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Omega-3s During Pregnancy Are Healthy

October 2, 2019October 1, 2019 by Dr. Steve Chaney

It’s Definite: Omega-3s Reduce Preterm Births

Author: Dr. Stephen Chaney

The role of omega-3s on a healthy pregnancy has been in the news for some time. Claims have been made that omega-3s reduce preterm births, postnatal depression, and improve cognition, IQ, vision, mental focus, language and behavior in the newborn as they grow.

The problem is that almost all these claims have been called into question by other studies. If you are pregnant or thinking of becoming pregnant, you don’t know what to believe.

Should you eat more fish?
Should you take omega-3 supplements?
Or should you just ignore the claims about omega-3s and a healthy pregnancy?

Omega-3s during pregnancy is healthy or not? These are not trivial questions. Let’s consider preterm births as an example. The medical profession has made enormous advances in keeping premature babies alive. However, premature babies are still at higher risk of several health conditions including:

Visual impairment.
Developmental Delay.
Learning difficulties.

Plus, it is expensive to keep premature babies alive. One recent study estimated that increasing omega-3 intake during pregnancy could reduce health care costs by around $6 billion in the United Stated alone.

Unfortunately, it’s not just omega-3s and pregnancy. The same is true for almost all nutritional health claims. One day a study comes out claiming that nutrient “X” cures some disease or has some miraculous benefit. The bloggers and news media hype that study. Suddenly you see that health claim everywhere. It becomes so omnipresent that you are tempted to believe it must be true.

But, wait. A few months later another study comes to an opposite conclusion. Now the media is telling you that health claim is false. The months come and go, and new studies keep coming out. Some support the health claim. Others refute it.

Pretty soon the nutrition headlines just become “noise.” You don’t know what to believe. If you want the truth, “Who ya gonna call?”

Who Ya Gonna Call?

It’s not Ghostbusters. It not Dr. Strangelove’s health blog. It’s a group called the Cochrane Collaboration.

The Cochrane Collaboration consists of 30,000 volunteer scientific experts from across the globe whose sole mission is to analyze the scientific literature and publish reviews of health claims so that health professionals, patients, and policy makers can make evidence-based choices about health interventions.

The Cochrane Collaboration reviews all the relevant studies on a topic, exclude those that are biased or weak, and make their recommendations based on only the strongest studies. Their reviews are considered the gold standard of evidence-based medicine.

If you are of a certain age, you may remember that TV commercial “When EF Hutton talks, people listen.” It is the same with the Cochrane Collaboration. When they talk, health professionals listen.

This week we will examine the Cochrane Collaboration’s review titled “Omega-3 Fatty Acid Addition During Pregnancy.”

How Was The Study Done?

For this analysis the Cochrane Collaboration reviewed 70 randomized controlled trials which compared the effect of added omega-3s on pregnancy outcomes with the effect of either a placebo or no omega-3s. These trials included almost 19,927 pregnant women.

In one sense, Cochrane reviews are what is called a “meta-analysis”, in which data from numerous studies are grouped together so that a statistically significant conclusion can be reached. However, Cochrane Collaboration reviews differ from most meta-analyses found in the scientific literature in a very significant way.

Many published meta-analyses simply report “statistically significant” conclusions. However, statistics can be misleading. As Mark Twain said: “There are lies. There are damn lies. And then there are statistics.”

The problem is that the authors of most meta-analyses group studies together without giving sufficient consideration to the quality of studies included in their analysis. This creates a “Garbage In – Garbage Out” effect. If the quality of individual studies is low, the quality of the meta-analysis will also be low. Simply put, the conclusions from some published meta-analyses are not worth the paper they are written on.

The Cochrane Collaboration also reports statistically significant conclusions from their meta-analyses. However, they also carefully consider the quality of each individual study in their analysis. They look at possible sources of bias. They look at the design and size of the studies. Finally, they ask whether the conclusions are consistent from one study to the next. They clearly define the quality of evidence that backs up each of their conclusions as follows:

High-quality evidence. Further research is unlikely to change their conclusion. This is generally reserved for conclusions backed by multiple high-quality studies that have all come to the same conclusion. These are the recommendations that are most often adopted into medical practice.
Moderate-quality evidence. This conclusion is likely to be true, but further research could have an impact on it.
Low-quality evidence. Further research is needed and could alter the conclusion. They are not judging whether the conclusion is true or false. They are simply saying more research is needed to reach a definite conclusion.

