CNN Interviews Natural Standard

CNN recently interviewed Dr. Catherine Ulbricht, co-founder of Natural Standard and Senior Attending Pharmacist at Massachusetts General Hospital, about the safety and effectiveness of red yeast rice supplements, which are popularly used to lower cholesterol.

The news article highlights a recent study that found that red yeast rice supplements may contain varying amounts of monacolins, the active ingredients responsible for their cholesterol-lowering effects. One of these ingredients, monacolin K, has the same chemical structure as the prescription drugs lovastatin and mevinolin.

The researchers purchased 12 commercial red yeast rice supplements and analyzed them for their monacolin content. Although the products were said to contain 600 milligrams of red yeast rice, they contained anywhere from 0.31 to 11.15 milligrams of monacolins per capsule.

Many supplements, including red yeast rice, are not standardized to contain specific ingredients or dosages, Dr. Ulbricht told CNN.

Four of the supplements also contained detectable amounts of citrinin, a toxin that has been shown to cause kidney damage in animals.

Red yeast rice has also been studied as a potential therapy for coronary artery disease and diabetes, although evidence of effectiveness is currently inconclusive in these areas.

For more information about red yeast rice, please visit Natural Standard's Foods, Herbs & Supplements database. To schedule an expert interview or book signing with Dr. Ulbricht, please e-mail questions@naturalstandard.com.

Comments

[Juneli]

The FDA has no role in regulating supplements, and this is the perfect example of major side effects that can results from them. What a pity! We could only hope that patients would talk to their healthcare providers before starting any kind of dietary supplement.

[Darren]

If you think about the process of extracting the active alkaloids and flavonoids and sesquiterpenes, you'll start to see that there are similarities to the drug manufacturing process. A lot of natural products are not roots or leaves that you chew on. I think this finding with red yeast rice is an excellent example.

[TLC]

Ryan makes a good point. There are definitely issues with standardization among different brands, and within brands themselves. However, with some research, you can find a company that has a good reputation and try to stick with it. When a relationship is formed with a company, it is easier to trust that you are getting what you want in a product. In this technological age, we can call, e-mail, fax, etc., a company and ask questions, too! We cannot simply state that getting CAM is impossible because of a lack of standardization because it is just not true.

[Ana]

It is shocking to see the differences in the products. Without standards, how is anyone suppose to know how much they are taking?

[LillianC]

I have been aware of the lovastatin content of red yeast rice for quite a while now. It has definitely factored into numerous counseling sessions I have had with patients. They are always extremely surprised when I explain to them that there is a statin in an OTC herbal product, especially considering the high level of scrutiny that statins have recently received for their adverse effects. The problem really comes into play when it is a patient who is already taking a statin. Red yeast rice is a great product, but buyer be ware.

[Ryan]

This is a problem that’s seen across the entire herbal supplement industry. Finding trustworthy brands can be time consuming, but the extra research can go a long way. Beyond educating ourselves as consumers, a broader dialogue could help ensure the safety of those who use these products while creating demand in the right places.

[DC3]

I agree with Tim. Although I think it's great that there are so many up-and-coming natural products, price is definitely something to consider. I think it's important to look at things on a case-to-case basis. It is definitely difficult to recommend products when they're not standardized, and in a world where there are $4 generics, I would feel more comfortable recommending lovastatin in this case. Intriguing topic!

[Christine]

Vivian Chen, you make a very good point. How do we know what companies to buy from when there are so many inconsistencies in manufacturing practices of natural products. Every time an article like this comes out, it has us wondering who we can trust. I recently had the opportunity to visit the United States Pharmacopeia, and to my surprise, learned that they have created reference standards and guidelines for manufacturing for not only medicines, but also for dietary supplements.

In their words: "To help healthcare professionals and consumers identify quality supplements, USP operates a separate "verification" program for dietary supplements. Manufacturers can voluntarily submit their products for testing by USP, and dietary supplements that meet the program's strict criteria are awarded the USP Verified Mark."

Within this program, they actually test the supplements to ensure quality, purity and potency; audit the manufacturing facilities; test marketplace samples and review labels to make sure the listed ingredients are actually what can be found in the product. There are probably other companies that do this as well, but at least we know if we see the USP seal, we should be able to trust the supplement is what it says it is.

To find more information about this verification process and the companies that sell approved products, go here: http://www.usp.org/USPVerified/dietarySupplements/

[CH]

I found it interesting from this article that manufacturing companies are not actually allowed to list the amount of monacolins in their products due to the laws surrounding the marketing of red yeast rice. It is a particularly tricky supplement because this active ingredient is regulated by the FDA. It is good at least that this has been brought to the attention of the FDA, but unfortunately, it is out of their jurisdiction to regulate any more than sending a warning letter to these companies. It makes me wonder, if companies were able to provide the monacolin content on the packaging, would they? And if they did, would it make them more accountable to create a product that actually has the amount that they put on the label?

[MW]

Many people have the misconception that natural products are safer or at least harmless. It’s a real wake up call when you find that these products can, like anything else that’s available, hurt you. I only hope that people have access to this information so that they can make the best choice for their situation.

[Cindy]

The fact that dietary supplements are not as tightly regulated as prescription drugs makes it really difficult for us to recommend a specific product to a patient. How can we be sure that the therapeutic effect from the active ingredient outweighs the potential toxic effects of unknown contaminants?

[Karen]

I really enjoyed this article! It makes me wonder if maybe the makers of lovastatin, came up with the structure from doing studies on red yeast rice! A lot of prescription drugs on the market are developed after researching natural products. Sometimes they keep the same chemical structure that they isolated from the natural product, and other times they alter it! In the case of lovastatin, I might do some research to find out where they got the chemical structure from!

