A randomized controlled trial to compare Helicobacter pylori eradication rates between the empirical concomitant therapy and tailored therapy based on 23S rRNA point mutations. Issue 33 (19th August 2022)

• Record Type: Journal Article
• Authors: Kim, Su Jin; Jee, Sam Ryong; Park, Moo In; Jung, Kyoungwon; Kim, Gwang Ha; Lee, Moon Won; Lee, Jin; Jang, Jin Seok; Koh, Myeongseok
• Other Names: other.
• Is Part Of: Medicine. Volume 101:Issue 33(2022)
• Page Start: e30069
• Publication Date: 2022-08-19
• Subjects: clarithromycin resistance -- concomitant therapy -- eradication rate -- Helicobacter pylori -- polymerase chain reaction -- tailored therapy; Medicine -- Periodicals; Medicine -- Periodicals; Médecine -- Périodiques; Geneeskunde; Medicine; Periodicals; Periodicals; 610.5
• DOI: 10.1097/MD.0000000000030069
• Languages: English
• ISSNs: 0025-7974

Abstract

Abstract : Background: Increasing clarithromycin resistance has led to changes in several guidelines for treatment of Helicobacter pylori infections. We compared the H. pylori eradication rates of the empirical concomitant therapy (CoT) and a tailored therapy (TaT) using dual-priming oligonucleotide-based polymerase chain reaction to detect mutations in the 23S rRNA gene that are related to clarithromycin resistance. Methods: Between June 2020 and May 2021, 290 patients were enrolled and randomly assigned to 2 groups. In the CoT group, the patients received rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 14 days. In the TaT group, point mutation-negative patients received rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 14 days and point mutation-positive patients received rabeprazole 20 mg twice daily, metronidazole 500 mg thrice daily, and bismuth 120 mg and tetracycline 500 mg 4 times daily for 14 days. Results: A total of 290 and 261 patients were included in the intention-to-treat (ITT) and per-protocol (PP) analyses, respectively. A2142G and/or A2143G point mutations were identified in 28.6% of the patients. No significant difference in eradication rates were observed between the 2 groups as per ITT (CoT, 82.8% and TaT, 85.5%, P = .520) and PP (CoT, 88.6% and TaT, 94.6%, P = .084) analyses. In point mutation-positive patients, the eradication rates in the CoT group were lower than those in the TaT group as per ITT (69.8% and 87.5%, respectively, P = .050) and PP (76.9% and 97.1%, respectively, P = .011) analyses. Conclusion: CoT and TaT showed similar overall eradication rates for H. pylori . However, CoT eradication rate was suboptimal, especially in point mutation-positive patients.