Nearly 20 years after the publication of a paper on phytoestrogens in postmenopausal women, one of the authors said the study had never been performed, according to a recently published retraction notice.
The retraction is the second for two of the authors. It comes after sleuth Ben Mol and his colleagues initially discovered data similarities between the recently-retracted study and another by the same group, as we reported last year.
The two papers that seem to share data appeared in Fertility and Sterility, an Elsevier publication, in 2004 and 2006.
Table 1 of the 2006 paper “Psychological assessment of the effects of treatment with phytoestrogens on postmenopausal women: a randomized, double-blind, crossover, placebo-controlled study” was identical to Table 1 of the 2004 article “Endometrial effects of long-term treatment with phytoestrogens: a randomized, double-blind, placebo-controlled study.”
Despite a threefold difference in participant number between the two studies, both groups of women represented in the tables had a 165.5 centimeter mean height and the same standard deviation.
Only the 2006 article was retracted:
The corresponding author did not reply to inquiries; however, one of the coauthors did respond and admitted that the study published above was not actually performed. Inquiries were made to the coauthors and their institutions, who did not provide any information to alter or contradict this admission. Therefore, the [Publications] Committee has determined to retract the article.
The paper has been cited 104 times, according to Clarivate’s Web of Science.
Meredith Sauls, managing editor of Fertility and Sterility, said in an email to Retraction Watch the journal has “nothing to add to the published retraction.” She did not respond to our questions regarding a potential investigation of the 2004 paper.
The two papers shared two co-authors, Vittorio Unfer, a professor at the International Medical University in Rome, and Maria Luisa Casini, currently a pharmacologist at Italian Medicines Agency in Rome. At the time of the publications, both were researchers at Sapienza University in Rome. Neither responded to our request for comment.
Enrico Papaleo, a co-author of the 2006 study and a gynecologist in Milan, left a comment on PubPeer about a paper by the same group retracted in 2023:
In consideration of concerns raised about this article above, I would like to point out that my participation in this study did not include clinical management of patients or database management. In view of the concerns raised, I no longer take responsibility for these papers. Apart from this public statement, I have informed the journal about my position.
Papaleo did not respond to our request for comment.
Last year, a 2001 paper by Unfer, Papaleo, and Guido Marelli, a co-author of the retracted 2006 article, received an expression of concern. Gian Carlo Di Renzo, a co-author of the 2004 study and a researcher at the University of Perugia, was also an author of the paper, which was published in Gynecologic and Obstetric Investigation. The notice cites concerns about “similarities between the results presented in Figure 1 and Figure 2,” and states the corresponding author stood by the data, blaming “local data storage regulations” for why the original data were lost.
Grainne McNamara, a publication ethics manager at Karger Publishers, said Gynecologic and Obstetric Investigation is “aware” of the 2006 article. “We immediately contacted the research integrity team at the publisher of Fertility and Sterility in December 2024 to request more information and the investigation remains ongoing.”
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