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The Supplement Lipitor Does Not Want YOU to Know About

Red yeast rice occupies the thin line between drug and dietary supplement. It contains monacolins which are identical to prescription statin drugs used to lower cholesterol. Although red yeast rice has been repeatedly proven to lower cholesterol, they also share the side effects of statins. Therefore, there are concerns that they may do more harm than good if left unregulated. This article discusses the efficacy and safety of red yeast rice and also compares it to statins.
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What is Red Yeast Rice?

Red yeast rice, also known as red fermented rice and red koji rice, is a bright red purple fermented rice commonly used in Asian cuisine and Chinese traditional medicine.

Red yeast rice is cultivated with the mold, Monascus purpurea, which gives it a bright red purple color.

This mold is traditionally used in the production of fermented foods in China. However, following the discovery of the medicinal uses of red yeast rice, there has been a great interest in using the microbe to produce statins (a class of cholesterol-lowering agents also found in red yeast rice).

Red yeast rice is used as a food coloring agent in Asian cuisine. It can impact its red purple color to a variety of foods including tofu and rice wine. Red yeast rice is also used to enhance food taste.

In traditional Chinese medicine, red yeast rice is used in the treatment of indigestion and diarrhea. It is also used to improve blood circulation and to detoxify the body.

However, the medicinal properties (especially the cholesterol-lowering ability) of red yeast rice caught the interest of researchers in the 1970s when they isolated a group of phytochemicals known as monacolins from molds in the Monascus species.

Monacolins are essentially statins and, of the eight monacolins isolated from Monascus purpurea, monacolin K is the most popular member of the group.

In fact, researchers have shown that monacolin K is identical to lovastatin.

Because red yeast rice is rich in monacolin K, it shares most of the medicinal properties and side effects of statins. However, studies show that the dose of red yeast rice supplements needed to reduce cholesterol levels is lower than the required doses of statin drugs.

In addition, red yeast rice contains other phytochemicals besides statins (monacolins). For example, it is also rich in phytosterols.

Overall, red yeast rice supplements represent a viable alternative to expensive and widely prescribed statin drugs. Therefore, manufacturers of statin drugs, like Pfizer’s Lipitor (atorvastatin) and Merck’s Mevacor (lovastatin), would prefer that patients do not know about this effective and affordable alternative.

Over the years, red yeast rice supplements have been the subject of repeated regulation by the Food and Drug Administration (FDA). In fact, the FDA classifies red yeast rice supplements with appreciable monacolin content as drugs.

What Is In Red Yeast Rice?
  • Rice starch
  • Fiber
  • Protein
  • Ash
  • Phosphorus, calcium, aluminum, iron, copper, magnesium, manganese and silver
  • Monacolin K, Monacolin I – VI and Dihydromonacolin
  • Palmitic acid, Stearic acid, Oleic acid, Linoleic acid and Linolenic acid

Red Yeast Rice and Cholesterol

How Statins Lower Cholesterol

The major mechanism by which red yeast rice lowers cholesterol is by inhibiting cholesterol synthesis in the liver. This is also how statins lower cholesterol levels.

To block the production of cholesterol in the liver, the statins in red yeast rice (mostly monacolin K or lovastatin) inhibit the enzyme, HMG-CoA reductase. HMG-CoA reductase is important to the mevalonate pathway that produces cholesterol, other sterols and related compounds.

When its actions are blocked, more receptors for LDL (low-density lipoprotein or “bad”) cholesterol are produced in the liver and, therefore, more LDL cholesterol is removed from the plasma to be broken down in the liver.

Therefore, red yeast rice and the other inhibitors of HMG-CoA reductase reduce the levels of total cholesterol and LDL cholesterol by this means.

However, the mevalonate pathway is responsible for the production of other essential compounds in the body. The muscle and liver damage caused by statins can be traced to the other compounds blocked by the inhibition of the HMG-CoA and the mevalonate pathway.

This means that the risk of muscle and liver damage is also present with red yeast rice supplementation.

Experts recommend that those taking red yeast rice supplements should have their liver function checked periodically.

