Comparison of Empirical and Genotypic Resistance-Guided Tailored Therapy for Helicobacter pylori Infection: A Randomized Controlled Trial.

Background/Aims We investigated to compare the effect of empirical therapy versus genotypic resistance-guided tailored therapy (tailored therapy) for eradication of Helicobacter pylori infection. Methods In this prospective, single center, open-label randomized controlled trial, we enrolled 72 patients with H. pylori infection from January 2019 through June 2019 in South Korea. The patients were randomly assigned to both groups received empirical therapy (n=36) or tailored therapy (n=36). Empirical therapy was defined as triple therapy with esomeprazole, amoxicillin, and clarithromycin for 10 days irrespective of clarithromycin resistance. Tailored therapy was triple therapy or quadruple therapy with esomeprazole, metronidazole, tetracycline, and bismuth for 10 days based on genotype markers of resistance determined by gastric biopsy specimens. Resistance-associated mutations in 23S ribosomal RNA were confirmed by multiplex polymerase chain reaction (PCR). Eradication status was assessed by 13C-urea breath test and the primary outcome was eradication rate. Results H. pylori was eradicated in 27 of 36 patients (75.0%) given empirical therapy and 32 of 36 patients (88.9%) treated with tailored therapy (p=0.136) in intention-to-treat analysis. In per-protocol analysis, H. pylori was eradicated in 32 of 33 (97.0%) patients receiving tailored therapy and 27 of 33 (81.8%) patients with empirical therapy (p=0.046). While clarithromycin resistant H. pylori was eradicated in three of nine (33.3%) with empirical therapy, it was treated in 11 out of 12 (91.7%) with tailored therapy (p=0.009). There was no difference in compliance between two groups. Rate of adverse events of tailored group was higher than that of empirical therapy (p=0.036) since quadruple therapy group had more side effects than triple therapy group (p=0.001). Conclusions Genotype resistance-guided tailored therapy based on PCR is a good alternative to increase the eradication rate. [ABSTRACT FROM AUTHOR]