Is Red Yeast Rice Safe?

Written by Dr. Steve Chaney on . Posted in Red Yeast Rice

Is Natural Always Better?

Author: Dr. Stephen Chaney

is red yeast rice safeIs red yeast rice safe?  First, let’s take a quick look at statins.

Statin drugs save lives. When taken by people who have survived a heart attack, they have proven effectiveness at lowering the risk of a second heart attack.

But, statins are also dangerous. They can cause muscle damage, liver damage, and even kidney failure (statin side effects ). Statins can also cause diabetes  and memory loss.

Because of these side effects, many people are looking for more natural alternatives for lowering their cholesterol. Many other people are unable to take the statin drugs because of muscle pain and/or elevated liver enzymes.

One popular alternative to statin drugs is red yeast rice. Red yeast rice comes from traditional Chinese medicine, so it is natural. However, just because a supplement is natural doesn’t necessarily mean that it is either safe or effective. Red yeast rice is a perfect example. Many people think that red yeast rice is as effective as statins for reducing cholesterol levels. They believe red yeast rice side effects are non‐existent. Nothing could be further from the truth!

Is Red Yeast Rice Safe and Effective?

Is Red Yeast Rice Effective?

is red yeast rice effectiveIs red yeast rice safe and effective.  The active ingredients in red yeast rice are a class of compounds called monacolins, which are close analogs of the statin drugs. In fact, the most abundant monacolin in red yeast rice, monacolin K, is identical to the statin drug lovastatin (Mevacor). That destroys one myth. If a red yeast rice product contains as much monacolin K as a lovastatin pill, it would have the same benefits and the same side effects.

It only gets worse! In fact, you have no way of knowing how much monacolin K is in your red yeast rice supplement. Because lovastatin is a drug, the manufacturers of red yeast rice are caught in a Catch‐22 situation. If the manufacturers were to actually standardize or disclose the levels of monacolin K in their product, the FDA would consider it an unapproved drug and remove it from the market.

When manufacturers don’t standardize their active ingredients, bad things happen.

How bad, you might ask? A recent study (RY Gordon, Archives of Internal Medicine, 170: 1722‐1727, 2010) analyzed the concentration of active ingredients in 12 commercially available red yeast rice supplements. The results were appalling:

  • Total monacolins in the supplements ranged from 0.31 to 11.15 mg/capsule.
  • Monacolin K (lovastatin) ranged from 0.10 to 10.09 mg/capsule.

To put that into perspective, therapeutic doses of lovastatin range from 10 to 80mg/day. Most of the red yeast rice supplements had an insignificant amount of monacolin K. Only a few of the samples tested had enough monacolin K to be equivalent to the lowest therapeutic dose of lovastatin.

 

Is Red Yeast Rice Safe?

is red yeast rice dangerousAnother study (Mazzanti et al, British Journal of Clinical Pharmacology, DOI:10.1111/bcp.13171) found that red yeast rice with 5-7 mg of monacolin K had the same frequency of side effects as 20-40 mg of pure, pharmaceutical grade lovastatin. The most frequent side effects were muscle pain, muscle damage, liver injury, gastrointestinal reactions, and skin reactions. Hospitalization was required in 25% of the cases.

It gets even worse! The first study (RY Gordon, Archives of Internal Medicine, 170: 1722‐1727, 2010) also measured levels of a toxin called citrinin that is produced by a fungus that grows on red yeast rice. Citrinin is potentially toxic to the kidneys. This is not a toxin that you would find in a pharmaceutical product like lovastatin, but it was present at high levels in one third of the red yeast rice formulations tested.

What Does This Mean For You?

Is red yeast rice safe?  To sum it all up, if you were to go out and purchase a red yeast rice supplement.

  • You might get a batch with no active ingredients. It wouldn’t have any of the side effects of a statin drug, but it wouldn’t have any efficacy either.
  • You might get a batch that would have the same efficacy and the same side effects as a low dose statin drug.
  • You would have a 33% chance of getting a batch that was contaminated with a toxin that you would never find in a statin drug—one that might damage your kidneys.

