In search of the Holy Grail of Heliocobacter pylori remedies.
In this issue, Gisbert et al. (pp. 157-62) present the results of a noncomparative study evaluating a twice daily, 5-day regimen of ranitidine bismuth citrate, amoxicillin, clarithromycin and metronidazole twice daily for Helicobacter pylori cure. This study is one of a few stuides that evaluate a 5-day triple antimicrobial regimen in combination with a antisecretory agent. Although the study design precludes making any definite conclusion, it does encourage additional investigation of these types of regimens. Randomized controlled trials (RCTs) using regimens containing multiple agents should consider both standard-of-care comparator regimens and comparator regimens that will provide a better understanding of why regimens are more effective or better tolerated. The goal of treatment should be to maintain a lower bound 95% confidence interval (CI) of the point estimate of greater than 80% and a 'delta' (lower bound 95% CI of the difference in rates) of less than 10%. All RCTs should conduct susceptibility testing to evaluate the impact of resistance on efficacy and explain eradication failures. Finally, consideration should be given to the inclusion of patients with functional dyspepsia in H. pylori studies evaluating H. pylori cure since patients with peptic ulcer disease are becoming harder to find.
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D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D017291:Clarithromycin; D001729:Bismuth