Comparison of Therapeutic Outcomes Between Concomitant Therapy and Tailored Therapy for Helicobacter pylori: A Multicenter, Prospective, and Randomized Study

ABSTRACT Background The increasing trend of clarithromycin resistance in Helicobacter pylori ( H. pylori ) is the primary cause of failure of standard triple therapy. Concomitant therapy is recommended as an alternative in regions with high rates of clarithromycin resistance. Recently, tailored therapies based on resistance testing have emerged as viable treatment approaches. We aimed to compare the eradication rates and adverse effects of concomitant and tailored therapies. Materials and Methods We enrolled 319 patients diagnosed with H. pylori infection using dual‐priming oligonucleotide (DPO) polymerase chain reaction (PCR) tests conducted in six hospitals across the Daejeon and Chungcheong regions of Korea. Based on DPO‐PCR results, patients were randomly assigned to either the concomitant therapy group (non‐bismuth quadruple therapy) or the tailored therapy group (standard triple therapy for clarithromycin‐sensitive cases and bismuth quadruple therapy for clarithromycin‐resistant cases). Demographics, eradication success rates, adverse effects, and patient compliance were assessed. Data were analyzed using modified intention‐to‐treat (mITT) and per‐protocol (PP) analyses. Results The eradication rate was significantly higher in the tailored therapy group than in the concomitant therapy group in PP analysis (92.62% vs. 85.21%, p = 0.026). The severity of adverse effects was significantly greater in the concomitant therapy group than in the tailored therapy group ( p = 0.025). Conclusion Considering the high eradication success rate and low severity of adverse effects, tailored therapy based on DPO‐PCR is preferable to concomitant therapy without resistance testing for the treatment of H. pylori infection. Trial Registration Clinical Research Information Service (CRIS): KCT0004162