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An Analysis of 5 Years of Randomized Trials in Gastroenterology and Hepatology Reveals 52 Medical Reversals

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An Editorial to this article was published on 31 August 2021

Abstract

Background and Aims

One manifestation of low-value medical practice is the medical reversal, a practice in widespread use that, once subjected to a randomized controlled trial (RCT), is found to be no better—or worse—than a prior established standard of care. We aimed to determine the prevalence of medical reversals in gastroenterology (GI) journals and characterize these reversals.

Methods

We searched the American Journal of Gastroenterology, Clinical Gastroenterology and Hepatology, Gastroenterology, Gut, Hepatology, and the Journal of Hepatology, reviewing studies published in 2015–2019. We identified RCTs that tested an established clinical practice and produced negative results, considered tentative reversals. Any systematic review or meta-analysis that included the article was categorized as confirming the reversal, refuting the reversal, or providing insufficient data.

Results

During the 5-year period, we identified 5,898 original articles, of which 212 tested an established practice and 52 were categorized as unrefuted medical reversals (25% of articles testing standard of care). Of the reversals, 21 (40%) tested procedures and devices, 15 (29%) tested medications, and 8 (15%) tested vitamins/supplements/diet. Twenty-three (44%) considered the alimentary tract, 12 (23%) considered the liver, pancreas, or biliary tract, and 17 (33%) considered endoscopy. Thirty-eight (73%) were funded exclusively by non-industry sources.

Conclusion

This review reveals a total of 52 reversals across all subfields of GI and medical, procedural, screening, and diagnostic interventions, occurring in 25% of randomized trials testing an established practice. More research is needed to determine the optimal way to engage stakeholders and remove reversed practices from medical care.

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Funding

The authors received no specific funding for this work. MCY, AMM, and SL have no financial, professional, or personal potential competing interests to disclose. AH: (Research funding) Arnold Ventures. VP: (Research funding) Arnold Ventures; (Royalties) Johns Hopkins Press, Medscape, MedPage; (Consulting) UnitedHealthcare; (Speaking fees) Evicore; New Century Health; (Other) Plenary Session podcast has Patreon backers. BL: (Research funding) The Louis and Gloria Flanzer Philanthropic Trust; (Consulting) Takeda, Anokion.

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Authors and Affiliations

  1. Department of Internal Medicine, Columbia University Irving Medical Center, 622 W 168th Street, New York, USA

    Margot C. Yopes & Alexander M. Mozeika

  2. Columbia University Vagelos College of Physicians and Surgeons, 630 W 168th Street, New York, USA

    Simon Liebling

  3. Department of Epidemiology and Biostatistics, University of California San Francisco, 550 16th Street, 2nd Floor, San Francisco, USA

    Alyson Haslam & Vinay Prasad

  4. Division of Gastroenterology, Department of Internal Medicine, Columbia University Irving Medical Center, 180 Fort Washington Avenue, Suite 936, New York, USA

    Benjamin Lebwohl

  5. Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, 722 W 168th Street, New York, USA

    Benjamin Lebwohl

Authors
  1. Margot C. Yopes
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  2. Alexander M. Mozeika
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  3. Simon Liebling
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  4. Alyson Haslam
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  5. Vinay Prasad
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  6. Benjamin Lebwohl
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Contributions

MCY contributed to the conception and methodology of the study, data acquisition and analysis, and original draft preparation. AMM and SL contributed to data acquisition and analysis and original draft preparation. AH and VP contributed to the conception and methodology of the study and draft review and editing. BL contributed to the conception and methodology of the study, data analysis, and draft review and editing.

Corresponding author

Correspondence to Benjamin Lebwohl.

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Ethical approval

This was a retrospective study of publicly available, previously published literature. As no patient data was included, no ethical approval was required.

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An editorial commenting on this article is available at https://doi.org/10.1007/s10620-021-07240-7.

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Yopes, M.C., Mozeika, A.M., Liebling, S. et al. An Analysis of 5 Years of Randomized Trials in Gastroenterology and Hepatology Reveals 52 Medical Reversals. Dig Dis Sci 67, 2011–2018 (2022). https://doi.org/10.1007/s10620-021-07199-5

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  • DOI: https://doi.org/10.1007/s10620-021-07199-5

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