I don’t know about you, but after reading those studies I have no desire to ever try a red yeast rice supplement.

If you are looking for a natural cholesterol-lowering supplement that is both safe, effective, and recommended by the National Institutes of Health, choose one containing 2 grams of plant stanols and sterols.

Is red yeast rice safe?  Not always.

 

The Bottom Line

Just because a supplement is natural doesn’t necessarily mean that it is either safe or effective. Red yeast rice is a perfect example. Many people think that red yeast rice is as effective as statins for reducing cholesterol levels. They believe red yeast rice side effects are non‐existent. Nothing could be further from the truth!

  • The active ingredients in red yeast rice are a class of compounds called monacolins, which are close analogs of the statin drugs. In fact, the most abundant monacolin, monacolin K, is identical to the statin drug lovastatin (Mevacor).
  • There is no standardization of red yeast rice supplements. One study looked at 12 red yeast rice supplements and found that the dose of monacolin K ranged from almost nothing to the equivalent of the lowest therapeutic dose of lovastatin.
  • Another study found that the side effects of red yeast rice were identical in type and frequency to low dose lovastatin.
  • Even worse, one third of the red yeast rice supplements tested contained a toxin called citrinin that is potentially toxic to the kidneys.
  • To sum it all up, if you were to go out and purchase a red yeast rice supplement,
    • You might get a batch with no active ingredients. It wouldn’t have any of the side effects of a statin drug, but it wouldn’t have any efficacy either.
    • You might get a batch that would have the same efficacy and the same side effects as a low dose statin drug.
    • You would have a 33% chance of getting a batch that was contaminated with a toxin that you would never find in a statin drug—one that might damage your kidneys.

Natural isn’t always better! I don’t know about you, but after reading those studies I have no desire to ever try a red yeast rice supplement.

If you are looking for a natural cholesterol-lowering supplement that is both safe, effective, and recommended by the National Institutes of Health, choose one containing 2 grams of plant stanols and sterols.

 

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

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Do Omega-3s Lower Blood Pressure in Young, Healthy Adults?

Posted August 14, 2018 by Dr. Steve Chaney

What Is The Omega-3 Index And Why Is It Important?

Author: Dr. Stephen Chaney

 

Do omega-3s lower blood pressure in healthy adults?

omega-3s lower blood pressure young adultsThe literature on the potential health benefits of omega-3s is very confusing. That’s because a lot of bad studies have been published. Many of them never determined the omega-3 status of their subjects prior to omega-3 supplementation. Others relied on dietary recalls of fish consumption, which can be inaccurate.

Fortunately, a much more accurate measure of omega-3 status has been developed and validated in recent years. It’s called the Omega-3 Index. Simply put, the Omega-3 Index is the percentage of EPA and DHA compared to 26 other fatty acids found in cellular membranes. Using modern technology, it can be determined from a single finger prick blood sample. It is a very accurate reflection of omega-3 intake relative to other fats in the diet over the past few months. More importantly, it is a measure of the omega-3 content of your cell membranes, which is a direct measure of your omega-3 nutritional status.

A recent extension of the Framingham Heart Study reported that participants with an Omega-3 Index >6.8% had a 39% lower risk of cardiovascular disease than those with an Omega-3 Index <4.2% (WS Harris et al, Journal of Clinical Lipidology, 12: 718-724, 2018 ). Although more work needs to be done, an Omega-3 Index of 4% or less is generally considered indicative of high cardiovascular risk, while 8% or better is considered indicative of low cardiovascular risk. For reference, the average American has an Omega-3 Index in the 4-5% range. In Japan, where fish consumption is much higher and cardiovascular risk much lower, the Omega-3 Index is in the 9-11% range.

