Fish Oil: It Conveys Much More Than Cardiovascular Health

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Numerous studies have evaluated the effects of the omega-3 fatty acids, DHA and EPA, on cardiovascular health. Overwhelmingly, scientists and clinicians involved in such research believe that omega-3 fatty acids play various beneficial roles in preserving optimal vascular and cardiac health: Anti-Inflammatory, Anti-Thrombotic, Anti-Arrhythmic, and TG-Lowering effects are considered to be the most relevant. Recently, Smith et al. published a fascinating and novel clinical trial looking at a non-cardiovascular yet widespread adverse aspect of aging: muscle mass decline. They published their findings in the American Journal of Clinical Nutrition: Fish oil–derived n–3 PUFA therapy increases muscle mass and function in healthy older adults. All parameters evaluated improved with the administration of 3,200 mg of daily DHA+EPA. Thigh muscle volume, handgrip strength, one-repetition maximum (1-RM) lower- and upper-body strength, and average power during isokinetic leg exercises all demonstrated statistically significant improvement. Improving muscle strength as we age can have far-reaching beneficial consequences that could reduce both morbidity and mortality. Thus, these findings need to be further studied in larger and even more consequential trials. But what additional meaning can we garner from their trial?

I believe that beyond their fascinating and clinically pertinent findings there actually lies a far more evocative message. It is simply that we should be extraordinarily cautious about abandoning the evaluation of therapies (even dietary) when they make biological and physiological sense. Fish oil consumption is woefully low in the US when compared to the far more healthy Japanese population. Our life expectancies are far shorter and various cancers occur more frequently in the US. It is scientifically quite plausible that our deficiency in omega-3 fatty acids plays a significant role in our relatively diminished health. But, after the publication of a few clinical trials failed to demonstrate the cardiovascular benefit of fish and fish oil in select patient populations, some physicians truly abandoned their prior admonitions for patients to augment fish consumption. They were derailed by the controversial results of just a few trials (that many exceptional researchers consider to be flawed in the first place). This type of knee jerk reaction has no place in medicine. It is dangerous and counterproductive. To protect our patients and maintain our scientific integrity, we must always practice with open and attentive minds. Once again I implore my scientific colleagues as well as the oftentimes superficially inquisitive media to follow the science, not the hype.

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An Update From the 2014 American Society for Preventive Cardiology (ASPC) Annual Meetings

Two weeks ago was the ASPC’s Annual meeting in Boca Raton, FL. The event was superb. Internationally recognized experts in a variety of disciplines convened in Boca Raton for the three–day-event. Nearly 200 healthcare practitioners from around the country came to listen to Professors from Northwestern, Harvard, NYU, The Mayo, Columbia University, The Miami Miller School of Medicine, Emory, Ohio State, UCLA…  Topics such as the somewhat controversial 2013 ACC/AHA Cholesterol and Obesity Guidelines, the enormously under-recognized disorder Familial Hypercholesterolemia, and the vast sex differences in CVD presentation and treatment were discussed.

My lecture was entitled, “The Omega-3 Fatty Acids DHA and EPA: Caution when interpreting the Trials. It’s time to get back to the basics.”  The talk highlighted enormous limitations inherent in recent omega-3 studies. It is not only clinicians and laypeople who must understand such issues, but the press as well. Too many reporters – and even physicians in the news – misinterpret clinical studies, oftentimes sending not just misleading messages to the pubic, but potentially damaging ones as well.

DHA and EPA are the essential fatty acids found in fish, NOT flax, Chia, or olive/canola oil. These fatty acids have been studied in a variety of disorders ranging from heart attacks to dementias, ADHD, eye disease, inflammatory bowel disorders, and Rheumatologic ailments. The list is actually even more extensive than this. Their benefits are legion – anti-inflammatory, anti-oxidant, anti-arrhythmic, and anti-thrombotic to name a few. Scientists across the globe are spending their entire careers evaluating the myriad biological effects of these fatty acids. Although we still do not know precisely how DHA and EPA will fit into our medicinal armamentarium, we do know that they have an important role to play. More studies and clinical trials are needed. One thing is clear however. DHA and EPA are here to stay. They represent a component in our diets that should be emphasized, not neglected. Nearly daily fatty fish or fish oils should be a part of most people’s dietary habits.

