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Cross-roads for meta-analysis and network meta-analysis of H. pylori therapy
  1. David Y Graham1,2,
  2. Ruben Hernaez1,2,3,
  3. Theodore Rokkas4
  1. 1Department of Medicine, Baylor College of Medicine, Houston, Texas, USA
  2. 2Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA
  3. 3Center for Innovations in Quality, Effectiveness, and Safety (IQuESt), Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA
  4. 4Department of Gastroenterology, Henry Dunant Hospital, Athens, Greece
  1. Correspondence to Dr David Y Graham, Department of Medicine, Baylor College of Medicine, Houston, TX 77030, USA; dgraham{at}bcm.edu

Abstract

Helicobacter pylori infections are responsible for tremendous morbidity and mortality worldwide, leading to efforts to eradicate the organism. However, the effectiveness of antimicrobial therapy has been undermined by the progressive development of antimicrobial resistance. Treatments and treatment guidelines have been based on traditional pairwise meta-analyses of randomised controlled trials. More recently, network meta-analyses have also been used in an attempt to provide useful information to the clinician regarding which therapies appear best and which to avoid as the least efficacious. However, both forms of meta-analysis have been undermined by the same problems including the poor quality of the clinical trials using unoptimised regimens and incomparable comparisons related to marked geographic and ethnic genotypic and phenotypic heterogeneity. In addition, the comparator regimens often consist of invalid strawman comparisons. New approaches concerning H. pylori treatment and analysis of therapies are needed. H. pylori therapies should be based on antimicrobial stewardship, as in other infectious diseases. This approach requires the use of only optimised therapies proven to be reliably highly effective in the local population (eg, a cure rate of >90%) for both the study and the comparator regimens. Meta-analyses should be restricted to regimens that meet these criteria and must take into account the presence of marked geographical and host genetic and phenotypic heterogeneity. In addition, to provide clinically relevant results, treatment outcomes should focus on, and present, actual cure rates in addition to odd ratios.

  • helicobacter pylori
  • meta-analysis
  • helicobacter pylori - treatment

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Footnotes

  • DYG and TR contributed equally.

  • Contributors All authors have read and approved the final manuscript and each meets the criteria for authorship established by the International Committee of Medical Journal Editors and verify the validity of the results reported. DYG and TR contributed equally and should share first authorship. DYG: study concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis, technical or material support; study supervision. RH: analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis, technical and material support. TR: study concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis, technical or material support; study supervision.

  • 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. RH is supported by the Center for Innovations in Quality, Effectiveness and Safety (CIN 13-413), Michael E. DeBakey VA Medical Center, Houston, Texas, USA.

  • Competing interests DYG is a consultant for RedHill Biopharma and Phathom Pharmaceuticals regarding novel Helicobacter pylori therapies and has received research support for culture of H. pylori. He is also a consultant for DiaSorin regarding H. pylori diagnostics and with Otsuka Japan regarding novel breath tests. He has ongoing collaborative research projects with American Molecular regarding molecular diagnostics for H. pylori. RH and TR have nothing to declare.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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