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Bismuth-Based Quadruple Therapy versus Metronidazole-Intensified Triple Therapy as a First-Line Treatment for Clarithromycin-Resistant Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial.


ABSTRACT:

Background/aims

Clarithromycin resistance is a main factor for treatment failure in the context of Helicobacter pylori infection. However, the treatment regimen for clarithromycin-resistant H. pylori infection has not yet been determined. We aimed to compare the efficacy and cost-effectiveness of 14-day bismuth-based quadruple therapy versus 14-day metronidazole-intensified triple therapy for clarithromycin-resistant H. pylori infection with genotypic resistance.

Methods

This was a multicenter, randomized, controlled trial. A total of 782 patients with H. pylori infection examined using sequencing-based clarithromycin resistance point mutation tests were recruited between December 2018 and October 2020 in four institutions in Korea. Patients with significant point mutations (A2142G, A2142C, A2143G, A2143C, and A2144G) were randomly assigned to receive either 14-day bismuth-based quadruple therapy (n=102) or 14-day metronidazole-intensified triple therapy (n=99).

Results

The overall genotypic clarithromycin resistance rate was 25.7% according to the sequencing method. The eradication rate of 14-day bismuth-based quadruple therapy was not significantly different in the intention-to-treat analysis (80.4% vs 69.7%, p=0.079), but was significantly higher than that of 14-day metronidazole-intensified triple therapy in the per-protocol analysis (95.1% vs 76.4%, p=0.001). There were no significant differences in the incidence of side effects. In addition, the 14-day bismuth-based quadruple therapy was more cost-effective than the 14-day metronidazole-intensified triple therapy.

Conclusions

Fourteen-day bismuth-based quadruple therapy showed comparable efficacy with 14-day metronidazole-intensified triple therapy, and it was more cost-effective in the context of clarithromycin-resistant H. pylori infection.

SUBMITTER: Seo SI 

PROVIDER: S-EPMC9474493 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Bismuth-Based Quadruple Therapy versus Metronidazole-Intensified Triple Therapy as a First-Line Treatment for Clarithromycin-Resistant <i>Helicobacter pylori</i> Infection: A Multicenter Randomized Controlled Trial.

Seo Seung In SI   Lim Hyun H   Bang Chang Seok CS   Yang Young Joo YJ   Baik Gwang Ho GH   Lee Sang Pyo SP   Jang Hyun Joo HJ   Kae Sea Hyub SH   Kim Jinseob J   Kim Hak Yang HY   Shin Woon Geon WG  

Gut and liver 20220211 5


<h4>Background/aims</h4>Clarithromycin resistance is a main factor for treatment failure in the context of <i>Helicobacter pylori</i> infection. However, the treatment regimen for clarithromycin-resistant <i>H. pylori</i> infection has not yet been determined. We aimed to compare the efficacy and cost-effectiveness of 14-day bismuth-based quadruple therapy versus 14-day metronidazole-intensified triple therapy for clarithromycin-resistant <i>H. pylori</i> infection with genotypic resistance.<h4>  ...[more]

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