Omega XL Supports Science Community’s Criticism of Flawed JAMA Article Negating Cardiac Support of Omega-3s

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Analysis of selected studies, published recently in JAMA, suffers from flaws that render its conclusions against omega-3s, as found in Omega XL, misleadingly negative.

The newswires have erupted recently with a flood of reports covering a recent analysis that appeared in the Sept. 12 issue of the Journal of the American Medical Association (JAMA). A Greek team, based at the University Hospital of Ioannina, initiated the analysis. Their contention was, while virtually everything known about the effects of omega-3s - such as found in Omega XL- in humans suggests that they benefit cardiovascular and overall health, others have refuted those claims.

Despite a body of scientific evidence that encompasses literally thousands of publications demonstrating the benefit of omega-3s for cardiac health, the Greek authors insisted, “The controversy stemming from the varying labeling indications causes confusion in everyday clinical practice about whether to use these omega-3s for cardiovascular protection.”

This prompted the researchers to perform a large-scale systematic review and analysis of the available “randomized” evidence to determine the association between omega-3 polyunsaturated fatty acids (PUFAs) and major cardiovascular events.

Of the 3,635 citations retrieved, the JAMA article encompassed just 20 published studies – less than 1% - that included 68,680 randomized patients, reporting 7,044 deaths: 3,993 cardiac deaths, 1,150 sudden (cardiac) deaths, 1,837 Myocardia Infarctions (heart attack) and 1,490 strokes. The authors concluded, while randomized evidence will continue to accumulate in the field, “omega-3 PUFAs are not statistically significantly associated with major cardiovascular outcomes across patient populations. Our findings do not justify the use of omega-3 as a structured intervention in everyday clinical practice or guidelines supporting dietary omega-3 PUFA administration.”

Do we now cast aside the positive results of tens of thousands of peer reviewed and published research articles, spanning decades, in favor of a single analysis of just 20 randomized trials? A recent article published in the journal Heart Views (2012 Apr-Jun; 13(2): 66–68.) offers some constructive analysis. In the article, Dr. MostafaYakoot Consultant Physician at the Green Clinic and Research Centre at Alexandria, Egypt, suggests that in this era of overwhelming dataflow, it should be emphasized that it is important to consider not only the level of evidence “as dictated by the study design and sample size” but also the relevance of evidence. “Studies tell us about populations while we treat individuals.”

The type of patient, the enrollment criteria, the methodology, the dose of the studied drug, and all the combined medications being taken by the participants in the study should be clearly considered whenever the reported results are to be generalized beyond the specific situation studied. Comparing the effect of an active drug with multiple mechanisms of action against a placebo by giving either one of them to a group already treated with other multiple drugs could be a misleading indicator for the effectiveness of the active drug.

Many confusing variables such as known or unknown drug interactions or unexpected adverse drug reactions can afflict only the group randomized to take the drug being researched. These variables will not affect the control group simply because they are adding an inert placebo to all the drugs they are already taking to manage their condition. By using common sense, we can argue that comparing the effect of an active drug with multiple mechanisms of action (such as Omega-3 fatty acids) against a placebo by giving either one of them to a group already treated with other multiple drugs could be a misleading indicator for the efficacy of the substance being studied.

The bottom line is that omega-3s are among the top selling supplements in the world for a reason. Omega-3s have been the subject of perhaps the most exhaustive clinical research of any other nutraceutical in existence, demonstrating substantial support for not only heart, but also lung, eye and brain health as well as potent mediators of both chronic and acute inflammation. Just in consideration of the omega imbalance imposed on the population by the substantial influx of pro-inflammatory omega-6 fats in the typical Western diet, daily supplementation of quality omega-3s can’t be ignored.

Omega XL is one of only two Omega-3 supplements sold in the world that contains the patented stabilized marine lipid extract PCSO-524™ derived only from the New Zealand green-lipped mussel, with 30 healthy fatty acids including DHA and EPA. Sold in other parts of the world under its sister brand name Lyprinol, Omega XL is manufactured exclusively by Great HealthWorks Inc., and is the most widely available omega-3 fish oil supplement containing the potent PCSO-524™ marine lipid extract. To find more information about Omega XL and PCSO-524™ visit

About Great HealthWorks, Inc.
Great HealthWorks, founded in 2003, is a global manufacturer and distributor of one-of-a-kind, natural products. Great HealthWorks, the makers of Omega XL®, an all-natural, highly purified marine lipid extract from the green-lipped mussel (Perna Canaliculus) known as PCSO-524™. This patented marine lipid complex comes exclusively from the pristine waters of the Marlborough Sounds in New Zealand, and contains 30 healthy fatty acids. Great HealthWorks corporate headquarters and distribution center are in Hollywood, Florida. To find out more about Great HealthWorks, visit And for more information about the benefits of Omega XL, visit Join the conversation:

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Miles Dupree
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