It’s Definite: Omega-3s During Pregnancy is Healthy

Here are the conclusions that the Cochrane Collaboration said were supported by high-quality evidence:

Omega-3s reduce the risk of preterm births.
Omega-3s reduce the risk of low birth weight infants.

The authors concluded: “Omega-3 supplementation during pregnancy is an effective strategy for reducing the risk of preterm birth…More studies comparing [the effect of] omega-3s and placebo [on preterm births] are not needed at this point.”

In other words, they are saying this conclusion is definite. Omega-3 supplementation should become part of the standard of medical care for pregnant women.

However, they did say that further studies were needed “…to establish if, and how, outcomes vary by different types of omega-3s, timing [stage of pregnancy], doses [of omega-3s], or by characteristics of women.”

That’s because these variables were not analyzed in this study. The study included clinical trials:

Of women at low, moderate, and high risk of poor pregnancy outcomes.
With DHA alone, with EPA alone, and with a mixture of both.
Omega-3 doses that were low (˂ 500 mg/day), moderate (500-1,000 mg/day), and high (> 1,000 mg/day).

Do Omega-3s Make For A Healthy Pregnancy?

What about the effect of omega-3s on other pregnancy outcomes?

The conclusions the Cochrane Collaboration said were supported by moderate quality evidence included reductions in:

Perinatal death.
Admissions to the neonatal intensive care unit.

There was not enough high or moderate quality data to determine the effect of omega-3s on other pregnancy outcomes such as postnatal depression. More research is still needed in those areas. However, if they do occur, you can just consider them as side benefits.

What Does This Report Mean For You?

The proven effect of omega-3 supplementation on preterm births is significant because preterm births increase the risk of:

Visual impairment.
Developmental Delay.
Learning difficulties.

The likely effect of omega-3s on admission to neonatal intensive care units is significant because those units are very expensive.

One recent study concluded that omega-3 supplementation during pregnancy might save the US health care system $6 billion per year.

This study did not determine whether omega-3 supplementation was equally important for women at low, moderate, and high likelihood of poor pregnancy outcomes.

Therefore, omega-3 supplementation should be considered for all pregnant women.

This study did not determine whether omega-3 supplementation was equally important during the first, second, or third trimester.

Therefore, omega-3 supplementation should be considered by all women of childbearing age who might become pregnant.

This study did not determine whether DHA, EPA, or a mixture of the two was most effective.

Therefore, your omega-3 supplement should probably contain both DHA and EPA. A group of experts recently recommended that adults consume at least 650 mg/day of omega-3s with 220 mg of that coming from DHA and 220 mg/day coming from EPA.

This study did not determine the minimum effective dose of omega-3s to reduce preterm births.

Most health organizations recommend that pregnant women consume between 200-500 mg/day of omega-3s.
For example, one group of experts recently recommended pregnant women consume at least 300 mg/day of DHA and 220 mg/day of EPA.
The American College of Obstetrics and Gynecology recommends supplementation with 200 mg/day of DHA. However, that recommendation assumes that the increase will come from fish and was influenced by concerns that omega-3-rich fish are highly contaminated with heavy metals and PCBs.
Since most pregnant women in this country consume around 89 mg/day of DHA + EPA, some degree of omega-3 supplementation in the 200-500 mg/day range is warranted.

The Bottom Line

The effect of omega-3s on pregnancy outcomes have been confusing. Some studies conclude that omega-3s during pregnancy is healthy. Other studies suggest they are ineffective. What are you to believe?

Fortunately, a group called the Cochrane Collaboration recently conducted a comprehensive review of this topic. This is significant because Cochrane Reviews are internationally recognized as the highest standard in evidence-based health care. They influence the treatment protocols recommended by the medical community.

This Cochrane Review concluded that omega-3 supplementation during pregnancy:

Reduces preterm births and low birth weight infants.
Likely reduces perinatal death and admissions to the neonatal intensive care unit.

The authors of the review said: “Omega-3 supplementation during pregnancy is an effective strategy for reducing the risk of preterm birth…More studies comparing [the effect of] omega-3s and placebo [on preterm births] are not needed at this point.”

In other words, they are saying this conclusion is definite. Omega-3 supplementation should become part of the standard of medical care for pregnant women.

This study did not determine the minimum effective dose of omega-3s to reduce preterm births.

