Helicobacter pylori eradication therapy research: Ethical issues and description of results

Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association
David Y Graham

Abstract

As an infectious disease, the approach to anti-Helicobacter pylori therapy differs from other common gastrointestinal conditions because treatment success of more than 90% to 95% should be expected and the reasons for treatment failure can always be understood. Neither comparisons with another regimen nor randomization are required to identify a highly successful therapy. Treatment success should be judged first in relation to outcome (ie, ≥95% or grade A). Inclusion of a known inferior regimen in a clinical trial is generally unethical. If the use of a known inferior drug is required by a regulatory agency, subjects must be given full and accurate information regarding expectations with each regimen; there can be no deceptions. Comparative trials should be restricted to highly successful treatments (ie, comparisons of different doses, durations, compliance, cost, and so forth). Success should be judged as ordered categories such as <85%, 85%-89%, 90%-94%, or ≥95% and statistically equivalent regimens with the same grade success (ie, 90%-94% [Grade B]) are inferior to those higher category (ie, ≥95% [Grade A]) regimens. Only grade A or B regimens should be prescribed. Here we discuss anti-H pylori eradication studies from the p...Continue Reading

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Citations

Mar 11, 2011·Journal of Clinical Gastroenterology·David Y Graham, Emiko Rimbara
Sep 1, 2010·Indian Journal of Medical Sciences·Selvi Thirumurthi, David Y Graham
Mar 13, 2012·World Journal of Gastrointestinal Pharmacology and Therapeutics·Ayako YanaiShin Maeda
Feb 3, 2016·The American Journal of Gastroenterology·Jyh-Ming LiouUNKNOWN Taiwan Gastrointestinal Disease and Helicobacter Consortium
Jun 12, 2013·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·David Y GrahamMing-Shiang Wu
May 23, 2012·Gastroenterology·David Y Graham, Akiko Shiotani
May 10, 2013·Alimentary Pharmacology & Therapeutics·F SierraA Cárdenas
Sep 20, 2011·Helicobacter·David Y Graham, Maria P Dore
Mar 13, 2012·Alimentary Pharmacology & Therapeutics·J P Gisbert
Mar 13, 2012·Alimentary Pharmacology & Therapeutics·D Y Graham, L A Fischbach
Apr 15, 2016·Expert Review of Anti-infective Therapy·David Y Graham, Maria Pina Dore
Nov 12, 2015·World Journal of Gastrointestinal Pharmacology and Therapeutics·Shen-Shong Chang, Hsiao-Yun Hu
Feb 5, 2011·Nature Reviews. Gastroenterology & Hepatology·Emiko RimbaraDavid Y Graham
Jul 15, 2017·Journal of Pharmacology & Pharmacotherapeutics·Sahoo AshokkumarVikram Kate
Jul 10, 2019·Helicobacter·Adrian G McNichollUNKNOWN As Scientific Committee of the Hp-Eureg on Behalf of the National Coordinators
May 4, 2017·Helicobacter·Javier P Gisbert, Adrian G McNicholl
Apr 7, 2018·Therapeutic Advances in Chronic Disease·Xavier Calvet
May 9, 2019·The Canadian Journal of Infectious Diseases & Medical Microbiology = Journal Canadien Des Maladies Infectieuses Et De La Microbiologie Médicale·Maria Pina DoreDavid Y Graham
Nov 6, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Javier P Gisbert

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