In 2013, the results of a randomized trial of the Mediterranean diet were published in the New England Journal of Medicine and generated a great deal of interest among nutrition researchers and the public at large. This study—now known by the acronym PREDIMED (Prevenciόn con Dieta Mediterránea)—had examined the association between adherence to a Mediterranean diet supplemented with extra-virgin olive oil or nuts and cardiovascular risk. The conclusions of this study, which had enrolled 7447 individuals between the ages of 55 and 80, were that this dietary approach reduced the incidence of cardiovascular disease.

Dr. John Carlisle is a British anaesthesiologist who has developed a new method of analyzing data sampling in clinical trials. For several years Dr. Carlisle has been evaluating many published studies using his statistical methodology. He has reported irregularities in randomization in a wide range of trials connected to numerous fields of medicine, and his findings have cast double on the validity of the data in many important studies, the 2013 PREDIMED trial among them.

As a result of Dr. Carlisle’s reports, the new England Journal of Medicine identified 11 published studies in which baseline variables were determined to be questionable. The 2013 PREDIMED article was retracted, but—in what may be the first situation of this kind—the original study authors reexamined all of their data to check their findings against the new statistical analysis methods. They rewrote the findings and resubmitted the work for publication, which the New England Journal of Medicine published in the June 21, 2018 issue.

Dr. Jeff Bland has many insights to share about this series of developments and he offers his takeaways in this new video blog.

References
Tracy SW. Something new under the sun? The Mediterranean diet and cardiovascular health. N Engl J Med. 2013 Apr 4;368(14):1274-6.

Estruch R, Ros E, Salas-Salvado J, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90.

Estruch R, Ros, Salas-Salvado J, et al. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. N Engl J Med. 2018 Jun 21;378(25):e24.

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