Most health organizations recommend that pregnant women consume between 200-500 mg/day of omega-3s.
Since most pregnant women in this country consume around 89 mg/day of DHA + EPA, some degree of omega-3 supplementation is warranted.

For more details on the study and what it means for you, 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.

How Much Omega-3s Do You Need?

March 5, 2019 by Dr. Steve Chaney

Can You Get The Omega-3s You Need From Diet Alone?

Author: Dr. Stephen Chaney

Two recent studies have provided strong evidence that omega-3s reduce the risk of heart attacks. However, both studies used high doses of omega-3s and did not do a dose-response analysis. That leaves you with several unanswered questions:

How much omega-3s do you need to significantly reduce your risk of heart attack?
Will that amount of omega-3s provide other health benefits?
Can you get that amount of omega-3s from diet alone?
Can you get that amount of omega-3s from supplementation alone?

Fortunately, a recent study (KH Jackson et al, Prostaglandins, Leukotrienes and Essential Amino Acids, 142: 4-10, 2019) has answered those questions. But, before we consider that article, we should look at a biomarker called “Omega-3 Index.”

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

The Omega-3 Index is a measure of the ratio between the heart-healthy omega-3 fats (EPA + DHA) and all the other fats in red blood cell membranes. It is considered an excellent measure of our omega-3 status.

Dr. William S Harris, one of the top experts in the omega-3 field, first proposed the Omega-3 Index as a biomarker for cardiac health back in 2007. Based on multiple clinical and population studies, he proposed that an Omega 3 Index of 4% was associated with high heart attack risk, and an Omega-3 Index of 8% was associated with low heart attack risk. This has been supported by a recent meta-analysis of 10 clinical studies showing that an Omega-3 Index of 8% was associated with a 35% reduction in cardiovascular death compared to an Omega-3 Index of 4%.

Other studies suggest that an Omega-3 Index of 8% is associated with:

A slower rate of telomere shortening.
A lower risk of death from any cause.
Reduction in symptoms of depression.
Improved recovery from a heart attack.
Reduction in arthritis symptoms.
Reduced age-related brain shrinkage in B-vitamin treated subjects. (I have written about the synergistic relationship between omega-3s and B vitamins with respect to brain health in a previous issue of “Health Tips From the Professor.”

(Note: You will find references to these studies in the paper I have cited.)

For reference, most Americans have an Omega-3 Index between 4 and 6%. In contrast, in Japan, where the incidence of heart disease is much lower, the Omega-3 Index ranges from 6.8% to 9%.

How Was The Study Designed?

The data for this study were derived from 3458 individuals who 1) sent in a dried blood spot to a commercial laboratory for determination of Omega-3 Index between March 30, 2017 and January 15, 2018, 2) filled out a short questionnaire about fish intake and omega-3 supplement use, and 3) were older than 18.

With respect to fish intake, the possible responses were “none per week,” “every other week,” “every week,” “2 times per week,” and “3 or more times per week.”

With respect to omega-3 supplement use, those who reported taking an omega-3 supplement were asked what kind of omega-3 supplement they were taking. Those who said they were taking a flaxseed oil supplement were excluded from the analysis because flaxseed oil contains no EPA or DHA.

The characteristics of the population studied were as follows:

84% came from the United States. The remaining 16% came from 27 other countries.
The average age was 51 years and 40% of the respondents were male.
62% ate little or no fish. The exact breakdown of fish consumption was:
- 5% ate no fish.
- 9% ate fish every other week.
- 6% ate fish weekly.
- 2% ate fish twice a week.
- 8% ate fish three or more times a week.

52% took omega-3 supplements. Of those taking omega-3 supplements, 84% were taking fish oil supplements.

How Much Omega-3s Do You Need?

The correlation between omega-3 intake and Omega-3 Index in these individuals was:

No fish = 4.5%.
- No fish + supplementation = 6.6%.

Bi-weekly = 4.8%
- Bi-weekly + supplementation = 6.9%

Weekly = 5.1%
- Weekly + supplementation = 7.3%

Twice weekly = 5.7%
- Twice weekly + supplementation = 7.8%

3+ times per week = 6.5%
- 3+ times per week + supplementation = 8.6%

The authors said: “We found that those with the best chance of achieving a desirable Omega-3 Index were reporting the consumption of at least 3 fish meals per week and were taking an EPA + DHA-containing omega-3 supplement.”