It is worth noting that the results of clinical trials show that red yeast rice supplements cause milder and less frequent side effects than statins. This is because these supplements contain lower doses of statins when compared to prescription statin drugs.

On the other hand, studies show that the cholesterol-lowering effect of red yeast rice supplement is comparable to prescription statin drugs.

Can Red Yeast Rice Lower Cholesterol Levels?

In one study published in 2009 in the Annals of Internal Medicine, a group of patients were given 1,800 mg/day of red yeast rice supplement for 12 weeks. This supplementation was coupled with dietary changes and exercise.

The results of the study showed that red yeast rice supplementation lowered LDL cholesterol by 27% while diet and exercise only reduced LDL cholesterol by 6% in the placebo group.

The researchers noted that a marked reduction in LDL cholesterol like this can only be obtained with considerably higher doses of prescription statins.

Red Yeast Rice for Lowering Cholesterol Levels

The 2009 study published in the Annals of Internal Medicine concluded that red yeast rice

  • Significantly lowered LDL cholesterol and total cholesterol levels
  • Did not cause weight loss or affect HDL cholesterol level
  • Did not affect liver or muscle enzymes and did not cause muscle pain (unlike statins)

This remarkable cholesterol-lowering effect (compared to statins) is the main reason researchers are convinced that the hypocholesterolemic effect of red yeast rice is not solely due to its statin content.

The presence of other cholesterol-lowering compound in red yeast rice is good news because the FDA mandates manufacturers to remove statin-like monacolins from red yeast rice supplements sold in the US.

More Studies on Red Yeast Rice and Cholesterol

Red Yeast Rice, Cholesterol and Triacylglycerol

A 1999 study published in the American Journal of Clinical Nutrition also confirmed the cholesterol-lowering properties of red yeast rice.

The researchers recruited 83 adults with hyperlipidemia who were not currently taking lipid-lowering drugs. These participants were then given either placebo or 2.4 g/day of red yeast rice for 12 weeks.

At the end of the study period, the results showed that total cholesterol and LDL cholesterol levels as well as triacylglycerol level were significantly reduced in the participants who received red yeast rice. HDL cholesterol level was, however, not unaffected.

The researchers, therefore, recommended red yeast rice as a dietary intervention for reducing cholesterol levels even before lipid-lowering drugs are considered.

A 1998 study published in the journal, Nutrition Research, also reached the same conclusions. This study involved animal models fed high-cholesterol diets.

In all the animal models used in the study, red yeast rice reduced both total cholesterol and triglyceride levels while also suppressing arteriosclerosis caused by fatty diets.

Red Yeast Rice vs. Lovastatin

In a 2003 study published in The Journal of Nutritional Biochemistry, a group of researchers compared the hypocholesterolemic effects of red yeast rice and lovastatin in rabbits.

The rabbits were placed on a cholesterol diet for 200 days and divided into 4 groups.

One group remained on the diet and served as the control group. The rabbits in the next 2 groups received either 0.4 or 1.35 g/kg/day of Cholestin, a red yeast rice supplement. The rabbits in the 4th group were given 0.0024 g/kg/day lovastatin.

The study results showed that serum total cholesterol, LDL cholesterol and triglyceride levels were reduced in all the rabbits receiving red yeast rice and lovastatin.

However, only the red yeast rice treatment lowered atherosclerotic index. This index is the ratio of non-HDL cholesterol to HDL cholesterol. The result suggests that red yeast rice also reduced the serum levels of other non-HDL cholesterols besides LDL cholesterol.

Upon examination, the researchers found that red yeast rice did reduce the severity of atherosclerosis a lot more than lovastatin.

This study showed that although lovastatin and red yeast rice share similar hypocholesterolemic benefits, the latter can provide additional benefits to improve cardiovascular health.

The most likely explanation for these results is that red yeast rice should not be equated with statins because it contains other bioactive compounds that can lower cholesterol levels and prevent the thickening of the arteries.

Multi-Center Study

One of the criticisms of the 2009 study published in the Annals of Internal Medicine, is that it is a small, single-site study. However, an earlier study published in the journal, Current Therapeutic Research, in 1997 did pool over 400 patients from different centers in China.

