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

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 perspective [corrected] of an infectious disease with the goal of providing recommendations regarding changes in approach and in reporting that should help resolve the ethical issues and make the results of clinical trials more useful to clinicians.