The authors further concluded that an EPA + DHA intake of around 835 mg per day or higher would be required to achieve an average Omega-3 Index of 8%. This was based on two assumptions:

A 4 once serving of oily fish provides around 1,200 mg of EPA + DHA.
The average omega-3 supplement provides around 300 mg of EPA + DHA.

What Are The Limitations Of The Study?

The two biggest limitations of the study are the assumptions that a serving of fish provides 1,200 mg of EPA + DHA and a fish oil supplement provides 300 mg of EPA + DHA.

Their dietary survey did not ask what kind of fish the respondents were consuming. Some fish provide much less than 1,200 mg of EPA + DHA per serving. This could have caused the authors to overestimate the contribution that fish intake made to the Omega-3 Index in their study.
Some omega-3 supplements provide more than 300 mg EPA + DHA, and some people take more than the recommended number of omega-3 capsules. This could have caused the authors to underestimate the contribution of omega-3 supplements to the Omega-3 Index in their study.

The major implication of these limitations comes when we look at the standard deviation of the correlations between omega-3 intake and Omega-3 Index.

Some people consuming 3 or more servings of fish per week had an Omega-3 Index of well above 8%. This suggests that diet alone can allow you to reach an optimal Omega-3 Index. This conclusion is also supported by dietary studies in Japan (see below).
Some people taking omega-3 supplements had an omega-3 index of above 8% even in the group consuming no fish. This suggests that supplementation alone can allow you to reach an optimal Omega-3 Index as long as your total EPA + DHA intake is 835 mg/day or greater.

These limitations may also affect the calculation of how much EPA + DHA we need to reach an optimal Omega-3 Index. For example, the most widely used omega-3 calculator estimates that you would need 950 mg of EPA + DHA to increase your Omega-3 Index from 4% to 8%.

What Does This Study Mean For You?

At the beginning of this article I said that this study answered 4 questions:

How much omega-3s do you need to significantly reduce your risk of heart attack?
- This study estimated that around 835 mg/day of EPA + DHA is needed to reach an Omega-3 Index of 8%, which previous studies have shown to be associated with low heart disease risk.
- This is similar to the 950 mg/day estimate from a widely used omega-3 calculator.
- There is considerable individual variability, but 835 – 950 mg/day is a good target for most people. If in doubt, I recommend that you get your Omega-3 Index tested.

Will that amount of omega-3s provide other health benefits?
- The evidence is strongest for heart health, but this paper lists other studies suggesting that a high Omega-3 Index is associated with reduced risk of depression, arthritis, age-related brain shrinkage & cognitive decline, and death from all causes.

Can you get that amount of omega-3s from diet alone?
- In this study an optimal Omega-3 Index was achieved only in the group that consumed 3 or more servings of fish per week and took an omega-3 supplement. However, not all those fish were rich in EPA + DHA.
- Previous studies have shown that Japanese who consume 3 or more servings per week of oily fish, rich in EPA + DHA, have an Omega-3 Index of 6.8% to 9%. This shows us it is possible to reach an optimal Omega-3 Index from diet alone.

Can you get that amount of omega-3s from supplementation alone?
- Here the answer is clearly yes. Based on this and other studies, it would require in the range of 835-950 mg/day from supplementation to reach an optimal Omega-3 Index for most people.

Here are some other conclusions from the authors of the study:

“The average Omega3 Index in Japan ranges from 6.8 to 9.0%…So, yes, an Omega-3 Index of >8% is achievable by diet alone. But Japan is fairly unique…The average Omega-3 Index for Americans ranges from 4 to 6%. So, short of adopting the Japanese diet for a lifetime, it appears that taking an EPA + DHA supplement could be an important strategy for achieving a cardioprotective Omega-3 Index.”
They consider current recommendations for omega-3 intake to be inadequate. Their recommended intake of 835 mg of EPA + DHA per day is:
- “>3 times the EPA + DHA recommended by the Dietary Guidelines for Americans (250 mg/day).”
- “1.7 times the amount recommended by the Academy of Nutrition and Dietetics (500 mg/day).”
- “8 times higher than the typical EPA + DHA intake in the US (~100 mg/day).”
The American Heart Association currently recommends the consumption of 1-2 seafood meals per week.
The authors commented: “We do recognize that public health recommendations must balance what is ideal vs. what is practical for the public and must also take into consideration…potentially hazardous components of fish (mercury, PCBs) and the sustainability of the world’s fish supply.”
However, they considered the recommendation of the American Heart Association to be woefully inadequate. Based on their data, they concluded: “To achieve an Omega-3 Index of >8%, either adding an EPA + DHA supplement or increasing to 4-5 servings of fish/week would be necessary.”

