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Letter
Vonoprazan Helicobacter pylori eradication therapy: ethical and interpretation issues
  1. David Y Graham
  1. Correspondence to Dr David Y Graham, Department of Medicine, Baylor College of Medicine and Michael E DeBakey Veterans Affairs Medical Center, RM 3A-318B (111D), 2002 Holcombe Boulevard, Houston, TX 77030, USA; dgraham{at}bcm.edu

https://doi.org/10.1136/gutjnl-2016-311796

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    We read with interest the important study on vonoprazan in Helicobacter pylori eradication therapy.1 Vonoprazan likely represents a significant advance in antisecretory and H. pylori eradication therapy. Despite being technically well done, several issues related to study conduct and interpretation remain. Their sample size was based on 90% success with lansoprazole, which has not been achieved in Japan for several decades. When the cure rates proved to be lower, the sample size was increased to ‘maintain the statistical power of the study’. We question whether this was ethical. It is generally considered unethical to randomise against a regimen that provides unacceptably low cure rates; many journals reject papers that do this.2 , …

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    Footnotes

    • Funding DYG is supported in part by the Office of Research and Development Medical Research Service Department of Veterans Affairs, Public Health Service grant DK56338 which funds the Texas Medical Center Digestive Diseases Center.

    • Competing interests DYG is a paid consultant for RedHill Biopharma regarding novel H. pylori therapies and for BioGaia regarding use of probiotics for H. pylori infections.

    • Provenance and peer review Not commissioned; internally peer reviewed.

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