULDN’T use it!
April 29, 2007
Author’s Note: I have summarized the various Red Yeast Rice components from post cycle therapy: A Clinician’s View (ACV) below. I think this is a good summary of my collective thoughts on Red Yeast Rice plus invites you to look at the storied past of compounds like this in making decisions on what to employ when considering support supplementation, whether it be cholesterol-support (as in this instance), or otherwise.
HISTORY & SUGGESTION
post cycle therapy: ACV Part II: “PRIMARY GOAL: HIGH LDL REDUCTION
Red Yeast Rice
The red yeast (Monascus purpureus) fermented on rice has been used in China for its health-promoting effects for over 2000 years. This yeast is the source of a small group of compounds known as monacolins that can lower cholesterol levels by blocking a key enzyme in the liver. In fact, the cholesterol-lowering drug Mevacor, the trade name for the compound lovastatin, also known as monacolin K, one of the key monocolins in red yeast rice extract.
The marketing of Cholestin (an extract of red yeast fermented on rice, standardized for monacolin content) as a dietary supplement in the United States has caused quite a controversy since 1997. Because it contains a natural source of a prescription drug, the FDA and the maker of Mevacor, Merck, tried to prohibit the sale of Cholestin and other red yeast rice extracts as a dietary supplement. The FDA’s ruling against Cholestin was temporarily reversed in March 1999, but two years later the FDAs ruling was upheld. Nonetheless, many red yeast rice products remain on the market.
These products, like their prescription counterparts, clearly are effective in lowering cholesterol levels. Over twenty clinical trials conducted in China involving thousands of subjects have shown red yeast rice extract to effectively lower high blood cholesterol levels by roughly 20 percent while raising protective HDL cholesterol by about 18 percent. A study conducted at the UCLA Center for Human Nutrition under the direction of David Herber, MD, has also demonstrated positive results. The double-blind, placebo-controlled study consisted of 83 healthy subjects with a cholesterol level between 200 and 239 mg/dl. Subjects were treated with 2.4 g of red yeast rice extract (Cholestin) supplying 9.6 mg of monacolins per day or a placebo. Both groups were instructed to maintain a diet of 30 percent fat with less than 10 percent saturated fat and less than 300 mg of cholesterol. On average, cholesterol decreased in the Cholestin group from 254 to 208 mg/dl by eight weeks, with no change in the placebo group.
While these results sound pretty good and from the outside looking in offer seeming support for this compound, the post-cycle time frame is NOT the time to employ potential use of this type of product.
First, it is a huge strike with those trying to use it with liver protectants post-C17 alkylated products. Liver enzyme elevations are reported as the number one side effect (3.4%). While this may not be a concern in the normal circumstance, the post-cycle period remains a unique time of recoup for all body organs – the liver perhaps having endured the biggest beating. Second, the development of muscle pains – perhaps indicative of a rare, but serious side effect known as rhabdomyolysis, are clearly evident in a few select cases (1%) of the general population. It is difficult to discern between post-workout DOMS and actual muscle pain due to this condition.
Red Yeast Rice like other statin drugs reduces the levels of Coenzyme Q10 at an alarming rate. With already depleted levels in many bodybuilders, this could play the role of a significant detriment to the well-being and attempts at regaining homeostatic environments seen prior to the cycle’s initiation. Niacin products at a dosage of 500 mg three times per day potentiates the effects of Red Yeast Rice and if employing either, it is strongly advised to avoid concurrent therapy. Interestingly enough, I will report a case of hepatic sides in an unknowing post-cycle patient using a Multi-Vitamin (containing Niacin products) and self-medicating with Red Yeast Rice later in this series. In addition, there are far too many drug-herb interactions – perhaps beyond the scope of this article to discuss, but it is wise to discuss the use of this product with your own examining physician if you are taking ANY prescription medications. I personally strongly advise AGAINST use of Red Yeast Rice at any point on or around a cycle.”
THE ORIGINAL COMPOUND IN ACTION (EFFICACY DEFINED)
PCT: ACV Part III:
“PRIMARY GOAL: HIGH LDL REDUCTION
Red Yeast Rice
EVIDENCE-BASED EFFICACY: ONLY two of the more than two dozen clinical studies using red yeast rice were done in the United States; the rest have been done in China. Taken as a whole, the studies have found that red yeast rice can lower cholesterol by 16 to 26 percent as well as lower triglyceride levels and raise beneficial HDL cholesterol. A recent study found that red yeast rice lowered blood cholesterol an average of 40 points over a twelve-week period compared to just 5 points in people who only made dietary changes. Benefits are greatest in people with total cholesterol levels above 200, the cutoff point of desirable cholesterol set by the American Heart Association.