Because of the high level of contamination of the world’s fish supply, my personal preference would be to add a high purity omega-3 supplement to my diet rather than consuming fish multiple times a week. I love salmon, but I try to limit myself to a salmon dinner no more than once a month.

The Bottom Line

A recent study looked at how much EPA + DHA you would need to achieve an optimal omega-3 status. The investigators used a measurement called Omega-3 Index, which has been shown to be an excellent measurement of omega-3 status. They asked how much EPA + DHA from diet plus supplementation was required to achieve an Omega-3 Index of 8%, which is associated with a low risk for heart disease. The key findings from this study were:

Around 835 mg/day of EPA + DHA is needed to reach an Omega-3 Index of 8%.
This is similar to the 950 mg/day estimate from a widely used omega-3 calculator.
There is considerable individual variability, but 835 – 950 mg/day is a good target for most people. If in doubt, I recommend that you get your Omega-3 Index tested.
The Japanese eat EPA + DHA-rich fish 3 or more times per week and have an Omega-3 Index of 6.9 to 9.0%, so it is clearly possible to achieve an optimal Omega-3 Index from diet alone. However, the American diet is so different from the Japanese diet that the authors concluded: “Short of adopting the Japanese diet for a lifetime, it appears that taking an EPA + DHA supplement could be an important strategy for achieving a cardioprotective Omega-3 Index.”
The American Heart Association currently recommends the consumption of 1-2 seafood meals/week. The authors consider this recommendation to be woefully inadequate. They said: “To achieve an Omega-3 Index of >8%, either adding an EPA + DHA supplement or increasing to 4-5 servings of fish/week would be necessary.”

Because of the high level of contamination of the world’s fish supply, my personal preference is to add a high purity omega-3 supplement to my diet rather than consuming fish multiple times a week. I love salmon, but I try to limit myself to a salmon dinner no more than once a month.

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.

Are Omega-3 Supplements Good For You?

December 4, 2018 by Dr. Steve Chaney

Do Omega-3s Reduce Risk Of Heart Disease & Cancer?

Author: Dr. Stephen Chaney

Are omega-3 supplements good for you?

You have every right to be confused. In the late 1990s and early 2000s several major clinical studies showed that omega-3 supplements reduced the risk of heart attacks and stroke. In contrast, a few months ago a major study called ASCEND was published that failed to find any benefit of omega-3s at reducing heart disease risk. The headlines said “Omega-3 Supplements Don’t Protect Against Heart Disease”. You were told that omega-3 supplements were worthless. I pointed out the weakness of that study in a previous issue of “Health Tips From the Professor”.

In mid-November two more major clinical studies were published. However, if you rely on the media for your information on supplementation, you are probably still confused. Headlines ranged from “Omega-3 Supplements Do Not Prevent Cancer Or Heart Disease” to “Eating More Fish Or Taking Omega-3 Fish Oil Supplements Can Cut Heart Attack Risk.” What is the truth?

The problem is that reporters aren’t scientists. They don’t know how to interpret clinical studies. What they report is filtered through their personal biases. That is why I take the time to carefully evaluate the clinical studies, so I can provide you with accurate information. Let me sort through the dueling headlines and give you the truth about omega-3s.

Note: One of the clinical studies looked at the effect of omega-3s on both cancer and heart disease risk. I will discuss the cancer results briefly, but most of my focus will be on the heart disease findings.

How Were The Studies Designed?

The VITAL STUDY (JE Manson et al, New England Journal of Medicine, DOI: 10.1056/NEJMoa1811403 )in the United States. The study participants were 50% female, 50% male, and 20% African American. None of the participants had pre-existing heart disease. The characteristics of the study group were typical of the American population at that age, namely:

The average BMI was 28, which means that most of the participants were significantly overweight.
7% of them had diabetes.
38% were on cholesterol-lowering medications.
50% had high blood pressure treated by medication.

Study participants were given questionnaires on enrollment to assess clinical and lifestyle factors including dietary intake. Blood samples were taken from about 50% of the participants to determine omega-3 index at baseline and at the end of the first year. The participants were given a high purity omega-3 supplement (1 gram capsules containing 840 mg of total omega-3s, 460 mg of EPA, and 380 mg of DHA as the ethyl esters) or a placebo and followed for an average of 5.3 years.