Beyond the value of DHA and EPA is an even more important message though. The media, in their unbridled attempt to produce quick and enticing stories, often critically misses the mark. Consequently we all must be very careful about how we interpret what we read or hear. We must always be vigilant when drawing conclusions about our health as well as other consequential matters.

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ConsumerLab Approval: A Brief Boast about VitalOils1000

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I make it my practice not to blog about VitalRemedyMD or any of its products, but this week demands a self-promoting shout-out. VitalRemedyMD is a company I started over ten years ago. It is now owned and operated by my wife (Laura Baum – also an MD). VitalOils1000 was created about six years back as the first and only enteric-coated fish oil pill to contain a full 1,000 mg of combined DHA and EPA. Thus, VitalOils1000 was the first omega-3 fish oil to meet the American Heart Association recommendation for individuals with cardiovascular disease in just one pill. This fact holds true even when considering prescription fish oil.

Yesterday we made the grade again. On April 6th, the preeminent watchdog of the nutritional supplement world, released their every-other-year study of omega-3 fish oil products. Once again VitalOils1000 was “approved.” This year, in addition to “proving” our purification, concentration, and quality of enteric coating, we were also tested for PCBs and Dioxins. We were one of only two products tested in this comprehensive fashion, and we “passed” this important criterion as well. Our purification process of supercritical fluid technology enables us to achieve these exceptionally high standards for safety and purity.  There is so much confusion about omega-3 products that I felt compelled to write about our continued success with VitalOils1000. Needless to say, I am very proud. Thank you for permitting me a moment to boast.

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Beware the Pervasive Reach of Bias – Fish Oil Study Questioned

“Striking a Nerve: Bad Odor to This Fish Oil Study” was the catchy and misleading title for a MedPage headline last week. The “fishy study” to which the cynic refers was published in The American Academy of Neurology. Not exactly a shabby journal. The authors – William Harris, PhD and James Pottala, PhD – erudite and prolific contributors to omega-3 fatty acid research examined the brains of aging women from the Women’s Health Initiative Memory Study and noted a statistically significant association between hippocampal size and omega-3 RBC (Red Blood Cell) levels. In other words, women with low levels of the omega-3s DHA and EPA had more hippocampal atrophy than those with high levels. The importance here is that dementia is frighteningly prevalent (affecting 20% of women) and the hippocampus is likely playing a causal role in its development. Therefore, if we can identify factors – whatever they may be – that prevent hippocampal atrophy, we must pay close attention and examine them further. This is precisely what the authors stated; their findings were encouraging and hypothesis generating. In fact, their final statement, “This study thus adds to the growing literature suggesting that higher omega-3 FA tissue levels, which can be achieved by dietary changes, may hold promise for delaying cognitive aging and/or dementia” does not declare certainty, simply solid hope.

Why then would this study be unfairly condemned? This is a somewhat rhetorical question as I don’t have a clear answer. What I can say with certainty though is that no one should read or listen to an opinion and accept it as fact without first going to the primary source. Everyone would agree this to be true in politics. We must now sadly acknowledge its validity in the world of science as well.

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Age-Related Eye Disease Study 2 (AREDS2) – an Analysis

What follows is an analysis of the results of the AREDS2 randomized clinical trial “Lutein Zeaxanthin and Omega-3 Fatty Acids for Age-Related Macular Degeneration” (AREDS2) recently published on the JAMA website.

AREDS 2 has been long-awaited. AREDS1 demonstrated decreased progression of AMD with the administration of high dose antioxidants and minerals. There were problems with AREDS1 though; beta-carotene was used whereas lutein and zeaxanthin were not. High dose zinc appeared to increase hospitalizations for GI and GU disorders. The omega-3s DHA and EPA were omitted. In response to these shortcomings, AREDS 2 was established. Now the results are in. Unfortunately the trial raises more questions than it answers.

