Helicobacter pylori therapy demystified

We discuss the role of comparators in Helicobacter pylori treatment trials and
why anti-H. pylori therapeutic trials (an infectious disease) are fundamentally
different from common gastrointestinal diseases (e.g., the absence of a
placebo response, the expectation that cure rates in excess of 95%, and the
ability to understand why treatment fails). No comparator is absolutely
required other than to 100% success and comparison trials should be limited
to comparisons between therapies that reliably achieve 90% or greater success
(i.e., good therapies). Comparisons with known low success regimens
(i.e., bad therapies) are unethical as is withholding information from the
subject regarding current effectiveness of a regimen even if that information
would reduce the likelihood that the subject would volunteer. We also discuss
how it is possible to predict the outcome of a published but locally
untried new regimen. The reason for different outcomes of typical gastrointestinal
therapies is shrouded in mystery. In contrast, treatment success for
H. pylori should be predictable and treatment failures explainable. For too
long expectations and analyses of H. pylori therapy has been confused with
what is appropriate for gastrointestinal disease such as constipation or irritable
bowel syndrome rather than for infectious diseases such as pneumonia.