There were two important characteristics of this study that distinguished it from the negative ASCEND study.

This study specifically excluded cardiovascular drugs other than statins and blood pressure medications because many of those drugs provide the same benefits as omega-3s. Patients in the ASCEND study were on 3-5 heart medications
The omega-3 status of participants at the beginning of this study was very low. The omega-3 status of participants in the ASCEND study was near optimal at the beginning of the study.

The REDUCE-IT study (DL Bhatt et al, New England Journal Of Medicine, DOI:10.1056/NEJMoa1812792 ): This study enrolled 8,179 participants (average age = 64) from several countries. The study participants were 70% male and 90% white. The average BMI was 31, which is considered obese. This study differed from the VITAL study in that all the patients were at high risk of heart disease.

70% of them had preexisting heart disease.
The remaining 30% had diabetes plus at least one additional risk factor for heart disease.
In addition, all of them had elevated triglycerides, which is an independent risk factor for heart disease.

The participants were given a high purity EPA supplement (4 grams of EPA as the ethyl ester) or a placebo and followed for an average of 4.9 years.

Do Omega-3s Reduce The Risk Of Heart Disease?

The VITAL Study: The primary end point for this study was something called “major cardiovascular events”, which was a composite every cardiovascular end point measured in the study. For this end point the results were negative. Omega-3 supplementation did not cause a significant decrease in major cardiovascular events compared to the placebo.

This was the result that was reported in the abstract and was what lazy journalists, who never read past the abstract, reported.

However, the rest of the study was very positive. For example, major cardiovascular events were reduced by:

26% in African-Americans.
26% in patients with diabetes.
17% in patients with a family history of heart disease.
19% in patients with two or more risk factors for heart disease.
19% in patients with low fish intake.

In other words, omega-3 supplementation caused a significant decrease in heart disease risk for high risk patients and for patients with a poor diet (low intake of omega-3s).

In addition, several individual cardiovascular events were significantly reduced by omega-3 supplementation. For example:

Heart attacks were reduced by 28% in the general population and by 70% for African-Americans.
Death from heart attacks was reduced by 50%.
Total coronary heart disease was reduced by 17%.
Death from coronary heart disease was reduced by 24%.

In short, headlines saying that omega-3 supplementation can decrease heart attack risk appear to be accurate. Saying that eating more fish can reduce heart attack risk is stretching it a bit. The study was not done with fish, and you would need to eat 2-4 servings of omega-3-rich fish a week to get an equivalent amount of omega-3s. That’s a lot of fish.

The authors attributed the positive results obtained in this study compared to the negative results obtained in several recent studies to four factors:

Many of the previous studies had fewer participants, used lower doses of omega-3s, and were shorter. There may not have been enough statistical power to demonstrate a benefit of omega-3s in those studies.
Participants in many of the previous studies were on multiple medications that mimicked the beneficial effects of omega-3s, making it more difficult to show a positive effect of omega-3 supplementation.
Most of the previous studies either did not measure the omega-3 status of participants or had a study population that started the study with near optimal omega-3 status. The VITAL study showed that omega-3s had a stronger beneficial effect for people who seldom ate fish.
African-Americans were underrepresented in most previous studies. The VITAL study showed that omega-3s were more beneficial for African-Americans than for other ethnic groups.

As for side effects, there was no increased risk of bleeding or any other serious side effect from omega-3 supplementation.

The REDUCE-IT Study: This study of high-risk patients was even more positive than the VITAL study.

The composite of all cardiovascular end points was reduced by 25%.
The risk reduction was greatest for men, non-whites, and people over 65.
The risk reduction was also greatest for people with pre-existing heart disease, very high triglyceride levels, and people who required high-dose statin therapy to keep their cholesterol under control.

In other words, everyone benefited from omega-3 supplementation in this study because they were all at high risk, but those at the highest risk benefitted the most.

When they looked at individual cardiovascular events:

Fatal and non-fatal heart attacks were reduced by 31%.
Cardiovascular death was reduced by 20% and death from any cause was reduced by 23%.
Fatal and non-fatal stroke was reduced by 28%.
Hospitalization for unstable angina was reduce by 32%.

However, this very high dose of EPA was not completely without risk:

1% of patients in the EPA group were hospitalized for atrial fibrillation versus 2.1% in the placebo group.
7% of patients in the EPA group experienced a serious bleeding event compared to 2.1% in the placebo group.