Here are the issues.

  • Although it is called a “placebo controlled” trial, there is no placebo arm. Everyone in the placebo group was offered the AREDS1 formula as a base. Nearly everyone took it. This confounds results.
  • The use of prior supplementation with omega-3s and carotenoids was not controlled for. As baseline blood levels for lutein, zeaxanthin, DHA, and EPA were higher than normal, the participants likely had a high use of prior supplementation. This confounds results.
  • The omega-3s chosen were 350 mg DHA and 650 mg EPA, yet DHA is known to be a necessary structural element in the macula whereas EPA is thought to be the precursor for signaling molecules that might be important for the eye. DHA is a known quantity; EPA has hypothetical value.
  • The study was enormously complex: Two tiers of randomization occurred in this 2×2 factorial trial. Patient groups included:  (1). Placebo – actually on AREDS1 formula. (2). AREDS1 + EPA/DHA. (3). AREDS1 + lutein/zeaxanthin. (4). AREDS1 + EPA/DHA/lutein/zeaxanthin. (5). AREDS1 + 25 mg Zn (not 80 mg). (6). AREDS1 – beta carotene. (7). AREDS1 with 25 mg Zn and no beta-carotene. Such a complex study design created a great deal of difficulty in understanding the findings. In the authors’ own words, “complicated design involving a secondary randomization which may have affected our ability to evaluate the role of adding lutein+zeaxanthin and DHA+EPA to the AREDS formula”. This unfortunately is the crux of the trial. Introducing doubt in the primary objective of the study is “study suicide” in my view.
  • 30% of participants opted not to undergo the secondary randomization and among those who did decide to move forward, women and highly educated participants did so at a significantly higher rate. This confounds the results.
  • 13% of participants stopped their supplements during the trial. As this was an Intention to Treat study, they remained in the trial even though they were “off drug”.
  • 14% of participants admitted to taking lutein/zeaxanthin/DHA/EPA during the trial even though they were not supposed to do so. This confounded the results.
  • Only 84% of participants took > 75% of their pills.
  • A small portion of patients had blood tests of studied supplements. There was a 200% increase in lutein/zeaxanthin and a 105% increase in EPA, but because of the low dose of DHA there was only a 35% increase in its level.
  • Beta-carotene lowered the effect of lutein, proving the negative interaction between these two carotenoids. This was unexpected by the authors. They stated, “In this analysis we assumed there would be little interaction between the various nutrients used”. To me, this statement is disturbing; this is a nutrient trial. Interactions between nutrients are inevitable and must be considered in such a trial design. This is one of the fatal flaws of the trial.
  • Beta-carotene increased lung cancer. This was previously understood but reconfirmed. In fact, 91% of lung cancer cases occurred in patients taking the standard AREDS formula. Though the patients were former smokers, they were not current smokers. In my view this negates the use of the standard AREDS formula in anyone with a history of smoking.
  • Low dose zinc and the absence of beta-carotene did not diminish efficacy of the formula. This demonstrates that low dose Zn and no beta carotene are preferred.
  • Lutein/Zeaxanthin did demonstrate less AMD progression compared to the AREDS1 formula.

In sum, AREDS2 was a wonderful concept that was poorly implemented. The take-home message from the trial: Do not use beta-carotene; use lutein and zeaxanthin; low dose zinc is optimal; efficacy of omega-s remains unanswered. Interestingly, the May, 2013 issue of JAMA Ophthalmology included the LUTEGA trial in which DHA and lutein/zeaxanthin were found to be beneficial in AMD. LUTEGA used DHA in a dose 3x that of EPA, the relationship that probably should have been used in AREDS2. One final note, meso-zeaxanthin was not studied in either trial. Based upon our current understanding of pathophysiology and biology meso-zeaxanthin should be included in an AMD formulation.

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