Over-the-counter Red Yeast Rice Extract Versus Conventional Prescription Statins

Sacramento - Jan. 25, 2010: You need to make sure your red yeast product, if you take one, does not have the toxic fermentation by-product, citrinin in it. You don't want this mold toxin in any supplements.

Citrinin is a mycotoxin that's capable of damaging your kidneys and doing other genetic damage. So look for a product free of citrinin, such as Wakunaga's Kyolic Formula 107 red yeast rice, which is free of citrinin." Also see the Jan. 19, 2010 Medical News Today article, "Higher Statin Doses Not Always Best At Preventing Coronary Artery Disease."

Watch out for sites on the Internet where you can't find out the information you need to know. If you have never heard of a vitamin company or the site doesn't have resources for more information and references to medical journal articles or clinical studies in a language you can read on the particular product you want, be careful. Read the article on red yeast rice extract published by the Mayo Clinic, "Red yeast rice (Monascus purpureus) - MayoClinic.com.

Here's what the big debate is about when it comes to statins prescribed by doctors versus over-the-counter products such as red yeast rice. Chinese red yeast rice extract is a natural source of an active ingredient in many statin drugs called lovastatin. Doctors look at the differences in the formation of the molecules in red yeast rice compared to prescribed statins to find out which is safer for specific conditions and individuals.

On one hand, red yeast rice supplements appear to hold heart benefits, and on the other, some doctors urge caution in their use. But why are doctors considering prescribing statins to teenagers and even children? Some pediatricians recommend statins for children with high cholesterol.

As many as one in five American adolescents has LDL (bad) cholesterol levels that are too high and HDL (good) cholesterol levels that are too low -- a fact that many doctors say means that it may be time to start regular cholesterol screening as part of back-to-school check-ups.

According to a new report from the U.S. Centers for Disease Control and Prevention, American teens -- already identified as too often out-of-shape and overweight -- are also at risk for cholesterol problems once thought to be seen only in the middle-aged.

The CDC, which released the new cholesterol findings in its Jan. 22, 2010 issue of Morbidity and Mortality Weekly Report, reported high triglyceride levels are also a problem for adolescents.

The numbers come from a nationwide survey conducted from 1999 through 2006 known as the National Health and Nutrition Examination Survey (NHANES). This survey found that 20.3 percent of 12- to 19-year-olds had higher-than-normal levels of LDL cholesterol or triglycerides, or low levels of HDL cholesterol.

The debate is about, should children and teenagers take statins? And should adults take red yeast rice instead? If your doctor prescribes red yeast rice, what should you look for?

First make sure the potentially toxic by-product, citrinin has been removed from the fermentation process. You only want to use the extract form of red yeast rice. What other supplements should you use along with red yeast rice?

Red yeast rice has been shown to normalize cholesterol as well or better than cholesterol-lowering drugs. Efficacy and safety have been proven in numerous clinical trials, and it has been used by millions of people in other countries for 2,000 years or more. (It's a regular diet staple in Asia and is the source of the rich red color in Peking Duck.)

Some doctors and/or nutritionists suggest using in conjunction with red yeast rice products such as the following, according to the Real Cholesterol Answers website,

• Sytrinol®
• Co-Q10
• Policosanol(make sure it contains specific "octacosanol" and not the cheaper form of "beta-sistosterol")
• Garlic Extract (make sure it's Deodorized with 1.3% alliin)
• Pantesin® d-Pantethine
• Guggulsterones (make sure it's 10% Pure Extract; E and Z)
• Artichoke Leaf Extract (make sure it's 15% Chlorogenic Acid, 5% Cynarin)
• Phytosterols Complex

Some doctors and nutritionists suggest taking a safe liver cleansing formula to get at the root of the problem where cholesterol problems start-in your liver. Some experts also suggest you reduce your homocycteine levels if they are high, since too-high homocysteine levels are the cause of 43 percent of certain types of heart attacks.

What you want to find out from the experts is if you combine the various ingredients, will you be able to take a much lower dose of red yeast rice, a form of lovastatin, and still get more positive effects?

On the opposite side of the issue, many doctors urge caution in the use of Chinese red yeast rice extract because the active ingredient in it is a natural form of lovastatin. Yet, in a study of 5,000 Chinese heart attack patients, researchers at Thomas JeffersonThomas Jefferson University's Myrna Brind Center of Integrative Medicine compared red yeast rice extract pills to a placebo treatment.

The researchers found those subjects taking the red yeast rice pills cut their risk of repeat heart attacks by nearly one half. See the press release explaining the 2007 study, "Chinese Red Yeast Rice Reduces Repeat Heart Attacks/Mortality Rates."

These patients also reduced their chances of having a heart procedure, such as bypass surgery or angioplasty, and their risk of dying from cancer also appeared to be reduced by as much as two-thirds.

According to the university's press release, "Chinese Red Yeast Rice Reduces Repeat Heart Attacks/Mortality Rates," a clinical study on patients who have suffered a heart attack found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds.