Do Omega-3s Reduce The Risk Of Cancer?

The VITAL Study: The VITAL study also looked at the effect of omega-3s on cancer risk. The results from this study were uniformly negative. There was no effect of omega-3 supplementation on invasive cancer of any type, breast cancer, prostate cancer, colon cancer, or death from cancer. Does that mean omega-3s have no role in reducing cancer risk? That’s not clear.

If we look at previous animal studies and human association studies, reduced cancer risk is seen when omega-3s replaced saturated fats, trans fats, and/or omega-6 fats in the diet. The subjects in the VITAL study ate a typical American diet, and the study made no effort to change what they were eating. It just added an omega-3 supplement. There is relatively little evidence that you can eat burgers and fries and expect omega-3s to reduce cancer risk.

The VITAL study merely confirms what previous studies have suggested. You can’t continue to eat a typical American diet and expect omega-3s to make cancer go away. Omega-3s should be thought of as part of a holistic approach to reducing cancer risk. If they have any role in reducing cancer risk, it is likely to be as part of a primarily plant-based diet that substitutes omega-3s for the bad fats in the American diet.

For example, the Mediterranean diet is primarily plant-based and is rich in healthy oils like olive oil and omega-3s. It is associated with reduced risk of several cancers, especially cancers of the breast and colon.

Are Omega-3 Supplements Good For You?

There is a lot of confusion around the question of whether omega-3s are good for the heart. Some studies say yes. Others say no. If you average all the studies together, as some recent meta-analyses have done, it is easy to throw up your hands and conclude there is no definitive evidence that omega-3s reduce heart disease risk. However, if you look at why the studies differ a clear pattern emerges.

If the study subjects are on multiple heart medications that duplicate the beneficial effects of omega-3s, the studies tend to be negative. If the subjects are only on one or two medications, the studies tend to be positive. Since most people I know would prefer to minimize the number of medications they are on, the negative studies with multiple medications are simply not relevant to them.
If the study subjects are at low risk of heart disease, the studies tend to be negative. If the subjects are at high risk, the studies tend to be positive. This does not mean that omega-3s are of no benefit if you are at low risk of heart disease. It simply reflects the fact it is easier to show a beneficial effect of any intervention when you have a pool of high-risk patients who are likely to experience some sort of cardiovascular event during the time-period of the study.

For example, as discussed in my recent book, “Slaying The Supplement Myths,” this the same pattern you see with statin clinical studies. If patients are at high risk, statin drugs clearly save lives. If they are at low risk, it is almost impossible to show any benefit of statin drugs. Cardiologists extrapolate from the high-risk studies and prescribe statins to low-risk patients. I think it is time to take a similar approach with omega-3s.

If the subjects have a good omega-3 status at the beginning of the study, additional omega-3 supplementation usually has no benefit. If their omega-3 status is poor at the beginning of the study, the results of omega-3 supplementation tend to be positive. This is just common sense. Supplementation is meant to fill gaps in the diet – not to provide a surplus of nutrients. Of course, the reality is many Americans do not get enough omega-3s in their diet.

What Do These Studies Mean For You?

Omega-3s Are Good For Your Heart: When you combine the latest studies with what we already know about omega-3s and heart disease, the results are clear-cut.

If you are at high risk of heart disease, don’t eat many omega-3-rich fish, and/or don’t want to be on a handful of heart medications, the evidence is strong that omega-3s reduce your risk of heart disease.
On the other hand, if you are at low risk of heart disease, eat 2-4 servings of omega-3-rich fish a week, and/or are happy taking multiple heart medications with all their side effects, it is difficult to prove that omega-3s have any benefits. That doesn’t mean that omega-3s don’t have benefits. It just means we can’t prove they do.

If you are still having trouble making up your mind whether omega-3 supplements are the right choice for you, I might remind you:

If you are like millions of Americans, the first sign you are at risk of heart disease might be sudden death.
If you are like most Americans, you are probably not getting enough omega-3s in your diet.
If you prefer taking drugs, you are probably not interested in supplements anyway.

Holistic Is Best: When you combine the VITAL study results with what we already know about omega-3s and cancer, it appears that adding omega-3s to a bad diet is unlikely to reduce your risk of cancer. However, a holistic approach that starts with a healthy, primarily plant-based diet and substitutes omega-3s for the bad fats in the American diet is likely to substantially reduce your cancer risk. The Mediterranean diet might be considered an example of that approach.

