Helicobacter pylori eradication rates with concomitant and tailored therapy based on 23S rRNA point mutation: A multicenter randomized controlled trial

Abstract Background We evaluated the efficacy of tailored therapy based on point mutation presence identified with the dual‐priming oligonucleotide (DPO)‐based multiplex polymerase chain reaction (PCR) method compared with concomitant therapy. Materials and methods Subjects were randomly assigned concomitant therapy (amoxicillin 1 g, clarithromycin 500 mg, metronidazole 500 mg, and lansoprazole 30 mg twice/day for 14 days) or tailored therapy (amoxicillin 1 g, clarithromycin 500 mg, and lansoprazole 30 mg twice/day for 14 days in point mutation‐negative subjects; and amoxicillin 1 g, metronidazole 500 mg, and lansoprazole 30 mg twice/day for 14 days in point mutation‐positive subjects). Results A total of 397 and 352 subjects were included in the intention‐to‐treat (ITT) and per‐protocol (PP) analyses, respectively. Point mutations were identified in 25.9% of the subjects. The overall eradication rate was not significantly different between the groups by ITT (86.2% vs 81.6%, P = .132) and PP analyses (90.2% vs 86.5%, P = .179). There was no significant difference in the eradication rates between the groups in both the point mutation‐negative subjects (91.7% vs 87.3%, P = .154) and the point mutation‐positive subjects (71.2% vs 64.7%, P = .312). The eradication rates were significantly lower in the point mutation‐positive subjects than in the point mutation‐negative subjects in both the concomitant and tailored therapy groups. Conclusions Tailored therapy based on point mutation presence identified with the DPO‐based multiplex PCR method was as effective as concomitant therapy. The eradication rates of both therapy regimens were suboptimal in point mutation‐positive subjects.