Empirical Therapy Versus Tailored Therapy of Helicobacter pylori in Korea: Results of the K‐CREATE Study

ABSTRACT Background The optimal duration of regimens for tailored therapy based on genotypic resistance for clarithromycin has yet to be established. Aim This study was a nationwide, multicenter, randomized trial comparing empirical therapy with tailored therapy based on genotypic resistance for first‐line eradication of Helicobacter pylori . We also compared the eradication rates of 7‐ and 14‐day regimens for each group. Patients and Methods Patients with H. pylori infection were first randomized to receive empirical or tailored therapy. Patients in each group were further randomized into 7‐ or 14‐day regimens. Empirical therapy consisted of a triple therapy (TT) regimen (twice‐daily doses of pantoprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg) for 7 or 14 days. Tailored therapy consisted of TT of 7 or 14 days in patients without genotypic resistance. Patients with genotypic resistance were treated with bismuth quadruple therapy (BQT) regimens (twice‐daily doses of pantoprazole 40 mg, three daily doses of metronidazole 500 mg, and four times daily doses of bismuth 300 mg and tetracycline 500 mg) for 7 or 14 days. A 13 C‐urea breath test assessed eradication rates. The primary outcome was eradication rates of each group. Results A total of 593 patients were included in the study. The eradication rates were 65.7% (201/306) in the empirical therapy group and 81.9% (235/287) in the tailored therapy group for intention‐to‐treat analysis ( p < 0.001). In the per‐protocol analysis, the eradication rates of the empirical therapy and tailored groups were 70.3% (201/286) and 85.5% (235/274) ( p < 0.001), respectively. There was no difference in compliance between the two groups. The rate of adverse events was higher in the tailored group compared to the empirical group ( p < 0.001). Discussion Our study confirmed that tailored therapy based on genotypic resistance was more effective than empirical therapy for H. pylori eradication in Korea. However, no significant difference was found between 7‐ and 14‐day regimens for each group. Future studies are needed to determine the optimal duration of therapy for empirical and tailored therapy regimens.