Illusions regarding Helicobacter pylori clinical trials and treatment guidelines

• Published in: Gut Vol. 66; no. 12; pp. 2043 - 2046
• Main Author: Graham, David Y
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.12.2017
• Subjects: Anti-Bacterial Agents - therapeutic use; Antibiotic resistance; Antibiotics; Clarithromycin; Clinical trials; Clinical Trials as Topic - standards; Drug Resistance, Bacterial; Drugs; Ethics; Failure; Helicobacter Infections - drug therapy; Helicobacter pylori; Humans; Infections; Infectious diseases; Meta-analysis; Microbial Sensitivity Tests; Population studies; Practice Guidelines as Topic; Proton Pump Inhibitors - therapeutic use; Studies; Systematic review; Urogenital system; susceptibility testing; Helicobacter pylori; meta-analyses; antibiotic resistance; optimized; therapy; shmeta-analysis; illusions
• ISSN: 0017-5749; 1468-3288
• DOI: 10.1136/gutjnl-2017-314744

Development of H. pylori therapy differs from other infectious diseases. Since the advent of antibiotics, infectious diseases therapy has been susceptibility based, whereas most H. pylori treatment guidelines recommend susceptibility testing only after two empiric therapy failures. The susceptibility of etiologic bacteria is almost never known at the time an infected patient is enrolled in a clinical trial that evaluates initial antimicrobial treatment. [...]the comparator drugs chosen for study in antibacterial clinical trials are selected because they are anticipated to be effective against all, or almost all, strains likely to be encountered during conduct of the study. The differences between regimens relate to differences in the prevalence of clarithromycin resistance in the population (range 0% to 20%). Because the trial results are population specific, they were not generalisable. Comparisons among trials where differences are dependent on the presence of antibiotic resistance populations are invalid. Because study-specific results cannot be generalised, they should not be published, quoted nor used for meta-analyses.