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PubMed · 42740438

Fourteen-Day Amoxicillin- or Tetracycline-Containing Bismuth Quadruple Therapy versus 14-Day Metronidazole-Based Triple Therapy as the Treatment for Clarithromycin-Resistant Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial.

Myeongseok Koh·Cheol Woong Choi·Dae Gon Ryu·Seung Jung Yu·Sung Eun Kim·Kyoungwon Jung·Bong Eun Lee·Moon Won Lee·Dong Chan Joo·Jin Lee·Ra Ri Cha·Sam Ryong Jee
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Abstract

BACKGROUND/AIMS: Combination therapy comprising a proton pump inhibitor (PPI), amoxicillin, and metronidazole (PAM) is used to treat clarithromycin-resistant Helicobacter pylori in the Republic of Korea, but eradication rates are decreasing due to an increasing incidence of clarithromycin resistance. We compared PAM, bismuth compounds plus PAM (PAM-B), and the combination of PPI, bismuth compounds, metronidazole, and tetracycline (PBMT) to determine whether PAM-B can achieve an eradication rate higher than that of PAM and comparable to that of PBMT. METHODS: This prospective multicenter study enrolled patients with clarithromycin-resistant H. pylori infections in the Busan and Gyeongsangnam-do of the Republic of Korea between December 2022 and February 2024. RESULTS: In the intention-to-treat (ITT) analysis, the eradication rate was significantly lower in the PAM group (68.2%) than in the PAM-B group (84.8%, p=0.024), whereas the difference from the PBMT group (81.8%) was not significant (p=0.070). The rate remained lowest in the PAM group (75.4%) in the per-protocol (PP) analysis (PAM-B, 96.5%, p=0.001; PBMT, 94.6%, p=0.004). Eradication rates were comparable between the PAM-B and PBMT groups in both the ITT (p=0.640) and PP analyses (p=0.633). Nausea and vomiting were significantly less frequent in the PAM-B group than in the PBMT group (6.8% vs 25.0%; p=0.007). Severe adverse events were rare, and all symptoms resolved after treatment discontinuation. CONCLUSIONS: PAM-B yielded eradication rates higher than those of PAM and comparable to those of PBMT, with no significant increase in the incidence of adverse events, suggesting the potential of PAM-B as a first-line treatment for clarithromycin-resistant H. pylori infection. Further large-scale studies are needed to validate these results. Registered retrospectively with the Clinical Research Information Service (CRIS; KCT0012265).

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HumansHelicobacter InfectionsMetronidazoleTetracyclineHelicobacter pyloriBismuthDrug Therapy, CombinationAmoxicillinFemaleClarithromycinAnti-Bacterial AgentsProspective StudiesProton Pump InhibitorsMaleMiddle AgedRepublic of KoreaDrug Resistance, BacterialAdultAgedTreatment OutcomeDrug Administration ScheduleAntibiotic resistanceEradicationJournal ArticleMulticenter StudyRandomized Controlled TrialComparative Study

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Myeongseok Koh, Cheol Woong Choi, Dae Gon Ryu, Seung Jung Yu, Sung Eun Kim, Kyoungwon Jung, Bong Eun Lee, Moon Won Lee, Dong Chan Joo, Jin Lee, Ra Ri Cha, Sam Ryong Jee. 2026-09-15. Fourteen-Day Amoxicillin- or Tetracycline-Containing Bismuth Quadruple Therapy versus 14-Day Metronidazole-Based Triple Therapy as the Treatment for Clarithromycin-Resistant Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial.. https://doi.org/10.5009/gnl250435

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Adult subjectAged subjectAmoxicillin subjectAnti-Bacterial Agents subjectComparative Study subjectDrug Resistance, Bacterial subjectDrug Therapy, Combination subjectFemale subjectHelicobacter Infections subjectHelicobacter pylori subjectHumans subjectJournal Article subjectJournal Article; Multicenter Study; Randomized Controlled Trial; Comparative Study resourceMale subjectMiddle Aged subjectMulticenter Study subject

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