09/06/2010 01:00 AM EDT
By Elspeth Lodge
journal Staff Writer
The Providence Journal
High blood cholesterol is a problem facing approximately one in every six adults or 17 percent of the adult U.S. population, according to the Centers for Disease Control. More women than men have high cholesterol in the country.
And because of the high risk of heart disease associated with total cholesterol levels higher than 200 mg/dL, many are turning to both traditional and alternative medicines to help control their cholesterol numbers.
Health food stores around Rhode Island have been touting the benefits of red yeast rice, a non-prescription cholesterol-lowering supplement made from cultivating rice with the mold monascus purpureus, according to Richard M. Fogoros, M.D., author of the about.com article, “Non-prescription Cholesterol Lowering Red Yeast Rice.”
The Chinese have used the supplement for centuries to treat circulatory and digestive disorders and according to redyeastrice.org, the supplement is also used in china as a preservative, food colorant, spice, and in rice wine.
But red yeast rice has been used for a much shorter period of time in the United States, and has been the subject of much controversy and confusion. In 1999 clinical trials red yeast rice was shown to effectively lower cholesterol, but only because it is directly related to a naturally occurring form of the statin drug Lovastatin (or Mevacore). The naturally occurring form in the red yeast rice is known as Monacolin K..
The FDA then ruled that the supplement should be regulated and it was pulled from the shelves, but the decision was initially overruled by The District Court of Utah in 1999. In 2000 the 10th U.S. Circuit Court of Appeals agreed with FDA’s decision for regulation. What did this ruling mean? Red yeast rice could still be sold legally in the U.S., but only if the manufacturers of the product removed the natural form of Lovastatin, which would presumably eliminate its effectiveness on cholesterol levels.
In 2007 the FDA found that many of the supplements being sold in the U.S. still contained Lovastatin. A formal FDA safety consumer alert was issued and they took steps to remove the products that still contained Lovastatin from the shelves.
Despite the FDA’s steps, the formulation and content of the supplement is not regulated. It is almost impossible to find out what the pills on your market’s shelf contain.
What you are ingesting, presumably, is a mystery pill with unproven effects. Redyeastrice.org suggests not taking the product for extended periods of time because little is known about its safety or the side effects, which, they say can include headache, stomach ache and/or bloating, gas, dizziness and heartburn.
According to Fogoros, a 2009 University of Pennsylvania study showed that 60 patients who stopped taking the prescription statin drugs due to muscle pain opted to take red yeast rice along with a 24-week lifestyle change regime reduced total and LDL cholesterol levels compared to taking a placebo and making the same lifestyle changes.
But, the product used in their study, still on the shelves, was found to contain Lovastatin.
Fogoros says that when you take any of the red yeast rice brands you are ingesting varying amounts of statin-like substances–– what it comes down to is it is impossible to know what and how much of it you are really ingesting when you take one of these supplements.