The multicenter, randomized, double-blind study, was conducted on almost 5,000 patients, ranging in age from 18-70 over a five-year period at over 60 hospitals in the People's Republic of China. Corresponding author David M. Capuzzi, M.D., Ph.D, director of the Cardiovascular Disease Prevention Program at Jefferson's Myrna Brind Center of Integrative Medicine and Zonliang Lu, M.D., Ph.D, from the Fuwai Hospital at the Chinese Academy of Medical Science report their findings in the June 15th edition of the American Journal of Cardiology.

"It's very exciting because this is a natural product and had very few adverse side effects including no abnormal blood changes," said Capuzzi. "People in the Far East have been taking Chinese red yeast rice as food for thousands of years, but no one has ever studied it clinically in a double-blind manner with a purified product against a placebo group until now and we are pleased with the results.

However, people in the United States should know that the commercially available over-the-counter supplement found in your average health food store is not what was studied here. Those over-the-counter supplements are not regulated, so exact amounts of active ingredient are unknown and their efficacy has not been studied yet."

The study looked at patients who had suffered a heart attack in the previous year. Study participants were given two-300-milligram XZK capsules or a placebo and tracked over a five-year period. The XZK capsules contained a combination of lovastatin, lovastatin hydroxyl acid, ergosterol and other components.

"I think it is surprising that a natural product like XZK would have this great an effect," said Capuzzi. "If further testing and study prove true, my hope is that XZK becomes an important therapeutic agent to treat cardiovascular disorders and in the prevention of disease whether someone has had a heart attack or not. But it is important to recognize the fact we do not know exactly how Chinese red yeast rice works.

The exact ingredients from the XZK capsules have not been isolated and studied yet. Still the results were so profound, even out performing statins prescribed in numerous western populations, that further study should certainly be investigated."

The study was sponsored by Beijing Peking University WBL Biotech Co. Ltd (WPU), in Beijing, People's Republic of China. Dr. Capuzzi has no financial interest in this company.

The results were a surprise, the researchers wrote in their article. But they cautioned that their findings deserve more study. And they also urged those with high cholesterol not rush out to buy these supplements, as the pills may contain unsafe doses of lovastatin or contain harmful ingredients.

Doctors Are Divided on Red Yeast Rice Extract

Heart experts are divided on whether the red rice yeast extract should be suggested as a treatment option to heart patients. A lot of people get muscle pain when they take statins and can't tolerate prescription statins. But what are their symptoms or side effects when these types of patients switch to over-the-counter red rice yeast extract? Their liver enzymes still have to be tested to find out how the red yeast rice extract is affecting their liver, since the rice extract contains lovastatin, even if the molecule formation is a bit different from the commercial statin drugs.

Experts as well as consumers want to know how do you know the level of statin you're getting from red yeast rice extract? If some supplements are not standardized, how do you know what dose you're getting? And if some supplements are standardized, how do you find out which products are and what levels of statins are in the various brands? Which brands are toxin-free, especially free from citricin?

The problem is that you don't know which brands of statin are purified and which are standardized, which contain the toxin, citricin, and which are free of it. And how do you know what's on the label of any brand of over-the-counter supplements contains what's in the bottle?

That's what the big debate is about when it comes to supplements. But patients who find statins cause them muscle pain may want products that work without the pain or other side effects. And if statins take out the COQ10 from your body, how do you know to replace the COQ10 unless it's already in the supplement or somebody tells you to take it and why you have to?

When doctors prescribe a statin, how many tell their patients they also need to replace the COQ10 that the statin removes? Or how much to take? Unless you're going to a cardiologist familiar with supplements and integrative medicine, how do you get the big picture of what works best for you?

The U.S. Food and Drug Administration released a warning to consumers in August 2007 not to buy or eat three specific red yeast rice products promoted and sold on Web sites. The FDA found that since these products contained the same active ingredient as a prescription medicine, they are unauthorized to be sold over-the-counter or online.

Consumers would like to know which product is most reliable. Who tests the products as independent laboratories? The debate also is between conventional medicine doctors and integrative medicine experts that suggest to patients or clients studies on red yeast rice found in health food stores or purchased online.

The question is whether the rice extract that says it's free of citrinin is really free of the toxin? Only an independent lab test can tell you such an answer before you decide on buying a particular supplement.

What brands are reliable? Should you buy from health food store chains rather than online? And have the health food chain stores had the products independently tested?

You might consult preventive cardiology experts. You'll find them at cardiovascular institutes. Some doctors do recommend red yeast rice extract to heart patients that can't tolerate other types of statins, since red yeast rice contains a different molecular form of lovastatin than the usual prescribed commercial or conventional drugs.

For some patients, red yeast rice can help, if it's free of toxins, for patients who would otherwise not take any medicine. The question is finding reliable products. Where are you going to buy the red yeast rice extract from? What's in it? Those are the questions your doctor wants to know. How safe are the nationally famous brands?

If you want to start looking at red yeast rice extract, you might talk to your doctor and also research Kyolic Formula 107 Red Yeast Rice. You can talk to the company at Wakunaga. They have a toll-free number listed on their website.

Or check out the information on their website. Ask your doctor whether you need to combine red yeast rice extract with niacin and other B-vitamins to lower your homocysteine level, if it is high. Unless you have a blood test to find out whether you need these supplements, you won't know whether you have to take any supplements.