[CJF]

The lack of regulation in the natural products market is scary. The general consumer is easily fooled by marketing tools and attractive packaging. I also agree with RPO’s comments. The potential interactions among these products, especially if we don’t really know what is in them, could be deadly. This study is just the tip of the iceberg when it comes to the misinformation currently presented to the public.

[Tiffany]

Although there are many worthwhile alternatives to prescription medications, I am very glad that this has been brought to the attention of consumers. It is sometimes difficult to explain to our patients that we don't always know what is in an alternative product because it isn't regulated. Also, that just because it is natural, doesn't automatically make it better or safer. It sometimes seems like patients think we are saying this just so they purchase their prescriptions. If this article helps one person make a better choice, then it has done its job.

[RPO]

I have seen patients want to take this drug in addition to their prescribed statins. They have no idea that this can cause interactions and adverse effects because of the statin component (whatever the amount) in red yeast rice. Education about these supplements is vital, and it is scary to see the huge variation in the amount of active components here.

[Tim]

I think it is great that Dr. Stephen Kopecky mentions the fact that a patient can get a 3-month prescription of lovastatin for only $10. Some patients may think that red yeast rice capsules may be cheaper because they are a natural product, but that is not true. Patients will they have to pay more for the red yeast rice than lovastatin and will not even be able to be sure of exactly how much active ingredient they are taking or that they are ingesting any harmful contaminant toxins such as citrinin. I think the clear choice here for patients is to take the less expensive and safer choice: lovastatin. I feel confident making that recommendation to my patients.

[Jules]

I was definitely surprised to read that red yeast rice has the same chemical structure as lipid-lowering drugs like lovastatin. It's also difficult and somewhat disappointing to be someone in healthcare who is expected to recommend various products, when we are not even informed of the proportion of ingredients. I hope this will trigger stricter monitoring of OTC products in the future.

[China]

Generally, most herbal supplements, including the red yeast rice, lack standardization. But I am not convinced with the conclusion of the study based on only 12 red yeast rice products on the market. What kind of study design did they use? Who selected the products? Are the selected 12 products representing all types of red yeast rice available on the market? We need larger studies that include many products from different manufacturers.

[Vivian Chen]

Are there companies that do make standardized supplements that remain true to their labeling? Consumer Labs should make their own supplements!

[Taga]

It is sometimes scary to see that the FDA has no control over natural products. The manufacturing process of red yeast rice includes fermentation. The fermentation process, if not regulated properly, can cause toxins. People who are interested in taking these products should make sure to consult with their physicians and read the labels carefully before buying these products.

[AL]

Red yeast rice has been a popular alternative natural drug among hyperlipidemic patients who could not take statin drugs because of side effects like muscle pain. However, people should know that red yeast rice has the same active ingredient as some of the statin drugs, thus, it can cause similar side effects that are seen with statin drugs, including muscle pain.

People who are already taking statin drugs should be extra cautious about taking this supplement because the risk of experiencing side effects and toxic effects is high when used concurrently.

[MA]

I was interested just to learn that these monacolins in red yeast rice have the same structure as two statins, particularly in light of how many people in this country are on statins. I’m sure many would prefer to use a non-pharmaceutical alternative, even if just in combination with lower doses of statins, if they were aware of it. I wonder how much red yeast rice is equivalent to the recommended daily dose of a red yeast rice supplement, such as the ones discussed here.

I was also interested in the recommendation made by one of the physicians who was interviewed – that a combination of oat bran, plant sterols and stanols and psyllium seed may also serve as a non-pharmaceutical alternative to help lower cholesterol levels.

[IL]

There is another good study conducted on this topic.(http://www.ncbi.nlm.nih.gov/pubmed/11844656?dopt=Abstract) This study might be more helpful since it was done in an American population and used Cholestin®, which is the leading brand in the US market. The result of this study showed that Cholestin® showed significant reductions in LDL and total cholesterol, but there was no significant increase in HDL.

[SIH]

It is nice to see that the study showed the cholesterol-lowering effects of red yeast rice. However, people who are already taking prescription medications (HMG-CoA reductase inhibitors) for hyperlipidemia should be cautious in taking this supplement since red yeast rice has the same chemical structure as statin drugs.There is a case report that says that concurrent use of statin drugs and red yeast rice supplements may cause muscle pain.

[Vivian Chen]

I think both Dr. Gordon and Dr. Ulbricht make good points regarding the dangers of using red yeast rice if the ingredients are not standardized. This especially applies to patients who experience statin-related myalgia and myopathy who tend to seek natural and alternative ways to decrease their cholesterol levels.

[KL]

Interesting news story about the varying amounts of the active cholesterol-lowering drug in red yeast rice. It makes me wonder how many other products are out there that vary widely in content!!

[DER]

This news highlight is a good way to reiterate that herbs and supplements are not standardized. While many of them may be beneficial and safe, it is important to realize that you still must be careful about the products you buy.

[Carol]

This is very interesting to hear. I know many of my patients have asked about taking red yeast rice to help with cholesterol-lowering, especially before they try taking prescription medications. I'll now be able to bring this information into my practice to educate my patients.

[Ginnie]

Although I know that the actual amounts of herbs found in over-the-counter supplements are not required to be true and often vary, I am pretty shocked at the tiny amounts found in these red yeast rice capsules! It poses a dilemma to healthcare practitioners: How can we recommend natural products to someone if we have no idea how much active ingredient is in them? Red yeast rice is natural lovastatin, and thus could be very effective, but we need to know what doses our patients are taking!