Heartfelt with Dr Melissa Walton-ShirleyView all posts »
The Alpha Omega fish-oil trial: Sabotaged by "greatness"?Aug 29, 2010 10:40 EDT
Fish-oil and plant-based (ALA) supplements didn't lower MACE in patients age 60 to 80 who had suffered a prior MI, and it didn't reduce the number of procedures either. Like everyone else, I was disappointed in this study outcome. As a matter of fact, I almost didn't comment on it because it was quite frankly, "lackluster." However, a closer look at what exactly we can take away from this presentation garners a bit of interest.
Every single participant was required to ingest four slices of bread per day slathered with an omega-3– and/or ALA-containing margarine. My first thought was that perhaps the carbohydrate intake offset the benefits of this regimen. Since we are instructed to limit carbs to a healthy 70 g per day to lose weight and a total of 150 carbs per day to avoid weight gain, for some of us that is a significant increase in our daily carb intake. Four slices of bread, depending upon the type and the thickness of the slice, can amount to anywhere from 48 to 60 extra carbs/day. Although there was no recorded weight gain in this trial, the impact of a carb load on glucose metabolism can be very significant. For those who don't believe it, ingest 75 g of glucola, and stick your finger in an hour, and see just how high the glucose of the average human being (well, at least, the average moderately obese American) can soar. To say we are "too sweet" is an understatement. Many of my patients hit a total blood sugar of over 200 mg/dL in the first hour. Since we glycosolate our hemoglobin every single time we go over 180 mg/dL, that's an awful lot of sugar carried to places within our body that it was never meant to be—hence, blindness, kidney failure, coronary artery disease, stroke, and heart attacks abound in the "sweet" population. The study design could have called for a moderately better vehicle for delivery of "healthy" fat to have avoided this question all together.
More important was the point that these patients were exceptionally well treated: 98% were on antithrombotic agents, 90% on antihypertensive therapy, and 86% were taking lipid-lowering medications. In the real world, patients comply with medication regimens less than 50% of the time. It makes one wonder just how well the fish-oil and ALA patients would have done if they had been pitted against patients who weren't under the microscope of study design and follow-up. An "enroll-and-go-your-own-way" arm of this trial might have been an interesting comparator. Perhaps an even better study would have been to pit statin and antiplatelet drugs against fish oil NOT slathered atop a slice of bread, four times daily. As this study suggests, you get much better than "great," and future study designs need to consider this point prior to taking a theory to prime time: remember not to sabotage the study from the outset.
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Aug 29, 2010 16:25 EDT Next post »
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