FORMS & DOSAGES: The standard dose is two 600 mg capsules twice a day. It is sold in capsule form at pharmacies and health food stores, and it costs ONLY a fraction of what prescription statin drugs cost. Red Yeast Rice is recommended for people with borderline-high cholesterol levels (200 – 240) and NO other risk factors for heart disease. A low-fat diet is also recommended while taking the supplement. To avoid stomach upset, it should be taken with fluid or fluids.
POTENTIAL SIDE EFFECTS / INTERACTIONS: Minor side effects reported include heartburn, bloating, and dizziness. Because of its similarity to statin drugs, which should NOT be taken with niacin, erythromycin, cyclosporin, fibrates or other statin drugs, the same cautions should be applied to red yeast rice. Red yeast rice could cause some of the same side effects as statin drugs, including elevated liver enzymes (which is what you are trying to return to normal in the post cycle period), damage to skeletal muscle, and a possible increased risk of cancer! Individuals with severe liver or kidney damage need avoid this compound like the plague. NO ONE UNDER THE AGE OF 21 SHOULD TAKE RED YEAST RICE.
Dinoiii’s tip(s):
(1) Cholestin is the ONLY red yeast rice product that is standardized and that has been shown to be effective in clinical trials.”
THE STORIED PAST
From the article PCT:ACV III and 1/2:
“Q: Hey dinoiii, I thought that HMG-CoA reductase inhibitors like statin drugs were actually the best option in prevention of high cholesterol - in fact, contributing to a DECEASED MORTALITY in these kind of patients. Would not something like Red Yeast Rice be superior to niacin in our battle against cholesterol that is associated with cycle use.
A: I actually think this to be a good question because the mortality data is simply not there for other items (niacin being one) in the battle against cholesterol value changes - that is a great point. One of the reasons I have actually sided myself against Red Yeast Rice (and I cannot stress this point enough) is due to the changes specific to a predominance of cycles (i.e. - decreased HDL) as well as side effect profiles and the ability to guarantee actual standardization.
Red Yeast Rice has an interesting history. Its actually a product of yeast (Monascus purpureus) grown on rice and serves as a dietary staple in some Asian countries. It contains several compounds as I said in parts II and III known as “monocolins,” substances known to inhibit cholesterol synthesis. It is one of these, monocolin K, that has gained all the attention in the matter you describe - because it is a very potent inhibitor of HMG-CoA reductase and is the very same thing known as a common statin drug - lovastatin (Mevacor) - but this is where the problem begins.
Red Yeast Rice Extract (RYRE) has been sold as a natural cholesterol-lowering agent in over-the-counter supplements such as Cholestin. However, there has been legal and industrial dispute as to whether RYR is a drug or dietary supplement, involving the manufacturer of Cholestin (Pharmanex, Inc.), the FDA and the pharmaceutical industry (particularly makers of HMG-CoA reductase inhibitors/statins). It has actually been quite comical yet coninued interest by those such as myself because it is a battle that actually had more implication on differences between the supplement industry and pharmaceutics than the ole prohormone and ephedra wars of today as many are concerned of supplements as an industry holding any viability.
We have to trace back to the 1970s to see where human studies reporting Red Yeast Rice lowers blood cholesterol levels, LDL (”bad” cholesterol) and triglycerides. The pharmaceutic industry responded by bringing to market Mevacor and it was years later and then low and behold government/FDA obviously favors in support of the drug company - which did IN NO WAY own the novelty of such a compound like this.
In March 2001, a U.S. District Court ruled that the RYRE product Cholestin contains the same chemical as the prescription med. HUH? This is obviously a chicken and egg argument and the government wins - long-live democracy! How can a company like Pharmanex respond? They have since reformulated their product with different ingredients (still marketing under the same name - cholestin), such as policosanol [according to their website, they have NO more RYR in the product in fact, but this is a simple claim which may have lent some credibility to policosanol efficacy - but that latter part is just an assumption]. Other products claim RYRE, however, these products may NOT be standardized and I can bet you if makers of Mevacor thought they did - the attacks would be the same.
The side effects with this product CANNOT be judged appropriately by the average RYRE taker I am afraid and when bodybuilders engage in taking it, the liver side effects are too high (namely in the realm of C17 alkylated products) and it would be hard to judge Rhabdomyolysis when - if you are in the process of coming off of increasing poundages with DOMS playing a direct role - early outward signs of this potentially deadly side effect simply can be hidden. I STRONGLY SUGGEST AGAINST ITS USE IN THE GREATER SENSE OF THE PRODUCT VERSUS ANY POTENTIAL OR MORBIDITY/MORTALITY POTENTIAL. It may contribute just as easy to higher morbidity/mortality as it may alter it. As far as I am concerned - the niacin (no-flush protocol) I have initroduced in parts II and III rules.”