The same is likely true for heart health. While the latest two studies suggest that adding omega-3 supplements to your regular diet reduces your heart disease risk, those omega-3 supplements are likely to be even more effective if you also adopt a heart-healthy diet and lifestyle.

Omega-3 Supplements vs Omega-3 Drugs: The Omega-3 preparations used in this study are pharmaceutical-grade omega-3 preparations and are marketed as drugs. Thus, it is likely that many doctors will recommend them rather than less expensive omega-3 supplements. Which choice is best for you?

The preparation used in the VITAL study is similar in composition to many commercially available omega-3 supplements. The main difference is that it is high purity and is subject to the quality control standards required for pharmaceutical drugs. Many omega-3 supplements do not meet these standards, but some do. If you wish to use an omega-3 supplement, do your research. Inquire about their quality control standards and only buy high purity supplements.

The preparation used in the REDUCE-IT study used ultra-pure EPA only. That preparation did not contain any other omega-3s, so a commercially available omega-3 supplement would not be comparable. However, I do not recommend an EPA-only supplement for three reasons.

The results for high risk patients in the REDUCE-IT study were similar to those for high risk patients in the VITAL study. This suggests that removing DHA and other omega-3s may not provide additional protection against heart disease. A head to head comparison of the two supplements would be required to prove the superiority of an EPA-only supplement.
I have the same concern for this high-dose EPA supplement as I have for any high-dose single nutrient supplement. DHA and other omega-3s provide benefits such as cognitive health that EPA does not. Very high dose EPA is likely to interfere with the uptake and utilization of the other omega-3s.
The EPA only supplement used in the REDUCE-IT study had side effects that were not seen with the mixed omega-3 supplement used in the VITAL study. It is not clear whether those side effects were due to differences in dose or differences in formulation.

Omega-3 Ethyl Esters vs Omega-3 Triglycerides: There has been a lot of hype about the superiority of omega-3 triglyceride preparations recently. These studies were both done with omega-3 ethyl esters and proved to be very effective. Until someone shows that omega-3 triglyceride preparations provide better results at reducing heart disease risk than omega-3 ethyl esters, I would leave omega-3 triglyceride supplements on the shelf.

How Much Omega-3s Do You Need? We have too few dose-response studies to reliably predict how much omega-3s are optimal for reducing heart disease risk. The 1 gram/day dose used in the VITAL study gave good results, so that is an excellent starting point. The 4 gram/day dose used in the REDUCE-IT study seemed to provide little additional benefit.

Of course, the optimal dose is likely to be different for each of us. Once the omega-3 index blood test becomes more widely available I would recommend getting your omega-3 index determined on an annual basis and aiming for an omega-3 index of 8 or above, since that is the level associated with a low risk of heart disease.

The Bottom Line

However, two recent studies support the effectiveness of omega-3s for reducing heart disease risk. When you combine the latest studies with what we already know about omega-3s and heart disease, the results are clear-cut.

If you are at high risk of heart disease, don’t eat many omega-3-rich fish, and/or don’t want to be on a handful of heart medications, the evidence is strong that omega-3s reduce your risk of heart disease.
On the other hand, if you are at low risk of heart disease, eat 2-4 servings of omega-3-rich fish a week, and/or are happy taking multiple heart medications with all their side effects, it is difficult to prove that omega-3s have any benefits. That doesn’t mean that omega-3s don’t have benefits. It just means we can’t prove they do.

If you are still having trouble making up your mind whether omega-3 supplements are the right choice for you, I might remind you:

If you are like millions of Americans, the first sign you are at risk of heart disease might be sudden death.
If you are like most Americans, you are probably not getting enough omega-3s in your diet.
If you prefer taking drugs, you are probably not interested in supplements anyway.

In addition, one of the studies confirmed what we already know about omega-3s and cancer. Adding omega-3s to a bad diet is unlikely to reduce your risk of cancer. However, a holistic approach that starts with a healthy, primarily plant-based diet and substitutes omega-3s for the bad fats in the American diet is likely to substantially reduce your cancer risk. The Mediterranean diet might be considered an example of that approach.

For more details read the article above. In addition, the article covers topics like omega-3 supplements versus omega-3 drugs, omega-3 ethyl esters versus omega-3 triglycerides, and how much omega-3s we need. It also discusses why several recent studies have failed to find a benefit of omega-3s for reducing heart disease risk.

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.