Comment
Retraction and republication—Effect of a high-fat
See Articles Lancet Diabetes
Endocrinol 2016; 4: 666–76
See Comment Lancet Diabetes
Endocrinol 2016; 4: 633–35
For the Committee on
Publication Ethics’ guidelines
see http://publicationethics.org/
resources/guidelines
334
Mediterranean diet on bodyweight and waist
circumference: a prespecified secondary outcomes analysis
of the PREDIMED randomised controlled trial
On June 6, 2016, The Lancet Diabetes & Endocrinology
published online an analysis1 of secondary outcomes
from the PREDIMED trial, examining the effects of a
high-fat Mediterranean diet on bodyweight and waist
circumference, and the Article was published in print in
the August, 2016, issue of the journal.
In June, 2017, concerns were raised2 about the
implausibility of baseline data in the primary report
of the PREDIMED trial,3 and on June 14, 2018, the
primary report was retracted and republished with
updated analyses that accounted for protocol deviations
and departures from individual randomisation in
a subsample of participants.4 On June 14, 2018,
the Editors of The Lancet Diabetes & Endocrinology
contacted the authors to discuss whether and what
corrections were required to their report of analyses of
secondary outcomes,1 and published an Expression of
Concern5 to alert readers while these discussions were
ongoing. In view of the extent of changes necessary,
we determined that the previous version of the Article
should be retracted and a corrected version republished
after re-analysis and re-review, in accordance with the
Committee on Publication Ethics guidelines.
Today we retract the previous version and republish
the corrected version of the Article6 and appendix, in
which the findings have changed slightly—eg, 5 year
changes in bodyweight and waist circumference in the
Mediterranean diet with olive oil group were no longer
significant compared with the control group; 5 year
changes in waist circumference in the Mediterranean
diet with nuts group were still significant compared with
the control group. The overall messages of the paper are
similar. The updated version of the Article includes an
appendix file annotating all changes made to the paper.
We also publish a Correction to the linked Comment.7
The Editors of The Lancet Diabetes & Endocrinology
The Lancet Diabetes & Endocrinology, London EC2Y 5AS, UK
1 Estruch R, Martinez-Gonzalez MA, Corella D, et al. Effect of a high-fat
Mediterranean diet on bodyweight and waist circumference: a prespecified
secondary outcomes analysis of the PREDIMED randomised controlled trial.
Lancet Diabetes Endocrinol 2016; 4: 666–76.
2 Carlisle JD. Data fabrication and other reasons for non-random sampling in
5087 randomised, controlled trials in anaesthetic and general medical
journals. Anaesthesia 2017; 72: 944–52.
3 Estruch R, Ros E, Salas-Salvadó J, et al. Primary prevention of cardiovascular
disease with a Mediterranean diet. N Engl J Med 2013; 368: 1279–90.
4 Estruch R, Ros E, Salas-Salvadó J, et al. Primary prevention of cardiovascular
disease with a Mediterranean diet supplemented with extra-virgin olive oil
or nuts. N Engl J Med 2018; 378: e34.
5 The Editors of The Lancet Diabetes & Endocrinology. Expression of
concern—Effect of a high-fat Mediterranean diet on bodyweight and waist
circumference: a prespecified secondary outcomes analysis of the
PREDIMED randomised controlled trial. Lancet Diabetes Endocrinol 2018;
6: 763.
6 Estruch R, Martinez-Gonzalez MA, Corella D, et al. Effect of a high-fat
Mediterranean diet on bodyweight and waist circumference: a prespecified
secondary outcomes analysis of the PREDIMED randomised controlled trial.
Lancet Diabetes Endocrinol 2019; 7: e6–17.
7 Mozaffarian D. Food and weight gain: time to end our fear of fat.
Lancet Diabetes Endocrinol 2016; 5: 633–35.
www.thelancet.com/diabetes-endocrinology Vol 7 May 2019