Citing “irregularities” in their “randomization procedures,” the authors of a 2013 study published in the New England Journal of Medicine that hailed the Mediterranean diet as a preventer of heart disease retracted the paper and replaced it with a new one.
The authors’ conclusion is the same: the popular diet consisting of fruits, vegetables, nuts and olive oil can prevent heart disease, but the language is softened and more modest. That is, the authors reversed their original conclusion that the diet was the actual driver of those health benefits, NPR and The Washington Post reported.
It was a rare move that signaled the results of the study can’t be trusted and are beyond correction, NPR reports.
However, one of the study’s authors seemed to stand by the original study, saying that the changes “affected only a small part of the trial.”
“We are now more convinced than ever of the robustness of the trial and of the conclusions,” lead author Miguel Martínez-González of the University of Navarra told the Post. “No previous trial has undergone such intense scrutiny.”
Regardless, the retraction and new report raised eyebrows of industry experts.
“I don’t know anybody who would turn around from this and say, ‘Now that this has been revealed, we should all eat cotton candy and turn away from the Mediterranean diet,'” David Allison, dean of the School of Public Health at Indiana University, told NPR.
However, “the legs have been kicked out from under it, in some sense,” Allison told NPR.
The retraction started with the work of a British anesthesiologist named John Carlisle, who set out to prove – and did – the flaws of randomization in clinical trials. Carlisle taught himself how to discover patterns and anomalies of randomization, the outlets reported.
Carlisle’s sleuthing led to a perfected method that he then applied to thousands of clinical trials published in eight journals, including the Mediterranean diet and five others in the NEJM that are being corrected.
“I think that the NEJM editorial team responded very maturely to my paper,” Carlisle told NPR. “They took the possibility of a problem seriously and acted quickly and thoroughly.”
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