August 29th, 2010
Alpha Omega Trial Tests Omega-3 Fatty Acids in CV Disease
Larry Husten, PHD
To test the effect of omega-3 fatty acids in cardiovascular disease, Kromhaut and colleagues with the Alpha Omega Trial Group randomized 4837 patients with a history of MI to treatment with one of four margarine preparations: one containing EPA and DHA; one with ALA; one with EPA, DHA, and ALA; or placebo. After 40 months, the rate of major cardiovascular events did not differ significantly across any of the groups. Among women, there was a trend toward a reduction in events in those who received ALA compared with those who received placebo or EPA/DHA. The results were presented at the ESC in Stockholm and published simultaneously in the New England Journal of Medicine.
“The patients in this trial were very well treated,” said Dr. Kromhout, in an ESC press release, “with 98% on antithrombotic agents, 90% on antihypertensive drugs, and 86% on lipid lowering drugs. We found that cardiovascular mortality rate in the study population was only half that expected, probably because of their excellent treatment. This may also be why the rate of major cardiovascular events during follow-up was no lower in the fatty acid groups than in the placebo group. “
3 Responses to “Alpha Omega Trial Tests Omega-3 Fatty Acids in CV Disease”
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I think a lot of people are disappointed with this one. At least the folks at my dinner table tonight. Makes us wonder if perhaps the ‘carrier’ wasn’t the right one (i.e. the margarine) or the dose was too low. Does this mean the end for these types of studies? I suspect probably not. At any rate, we’re still enjoying the Swedish gravlax and still hoping it’s really good for us…
When a government sponsors a study, do they ever consult experts in the field prior to setting up the parameters of the study? It is clear that the intent to treat with 400 mg EPA + DHA is a significantly inadequate dose. In addition, submerging the omega-3 in a margarine substrate that probably contains additional fatty acids which might undo some of the benefits of the omega-3 is a silly way to dose omega-3. Non-compliance with margarine consumption undoubtedly made the dose even more inadequate. This study provides the opposite of DATA (anti-DATA), which unfortunately might influence clinicians’ advice to patients regarding coronary prevention.
Another example of tax dollars at waste is the current NIH sponsored Vitamin D study which is being dosed at 1,000 IU. Anyone with any experience replacing vitamin D deficiency knows that 1,000 IU is an inadequate dose to raise the serum levels. Despite this obvious flaw, the study is under way and enrolling. The conclusions may be similar to this omega-3 study where the results will provide more anti-data.
Competing interests pertaining specifically to this post, comment, or both:
None
Agree with Susan and William on this omega-3 in CVD study. The cumulative evidence in favor of expanding omega-3 use in both prevention and treatment is not simply a preponderance–it is overwhelming. Of course not every study is supportive. However, most negative papers have serious methodological or other defects.
The reward to risk ratio associated with greater use of omega-3 is also egregiously high. There are multiple metabolic harms that result from the relative deficiency of omega-3 fatty acids in the American diet.
This is an example of how occasional, dismal lack of common sense may misdirect evidence-based medicine.
Richard Kones MD