Red Yeast Rice - It’s Storied Past and why you SHOULDN’T use it!
April 29, 2007
Author’s Note: I have summarized the various Red Yeast Rice components from post cycle therapy: A Clinician’s View (ACV) below. I think this is a good summary of my collective thoughts on Red Yeast Rice plus invites you to look at the storied past of compounds like this in making decisions on what to employ when considering support supplementation, whether it be cholesterol-support (as in this instance), or otherwise.
HISTORY & SUGGESTION
post cycle therapy: ACV Part II: “PRIMARY GOAL: HIGH LDL REDUCTION
Red Yeast Rice
The red yeast (Monascus purpureus) fermented on rice has been used in China for its health-promoting effects for over 2000 years. This yeast is the source of a small group of compounds known as monacolins that can lower cholesterol levels by blocking a key enzyme in the liver. In fact, the cholesterol-lowering drug Mevacor, the trade name for the compound lovastatin, also known as monacolin K, one of the key monocolins in red yeast rice extract.
The marketing of Cholestin (an extract of red yeast fermented on rice, standardized for monacolin content) as a dietary supplement in the United States has caused quite a controversy since 1997. Because it contains a natural source of a prescription drug, the FDA and the maker of Mevacor, Merck, tried to prohibit the sale of Cholestin and other red yeast rice extracts as a dietary supplement. The FDA’s ruling against Cholestin was temporarily reversed in March 1999, but two years later the FDAs ruling was upheld. Nonetheless, many red yeast rice products remain on the market.
These products, like their prescription counterparts, clearly are effective in lowering cholesterol levels. Over twenty clinical trials conducted in China involving thousands of subjects have shown red yeast rice extract to effectively lower high blood cholesterol levels by roughly 20 percent while raising protective HDL cholesterol by about 18 percent. A study conducted at the UCLA Center for Human Nutrition under the direction of David Herber, MD, has also demonstrated positive results. The double-blind, placebo-controlled study consisted of 83 healthy subjects with a cholesterol level between 200 and 239 mg/dl. Subjects were treated with 2.4 g of red yeast rice extract (Cholestin) supplying 9.6 mg of monacolins per day or a placebo. Both groups were instructed to maintain a diet of 30 percent fat with less than 10 percent saturated fat and less than 300 mg of cholesterol. On average, cholesterol decreased in the Cholestin group from 254 to 208 mg/dl by eight weeks, with no change in the placebo group.
While these results sound pretty good and from the outside looking in offer seeming support for this compound, the post-cycle time frame is NOT the time to employ potential use of this type of product.
First, it is a huge strike with those trying to use it with liver protectants post-C17 alkylated products. Liver enzyme elevations are reported as the number one side effect (3.4%). While this may not be a concern in the normal circumstance, the post-cycle period remains a unique time of recoup for all body organs – the liver perhaps having endured the biggest beating. Second, the development of muscle pains – perhaps indicative of a rare, but serious side effect known as rhabdomyolysis, are clearly evident in a few select cases (1%) of the general population. It is difficult to discern between post-workout DOMS and actual muscle pain due to this condition.
Red Yeast Rice like other statin drugs reduces the levels of Coenzyme Q10 at an alarming rate. With already depleted levels in many bodybuilders, this could play the role of a significant detriment to the well-being and attempts at regaining homeostatic environments seen prior to the cycle’s initiation. Niacin products at a dosage of 500 mg three times per day potentiates the effects of Red Yeast Rice and if employing either, it is strongly advised to avoid concurrent therapy. Interestingly enough, I will report a case of hepatic sides in an unknowing post-cycle patient using a Multi-Vitamin (containing Niacin products) and self-medicating with Red Yeast Rice later in this series. In addition, there are far too many drug-herb interactions – perhaps beyond the scope of this article to discuss, but it is wise to discuss the use of this product with your own examining physician if you are taking ANY prescription medications. I personally strongly advise AGAINST use of Red Yeast Rice at any point on or around a cycle.”
THE ORIGINAL COMPOUND IN ACTION (EFFICACY DEFINED)
PCT: ACV Part III:
“PRIMARY GOAL: HIGH LDL REDUCTION
Red Yeast Rice
EVIDENCE-BASED EFFICACY: ONLY two of the more than two dozen clinical studies using red yeast rice were done in the United States; the rest have been done in China. Taken as a whole, the studies have found that red yeast rice can lower cholesterol by 16 to 26 percent as well as lower triglyceride levels and raise beneficial HDL cholesterol. A recent study found that red yeast rice lowered blood cholesterol an average of 40 points over a twelve-week period compared to just 5 points in people who only made dietary changes. Benefits are greatest in people with total cholesterol levels above 200, the cutoff point of desirable cholesterol set by the American Heart Association.
