I have had increasing numbers of patients who come to me who are using Red Yeast Rice (RYR) as the only means to treat their high cholesterol. Many people make the assumption that this is a “natural medicine” and that it is
completely safe to use and actually works. Unfortunately, RYR is not the wonder
drug that many folks think that it is and may actually be harmful as I will explain.
One must remember that in 2008, there were many products manufactured in
China that were found to be tainted with lead and melamine, to name a few of
Red Yeast Rice extract is the fermented product of rice on which red yeast has
been grown . The active ingredient in red yeast rice is believed to be Monacolin
K, an agent reported to be identical to lovastatin (a commonly prescribed statin).
Like statins, red yeast has been found to directly reduce lipids. There is little
doubt that the proprietary preparation of red yeast rice, known as Cholestin
favorably alters lipids. However, due to legal issues, this preparation is no longer
commercially available in the US. In 1998, the FDA determined that red yeast
rice did not conform to the definition of a dietary supplement under the 1994 Diet
supplement and Health Education Act (DSHEA). This act states that marketed
dietary supplements cannot contain a compound already approved as a drug (in
this case, lovastatin) unless the substance was available commercially before the
drug's approval. At present, Cholestin is still available in Canada, Europe and
Asia – however, great caution should be exercised because Cholestin has been
reformulated and no longer contains the important Red Yeast Rice extract, but
rather polymethoxylated flavones extracted from citrus fruits, geraniol and marine
fish oils. It is unclear if this or other proprietary preparations of red yeast extract
will provide the same lipid effects. The FDA has issued a warning to consumers
regarding three brands of red yeast rice. Follow this link for more information.
www.fda.gov and type in red yeast rice in the search box.
As a result of a study published in the June 15, 2008 issue of the American
Journal of Cardiology, the National Lipid Association felt compelled to write an
official statement on this RYR study. This study suggested that a new ingredient
of RYR, called Xuezhikang (XZK), may have significant benefits. The published
study was a randomized, double-blind, placebo study conducted in Chinese
hospitals on 4,870 patients who had a previous heart attack within the past 5
years. The primary endpoint was the occurrence of a major coronary event or
death from coronary or cardiac causes. The striking findings of this study are the
45% reduction of the relative risk of major coronary events and the statistically
significant reductions in CV and total mortality The NLA recommended that
physicians and patients should beware that the composition of this product is not
yet known and any future use will depend on the results of ungoing studies.
XZK is produced by the Beijing WBL Peking University Biotech Co. Ltd and is the
purified extract of Chinese RYR with multiple components. This product is not
sold in the USA, lacks FDA approval, and is not identical to other products sold in
the USA as “red yeast rice”. This does not mean that this particular brand is not
brought into this country illegally. Like the product known as Cholestin, XZK
contains lovastatin, plants sterols, and isoflavones. At the present time, it is not
known to what extent, if any, lipid- lowering accounts for treatment benefit.
To summarize the current thought on this preparation and all other types of RYR,
1. Physicians should not advise patients to take any RYR supplement as
efficacy has not been proven for any indication.
2. If you are taking a medicine for cholesterol management, continue to take
your prescripton. Do NOT add any RYR to your current medications as
adverse effects may be more likely.
3. RYR should not be substituted for statins. The active ingredients of any of
the preparations currently sold in the USA are unknown