Previous studies have suggested that omega-3 fatty acids lower blood pressure to a modest extent. Thus, it is not surprising that more recent studies have shown an inverse correlation between Omega-3 Index and blood pressure. However, those studies have been done with older populations, many of whom had already developed high blood pressure.

From a public health point of view, it is much more interesting to investigate whether it might be possible to prevent high blood pressure in older adults by optimizing omega-3 intake in a young, healthy population, most of whom had not yet developed high blood pressure. Unfortunately, there were no studies looking at that population. The current study was designed to fill that gap.

 

How Was The Study Done?

omega-3s lower blood pressure young healthy adultsThe current study (M.G. Filipovic et al, Journal of Hypertension, 36: 1548-1554, 2018 ) was based on data collected from 2036 healthy adults, aged 25-41, from Liechtenstein. They were participants in the GAPP (Genetic and Phenotypic Determinants of Blood Pressure) study. Participants were excluded from the study if they had been diagnosed with high blood pressure and were taking medication to lower their blood pressure. They were also excluded if they had heart disease, chronic kidney disease, other severe illnesses, obesity, sleep apnea, or daily use of non-steroidal anti-inflammatory medications.

Blood samples were collected at the time of their enrollment in the study and frozen for subsequent determination of Omega-3 Index. Blood pressure was also measured at their time of enrollment in two different ways. The first was a standard blood pressure measurement in a doctor’s office.

For the second measurement they were given a wearable blood pressure monitor that recorded their blood pressure over 24 hours every 15 minutes during the day and every 30 minutes while they were sleeping. This is considered more accurate than a resting blood pressure measurement in a doctor’s office because it records the variation in blood pressure, while you are sleeping, while you are exercising, and while you go about your everyday activities.

 

Do Omega-3s Lower Blood Pressure In Young, Healthy Adults?

omega-3s lower blood pressure young adults equipmentNone of the participants in the study had significantly elevated blood pressure. The mean systolic and diastolic office blood pressures were 120±13 and 78±9 respectively. The average Omega-3 Index in this population was 4.6%, which is similar to the average Omega-3 Index in the United States.

When they compared the group with the highest Omega-3 Index (average = 5.8%) with the group with the lowest Omega-3 Index (average = 4.6%):

  • The office measurement of systolic and diastolic blood pressure was decreased by 3.3% and 2.6% respectively
  • While those numbers appear small, the differences were highly significant.
  • The 24-hour blood pressure measurements showed a similar decrease.
  • Blood pressure measurements decreased linearly with increasing Omega-3 Index. [In studies of this kind, a linear dose-response is considered an internal validation of the differences observed between the group with the highest Omega-3 Index and the group with the lowest Omega-3 Index.]

The authors concluded: “A higher Omega-3 Index is associated with statistically significant, clinically relevant, lower systolic and diastolic blood pressure in normotensive, young and healthy individuals. Diets rich omega-3 fatty acids may be a strategy for primary prevention of hypertension.”

 

What Does This Mean For You?

omega-3s lower blood pressure young adults questionPerhaps I should first comment on the significance of the relatively small decrease in blood pressure observed in this study.

  • These were young adults, all of whom had normal or near normal blood pressure.
  • The difference in Omega-3 Index was rather small (5.8% to 4.6%). None of the participants in the study were at the 8% or above that is considered optimal.
  • Liechtenstein is a small country located between Switzerland and Spain. Fish consumption is low and omega-3 supplement consumption is rare.

Under these conditions, even a small, but statistically significant, decrease in blood pressure is remarkable.

We should think of this study as the start of the investigation of the relationship between omega-3 status and blood pressure. Its weakness is that it only shows an association between high Omega-3 Index and low blood pressure. It does not prove cause and effect.

Its strength is that it is consistent with many other studies showing omega-3 fatty acids lower blood pressure. Furthermore, it suggests that the effect of omega-3s on blood pressure may also be seen in young, healthy adults who have not yet developed high blood pressure.