FORMS & DOSAGES: The standard dose is two 600 mg capsules twice a day. It is sold in capsule form at pharmacies and health food stores, and it costs ONLY a fraction of what prescription statin drugs cost. Red Yeast Rice is recommended for people with borderline-high cholesterol levels (200 – 240) and NO other risk factors for heart disease. A low-fat diet is also recommended while taking the supplement. To avoid stomach upset, it should be taken with fluid or fluids.
POTENTIAL SIDE EFFECTS / INTERACTIONS: Minor side effects reported include heartburn, bloating, and dizziness. Because of its similarity to statin drugs, which should NOT be taken with niacin, erythromycin, cyclosporin, fibrates or other statin drugs, the same cautions should be applied to red yeast rice. Red yeast rice could cause some of the same side effects as statin drugs, including elevated liver enzymes (which is what you are trying to return to normal in the post cycle period), damage to skeletal muscle, and a possible increased risk of cancer! Individuals with severe liver or kidney damage need avoid this compound like the plague. NO ONE UNDER THE AGE OF 21 SHOULD TAKE RED YEAST RICE.
Dinoiii’s tip(s):
(1) Cholestin is the ONLY red yeast rice product that is standardized and that has been shown to be effective in clinical trials.”
THE STORIED PAST
From the article PCT:ACV III and 1/2:
“Q: Hey dinoiii, I thought that HMG-CoA reductase inhibitors like statin drugs were actually the best option in prevention of high cholesterol - in fact, contributing to a DECEASED MORTALITY in these kind of patients. Would not something like Red Yeast Rice be superior to niacin in our battle against cholesterol that is associated with cycle use.
A: I actually think this to be a good question because the mortality data is simply not there for other items (niacin being one) in the battle against cholesterol value changes - that is a great point. One of the reasons I have actually sided myself against Red Yeast Rice (and I cannot stress this point enough) is due to the changes specific to a predominance of cycles (i.e. - decreased HDL) as well as side effect profiles and the ability to guarantee actual standardization.
Red Yeast Rice has an interesting history. Its actually a product of yeast (Monascus purpureus) grown on rice and serves as a dietary staple in some Asian countries. It contains several compounds as I said in parts II and III known as “monocolins,” substances known to inhibit cholesterol synthesis. It is one of these, monocolin K, that has gained all the attention in the matter you describe - because it is a very potent inhibitor of HMG-CoA reductase and is the very same thing known as a common statin drug - lovastatin (Mevacor) - but this is where the problem begins.
Red Yeast Rice Extract (RYRE) has been sold as a natural cholesterol-lowering agent in over-the-counter supplements such as Cholestin. However, there has been legal and industrial dispute as to whether RYR is a drug or dietary supplement, involving the manufacturer of Cholestin (Pharmanex, Inc.), the FDA and the pharmaceutical industry (particularly makers of HMG-CoA reductase inhibitors/statins). It has actually been quite comical yet coninued interest by those such as myself because it is a battle that actually had more implication on differences between the supplement industry and pharmaceutics than the ole prohormone and ephedra wars of today as many are concerned of supplements as an industry holding any viability.
We have to trace back to the 1970s to see where human studies reporting Red Yeast Rice lowers blood cholesterol levels, LDL (”bad” cholesterol) and triglycerides. The pharmaceutic industry responded by bringing to market Mevacor and it was years later and then low and behold government/FDA obviously favors in support of the drug company - which did IN NO WAY own the novelty of such a compound like this.
In March 2001, a U.S. District Court ruled that the RYRE product Cholestin contains the same chemical as the prescription med. HUH? This is obviously a chicken and egg argument and the government wins - long-live democracy! How can a company like Pharmanex respond? They have since reformulated their product with different ingredients (still marketing under the same name - cholestin), such as policosanol [according to their website, they have NO more RYR in the product in fact, but this is a simple claim which may have lent some credibility to policosanol efficacy - but that latter part is just an assumption]. Other products claim RYRE, however, these products may NOT be standardized and I can bet you if makers of Mevacor thought they did - the attacks would be the same.
The side effects with this product CANNOT be judged appropriately by the average RYRE taker I am afraid and when bodybuilders engage in taking it, the liver side effects are too high (namely in the realm of C17 alkylated products) and it would be hard to judge Rhabdomyolysis when - if you are in the process of coming off of increasing poundages with DOMS playing a direct role - early outward signs of this potentially deadly side effect simply can be hidden. I STRONGLY SUGGEST AGAINST ITS USE IN THE GREATER SENSE OF THE PRODUCT VERSUS ANY POTENTIAL OR MORBIDITY/MORTALITY POTENTIAL. It may contribute just as easy to higher morbidity/mortality as it may alter it. As far as I am concerned - the niacin (no-flush protocol) I have initroduced in parts II and III rules.”