While much of CAM is ridiculous or implausible, herbal remedies are an exception. Plants produce pharmacologically active substances; in fact, the science of pharmacology grew out of herbalism. Some herbal remedies have not been scientifically tested, but others have been tested and are clearly effective. Nevertheless, these are seldom if ever the best choice for treatment.
One natural remedy stands out. Red yeast rice has been tested and has been shown to lower cholesterol as well as a statin drug. That’s hardly surprising when you realize that it contains the exact same ingredient as the pharmaceutical drug lovastatin.
Only it doesn’t any more.
Origin
Red yeast rice has been widely used in Asian cuisines as a coloring agent and taste enhancer. It has been used in traditional Chinese medicine for centuries for indigestion, diarrhea, blood circulation, and spleen and stomach health.
Preparation
It is prepared by fermenting rice with the yeast Monascus purpureus. It contains eight mevinic acids (statins), mainly lovastatin or monacolin K. It also contains sterols and other components. Its overall cholesterol-lowering effect may be due to a combination of several of its constituents. In manufacturing it for use as a supplement, temperature and growing conditions are carefully controlled to increase the concentration of mevinic acids. These products are not the same as the red yeast rice sold in Chinese grocery stores.
Safety concerns
The safety of red yeast rice has not been established. The Natural Medicines Comprehensive Database only gives it a “possibly safe” rating. Since it contains lovastatin, it can be expected to have the same side effects as the prescription drug. Patients on statins are monitored for liver, muscle, and kidney damage; sellers of red yeast rice do not usually inform their customers of those risks. There are also a number of interactions with other drugs and dietary supplements. And eating grapefruit can affect blood levels of lovastatin.
Regulatory actions
When does a food cross the line to become a drug? Red yeast rice was marketed in the US as a dietary supplement, Cholestin. The FDA banned it in 1998, saying that since it contained lovastatin it was an unapproved drug. In 1999, a federal judge overruled the FDA, saying it could be sold as a food supplement. In 2000 a Circuit Court of Appeals said that ruling was in error and restored the FDA’s ability to regulate Cholestin as a drug. The FDA then sent warning letters to several companies, and the product disappeared from the market for a few years.
The manufacturers’ response
Red yeast rice products gradually reappeared on the market. Around 30 brands are now available. Most of them got around the FDA restriction by eliminating the monacolin content and by careful labeling and advertising that does not claim to lower cholesterol. In 2007, the FDA sent warning letters to two companies whose products still contained monacolins; the products were withdrawn. Red yeast rice products are still widely sold in the US and products containing lovastatin are still readily available from other countries.
Pharmanex continues to sell a product under the name Cholestin, but it no longer contains lovastatin. They say:
Cholestin® is a breakthrough all-natural solution for individuals concerned with maintaining cholesterol levels already in the normal range.
Cholestin’s proprietary blend contains polymethoxylated flavones extracted from citrus fruits, geraniol and the essential fatty acids EPA and DHA found in marine lipids. Each individual constituent has been shown to control existing normal cholesterol levels in the body and promote overall cardiovascular health. Only Pharmanex’s new Cholestin® offers this unique blend of scientifically-tested constituents for effective cholesterol management.
Pharmanex sells Cholestin for around a dollar a pill. Theprice of lovastatin varies from 29 cents to $1.71 per pill
CAM recommendations
Dr. Andrew Weil recommends red rice yeast extracts, saying they are by far the most effective natural supplement for lowering cholesterol and claiming that they are less likely to cause side effects than prescription statins.
Dr. Oz says red yeast rice is a statin that will lower your cholesterol by 30 points.
Dr. Mercola says red yeast rice is a statin and all statins should be avoided.
Natural News recommends it but notes that supplements currently sold in the US don’t contain any of the active ingredient.
Many websites have outdated and false information.
Other herbal remedies
My general objections to herbal medicines are these:
- When tested, isolated active ingredients tend to work at least as well as the whole plant derivative.
- Although herbalists claim that the other components in their remedies act synergistically, that has seldom been substantiated, and the other ingredients might just as well be expected to do harm or to decrease the effect of the active ingredient.
- Most herbal products have not been adequately tested to ensure safety.
- Herbal products on the market vary in dosage and purity. There is no guarantee that you will get what the label says.
- Products may contain contaminants. Products have been found to contain everything from toxins to insect parts and even prescription drugs.
I see no good reason to prefer St. John’s wort to a prescription antidepressant. On a practical basis, I can understand that some people might prefer it because it is less expensive and can be acquired without a visit to a doctor with all the inconvenience and cost that entails. But I think their health would be better served by being diagnosed and regularly monitored by a medical doctor and by taking a pure antidepressant in a controlled dosage.
Conclusion
Red yeast rice containing lovastatin is effective in lowering cholesterol, but brands currently sold in the US contain no lovastatin. It’s ironic that one of the few proven CAM treatments was effective only because it contained a drug available by prescription. And that they continue to recommend it after the lovastatin was removed. Even if a lovastatin-containing red yeast product can be obtained, concerns remain about purity and safety. It would be hard to justify recommending it over a pharmaceutical statin.
This article was originally published in the Science-Based Medicine blog.
