14-day Empirical Therapy Compared with 7-day Tailored Therapy for Helicobacter pylori Eradication in Korea: Results of the K-CREATE Phase II Study

Purpose: There are ongoing debates regarding whether tailored therapy based on genotypic resistance can reduce treatment duration compared to empirical therapy. This study was a nationwide, multi-center, randomized trial conducted in Korea to compare the efficacy of 14-day empirical therapy with 7-day tailored therapy as a first-line treatment for Helicobacter pylori (H. pylori) eradication. Materials and Methods: Patients were randomized to receive either 14-day empirical therapy or 7-day tailored therapy based on genotypic resistance. The empirical therapy consisted of a clarithromycin-based triple therapy (TT) regimen (twice-daily doses of pantoprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg). Tailored therapy involved a 7-day TT in patients without genotypic resistance, while those with resistance received a 7-day bismuth quadruple therapy regimen (twice-daily doses of pantoprazole 40 mg, three-times-daily doses of metronidazole 500 mg, and four-times-daily doses of bismuth 300 mg and tetracycline 500 mg). Eradication rates were assessed using the¹³C-urea breath test. The primary outcome was the eradication rate in each group. Results: A total of 102 patients were enrolled. In the intention-to-treat analysis, eradication rates were 65.5% in the empirical therapy group and 82.9% in the tailored therapy group (p=0.076). In the per-protocol analysis, eradication rates were 67.9% and 86.7%, respectively (p=0.052). There was no significant difference in patient compliance between the two groups. Conclusion: This study demonstrated that tailored therapy based on genotypic resistance may reduce treatment duration compared to empirical therapy in the eradication of H. pylori in Korea.