Finally, the authors suggested that a diet rich in omega-3s might reduce the incidence of high blood pressure by slowing the age-related increase in blood pressure that most Americans experience. This idea is logical, but speculative at present.

However, the GAPP study is designed to provide the answer to that question. It is a long-term study with follow-up examinations scheduled every 3-5 years. It will be interesting to see whether the author’s prediction holds true, and a higher Omega-3 Index is associated with a slower increase in blood pressure as the participants age.

 

Why Is The Omega-3 Index Important?

 

The authors of this study said: “The Omega-3 Index is very robust to short-term intake of omega-3 fatty acids and reliably reflects an individual’s long-term omega-3 status and tissue omega-3 content. Therefore, the Omega-3 Index has the potential to become a cardiovascular risk factor as much as the HbA1c is for people with diabetes…” That is a bit of an overstatement. HbA1c is a measure of disease progression for diabetes because it is a direct measure of blood sugar control.

In contrast, Omega-3 Index is merely a risk factor for cardiovascular disease. However, if it is further validated by future studies, it is likely to be as important for predicting cardiovascular risk as are cholesterol levels and markers of inflammation.

However, to me the most important role of Omega-3 Index is in the design of future clinical studies. If anyone really wants to determine whether omega-3 supplementation reduces cardiovascular risk, high blood pressure, diabetes or any other health outcome they should:

  • Start with a population group with an Omega-3 Index in the deficient (4-5%) range.
  • Supplement with omega-3 fatty acids in a double blind, placebo-controlled manner.
  • Show that supplementation brought participants up to an optimal Omega-3 Index of 8% or greater.
  • Look at health outcomes such as heart attacks, cardiovascular deaths, hypertension, stroke, or depression.
  • Continue the study long enough for the beneficial effects of omega-3 supplementation to be measurable. For cardiovascular outcomes the American Heart Association has stated that at least two years are required to obtain meaningful results.

These are the kind of experiments that will be required to give definitive, reproducible results and resolve the confusion about the health effects of omega-3 fatty acids.

 

The Bottom Line

 

An accurate measure of omega-3 status has been developed and validated in recent years. It’s called the Omega-3 Index. Simply put, the Omega-3 Index is the percentage of EPA and DHA compared to 26 other fatty acids found in cellular membranes.

Although more work needs to be done, an Omega-3 Index of 4% or less is generally considered indicative of high cardiovascular risk while 8% or better is considered indicative of low cardiovascular risk.

Previous studies have shown an inverse correlation between Omega-3 Index and blood pressure. However, these studies have been done with older populations, many of whom had already developed high blood pressure.

From a public health point of view, it is much more interesting to investigate whether it might be possible to prevent high blood pressure in older adults by optimizing omega-3 intake in a young, healthy population, most of whom had not yet developed high blood pressure. Until now, there have been no studies looking at that population.

The study described in this article was designed to fill that gap. The participants in this study were ages 25-41, were healthy, and none of them had elevated blood pressure.

When the group with the highest Omega-3 Index (average = 5.8%) was compared with the group with the lowest Omega-3 Index (average = 4.6%):

  • Both systolic and diastolic blood pressure were decreased
  • Blood pressure measurements decreased linearly with increasing Omega-3 Index.

The authors concluded: “A higher Omega-3 Index is associated with statistically significant, clinically relevant, lower systolic and diastolic blood pressure in normotensive, young and healthy individuals. Diets rich omega-3 fatty acids may be a strategy for primary prevention of hypertension.”

Let me translate that last sentence into plain English for you. The authors were saying that optimizing omega-3 intake in young adults may slow the age-related increase in blood pressure and reduce the risk of them developing high blood pressure as they age. This may begin to answer the question “Do omega-3s lower blood pressure in young, healthy adults?”

Or even more simply put: Aging is inevitable. Becoming unhealthy is not.

For more details, read the article above.

 

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

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