g., Escherichia coli urinary tract infections, pneumococcal pneumonia, gonorrhea, tuberculosis) increases and success declines to unacceptable levels, new regimens are introduced. Few would consider or recommend comparing the new highly successful regimen with a previous “locally best” or “tradition” in which resistance had undermined success (i.e., there would be no need to “prove” that the new regimen was “better” than one that was known to be no longer acceptable locally). However, this seemingly unimaginable scenario
occurs often in anti-H. pylori clinical trials. Not only are good and bad anti-H. pylori therapies compared but also the results are then subjected to meta-analyses, which only prove that what was known to a bad regimen
is reliably bad [3]. It NVP-LDE225 is unethical to enter subjects into a trial using a known inferior regimen [2]. It is also unethical to withhold full information from the subject regarding current effectiveness of a regimen even if that information would reduce the likelihood that anyone would volunteer (i.e., an inferior regimen can never be called the “standard of care” or “approved” in lieu of telling the truth about the actual expected outcome). As 100% success can be achieved, 100% success is a comparator of choice with therapies being judged in terms of how close they come to achieving that level of success. If the best local therapy PF-02341066 in vitro provides unacceptable low cure rates, it should be abandoned just as was single-drug therapy for tuberculosis or low-dose penicillin for pneumonia or Dipeptidyl peptidase syphilis. We do not suggest that comparisons between regimens should never be performed, rather comparisons should be restricted to known good therapies (i.e., to identify the best in terms of outcome, cost, convenience, side effects,
etc.). One only needs to know the success rates for a H. pylori regimen and its components, in relation to the presence of resistance and the level of resistance locally to be able to predict the range of possible outcomes. For example, with legacy triple therapy consisting of a proton pump inhibitor (PPI), clarithromycin, and amoxicillin, the data needed are as follows: the cure rate for the three-drug combination and each of the two dual therapies (i.e., PPI–clarithromycin and PPI–amoxicillin). As amoxicillin resistance is extremely rare, one only needs to know the rates for the triple therapy and the PPI–amoxicillin dual component (Table 2). In the majority of cases, the overall effect is related to the triple component. For example, with 20% clarithromycin resistance, the cure with 14-day triple would be the success with susceptible strains plus the success with clarithromycin-resistant strains.