Key Points for Designing and Reporting Helicobacter pylori Therapeutic Trials: A Personal View

Background & objectives: The aim of this document is to provide a methodological framework and to review key aspects for adequately designing trials to evaluate new treatments for Helicobacter pylori infection. Methods: Non-systematic literature review. Results & conclusions: Regarding the design of the article, we suggest selecting for future trials drugs to which H. pylori has no significant primary resistances and evaluating therapies with pilot studies before engaging in randomized trials. The manuscript defines how the number and type of H. pylori diagnostic tests necessary before and after the trial depend on the setting and reliability of the tests. It recommends the best methods and timing for H. pylori testing before and after therapy. Other recommendations are using current standard treatments as comparators of new therapies, determining antibiotic sensitivity - whenever useful and possible - using adequate randomization and allocation concealment but not necessarily blinding, and performing an intention-to-treat and a per-protocol analysis. In addition, we give basic tips for reporting and discussing study results.