Over the course of 8 weeks, the researchers gave a red yeast rice supplement (Cholestin) to 324 participants and a Chinese herb, Jiaogulan to 122 participants serving as positive control.

The results of the study showed that red yeast rice

  • reduced total cholesterol by 22.7% (compared to 7% in the control group)
  • reduced LDL cholesterol by 30.9% (compared to 8.3% in the control group)
  • reduced serum triglycerides by 34.1% (compared to 12.8% in the control group)
  • increased HDL cholesterol by 19.9% (compared to 8.4% in the control group)

The researchers concluded that red yeast rice was a very effective dietary supplement for improving lipid profile and cardiovascular health.

Review and Meta-Analysis of Past Studies

A 2004 paper published in the journal, Life Sciences, reviewed the body of evidence supporting the use of red yeast rice for lowering cholesterol levels.

The authors summarized that there was a strong and clear clinical support to indicate that red yeast rice can moderately lower cholesterol levels and serve as alternatives to statin drugs. In addition, they highlighted the fact that red yeast rice caused fewer side effects that cholesterol-lowering drugs.

In conclusion, the authors suggested deeper exploration of similar pigmented rice products as a new class of drugs that are also functional foods.

A 2006 review published in the journal, Chinese Medicine, provided a meta-analysis of 93 randomized clinical trials (involving over 9,000 participants) done to investigate the cholesterol-lowering properties of red yeast rice.

These studies were taken from reputable repositories of peer-reviewed clinical studies such as PubMed and the Cochrane Library.

This review made the following conclusions:

  • Red yeast rice can lower total cholesterol, LDL cholesterol and triglyceride levels as well as increase HDL cholesterol levels compared to placebo
  • Red yeast rice lowers cholesterol levels much in the same way as statins and to similar extents
  • Red yeast rice has a superior cholesterol-lowering effect than fish oils and nicotinate
  • Only mild side effects were associated with red yeast rice supplementation. The most common of these side effects are dizziness and gastrointestinal discomfort

The reviewers concluded that current evidence support short-term use of red yeast rice supplements. They also called for longer studies to investigate the long-term efficacy and safety of red yeast rice.

Red Yeast Rice Supplements: Safety and FDA Regulations

Currently, the FDA considers red yeast rice supplements that contain more than trace amounts of monacolin K as drugs that can be regulated. This also means that red yeast rice supplement cannot be marketed for their statin or monacolin content. They also cannot be recommended for lowering cholesterol.

All of these restrictions mean that manufacturers who wish to sell red yeast rice as dietary supplement do not standardize the monacolin content of these supplements. This is done so that the FDA does not classify these supplements as drugs.

In fact, red yeast rice supplements sold in the US are not meant to contain statins or monacolins.

However, the reality is that the monacolin content of the red yeast rice supplements on the market varies widely even though manufacturers are forced to remove statins from their products.

The first ban on a red yeast rice was in 1998 when the FDA moved to ban Cholestin. However, the decision was reversed in 2001 and by 2003, red yeast rice supplements were back in the US. Even though the FDA sent warning letters to some manufacturers in 1997, red yeast rice supplements are still on the market and, presently, there are over 30 different brands on the supplement.

Because red yeast rice can indeed lower cholesterol much in the same way as statins, some critics warn that it causes the same side effects as statins. These side effects include liver, kidney and muscle damage.

Even though there are reports that red yeast rice supplements can cause liver damage and muscle pain, these side effects are not as common as they are for prescription statin drugs. One reason for this is that red yeast rice supplements contain lower doses of statins than prescription statin drugs.

In addition, experts believe that there are other phytochemicals in red yeast rice responsible for its cholesterol-lowering properties.

Impurities are the other concerns about the safety of red yeast rice supplements. In the past, some red yeast rice supplements were found to contain significant amounts of citrinin, a known toxin.

In spite of the FDA insistence on removing the statins in red yeast supplements, a few manufacturers have been known to add purified lovastatin to their products. This was done to improve the cholesterol-lowering potencies of their red yeast rice brands.

Because of all of these concerns, choosing the right brand of red yeast supplement is important.





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