This article was first published on March 25, 2023. It was last reviewed/ updated on March 25, 2023.
In February, Medscape, a leading medical education website, published an article titled “Psychiatrist Effort Prompts Retraction of Antidepressant Paper“.
This article made me sit up because I have been aware for many years that papers of questionable reliability are being published and have been very careful in selecting which articles to use while writing articles for this website. I had discussed this issue with the Editorial Board of Simple and Practical Medical Education but avoided saying anything publicly.
Here’s a brief summary of what I understand of the Medscape article.
Eric Ross, MD, heard on a popular psychiatry podcast that a team of researchers in Egypt had reported that adding metformin to antidepressant medications increased their efficacy to an amazing extent.
To Dr. Ross’s credit, he looked up the actual study (Abdallah et al., 2020) instead of starting to prescribe adjunctive metformin to his patients. And, apparently, he reads papers thoughtfully and with a critical eye because he noticed several things in the paper that seemed odd:
– For 17 out of 18 adverse events, the number of patients who experienced that adverse event on metformin or placebo differed by exactly one. That seemed improbable.
– All of the many statistical tests reported in the paper showed statistically significant results. In real life, that rarely happens.
– Many of the numbers in the paper were very similar to numbers reported in another augmentation clinical trial that the authors had published, which also had very impressive results (Abdallah et al., 2021).
– The corresponding author had also published many other papers with improbable elements.
Medscape noted that Dr. Ross had “no doubt the data was fake” and quoted him as saying: “I was really mad because this is the kind of thing that can immediately affect patient care.”
He wrote to the journals that had published the two papers. The journal that had published the metformin paper retracted the paper, noting that (emphasis added by us):
“Concerns have been raised about the data presented. The response from the authors to these concerns has shown that there are serious issues with the ethical oversight, the reporting and the availability of audited data for this clinical trial. The Editor-in-Chief therefore no longer has confidence in the results and conclusions presented“.
But, unfortunately, it had already been cited by 27 other papers.
The cilostazol augmentation of antidepressants paper (Abdallah et al., 2021) has still not been retracted!
Abdallah MS, Mosalam EM, Zidan AA, Elattar KS, Zaki SA, Ramadan AN, Ebeid AM. The Antidiabetic Metformin as an Adjunct to Antidepressants in Patients with Major Depressive Disorder: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial. Neurotherapeutics. 2020 Oct;17(4):1897-1906. doi: 10.1007/s13311-020-00878-7. Retraction in: Neurotherapeutics. 2022 Sep;19(5):1687. PMID: 32500486; PMCID: PMC7851215.
Retraction note: Abdallah MS, Mosalam EM, Zidan AA, Elattar KS, Zaki SA, Ramadan AN, Ebeid AM. Retraction Note: The Antidiabetic Metformin as an Adjunct to Antidepressants in Patients with Major Depressive Disorder: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial. Neurotherapeutics. 2022 Sep;19(5):1687. doi: 10.1007/s13311-022-01291-y. PMID: 36071262; PMCID: PMC9606185.
Abdallah MS, Ramadan AN, Omara-Reda H, Mansour NO, Elsokary MA, Elsawah HK, Zaki SA, Abo Mansour HE, Mosalam EM. Double-blind, randomized, placebo-controlled pilot study of the phosphodiesterase-3 inhibitor cilostazol as an adjunctive to antidepressants in patients with major depressive disorder. CNS Neurosci Ther. 2021 Dec;27(12):1540-1548. doi: 10.1111/cns.13731. Epub 2021 Sep 21. PMID: 34545997; PMCID: PMC8611782.
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