Prospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jun 6, 2024; 12(16): 2773-2779
Published online Jun 6, 2024. doi: 10.12998/wjcc.v12.i16.2773
Helicobacter pylori: High dose amoxicillin does not improve primary or secondary eradication rates in an Irish cohort
Conor Costigan, Aoife M O'Sullivan, Jim O'Connell, Shreyashee Sengupta, Thomas Butler, Stephen Molloy, Fintan John O'Hara, Barbara Ryan, Niall Breslin, Sarah O'Donnell, Anthony O'Connor, Sinead Smith, Deirdre McNamara
Conor Costigan, Thomas Butler, Stephen Molloy, Sinead Smith, Deirdre McNamara, Trinity Academic Gastroenterology Group, School of Medicine-Trinity College Dublin, Dublin D2, Ireland
Conor Costigan, Aoife M O'Sullivan, Jim O'Connell, Shreyashee Sengupta, Fintan John O'Hara, Barbara Ryan, Niall Breslin, Sarah O'Donnell, Anthony O'Connor, Deirdre McNamara, Department of Gastroenterology, Tallaght University Hospital, Dublin D24 NR0A, Ireland
Author contributions: Costigan C and McNamara D contributed to study design, patient recruitment, data analysis, and writing of manuscript; Smith S contributed to study design, data analysis, writing of manuscript; O'Sullivan AM, O'Connell J, Sengupta S, O'Hara FJ, Ryan B, Breslin N, O'Donnell S, O'Connor A and Smith S contributed to patient recruitment and data collection; Butler T and Molloy S contributed to data collection, data analysis and manuscript review. All authors have read and approved the manuscript.
Institutional review board statement: Study approved as a quality improvement initiative by the SJH/TUH Joint Research Ethics Committee (Project No. 3364).
Clinical trial registration statement: This prospective study was assessed by local hospital ethics committee and approved as a quality improvement initiative by the SJH/TUH Joint Research Ethics Committee (Project No. 3364). A such it did not require registration as a clinical trial.
Informed consent statement: All subjects understood and agreed to the study protocol and voluntarily signed the informed consent form.
Conflict-of-interest statement: The authors declare no conflict of interests.
Data sharing statement: Data sharing agreement approved as part of SJH/TUH Joint Research Ethics Committee (Project ID 3364).
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Conor Costigan, BM BCh, Assistant Professor, Doctor, Lecturer, Trinity Academic Gastroenterology Group, School of Medicine-Trinity College Dublin, Centre for Learning and Development Tallaght University Hospital Dublin 24, Dublin D2, Ireland. conorcostigan92@gmail.com
Received: January 4, 2024
Revised: February 8, 2024
Accepted: April 7, 2024
Published online: June 6, 2024
Processing time: 146 Days and 1.7 Hours
Abstract
BACKGROUND

Helicobacter pylori (H. pylori) eradication rates have fallen globally, likely in large part due to increasing antibiotic resistance to traditional therapy. In areas of high clarithromycin and metronidazole resistance such as ours, Maastricht VI guidelines suggest high dose amoxicillin dual therapy (HDADT) can be considered, subject to evidence for local efficacy. In this study we assess efficacy of HDADT therapy for H. pylori eradication in an Irish cohort.

AIM

To assess the efficacy of HDADT therapy for H. pylori eradication in an Irish cohort as both first line, and subsequent therapy for patients diagnosed with H. pylori.

METHODS

All patients testing positive for H. pylori in a tertiary centre were treated prospectively with HDADT (amoxicillin 1 g tid and esomeprazole 40 mg bid × 14 d) over a period of 8 months. Eradication was confirmed with Urea Breath Test at least 4 wk after cessation of therapy. A delta-over-baseline > 4% was considered positive. Patient demographics and treatment outcomes were recorded, analysed and controlled for basic demographics and prior H. pylori treatment.

RESULTS

One hundred and ninety-eight patients were identified with H. pylori infection, 10 patients were excluded due to penicillin allergy and 38 patients refused follow up testing. In all 139 were included in the analysis, 55% (n = 76) were female, mean age was 46.6 years. Overall, 93 (67%) of patients were treatment-naïve and 46 (33%) had received at least one previous course of treatment. The groups were statistically similar. Self-reported compliance with HDADT was 97%, mild side-effects occurred in 7%. There were no serious adverse drug reactions. Overall the eradication rate for our cohort was 56% (78/139). Eradication rates were worse for those with previous treatment [43% (20/46) vs 62% (58/93), P = 0.0458, odds ratio = 2.15]. Age and Gender had no effect on eradication status.

CONCLUSION

Overall eradication rates with HDADT were disappointing. Despite being a simple and possibly better tolerated regime, these results do not support its routine use in a high dual resistance country. Further investigation of other regimens to achieve the > 90% eradication target is needed.

Keywords: Helicobacter pylori eradication; Helicobacter pylori; High dose amoxicillin; High dose amoxicillin dual therapy; Triple therapy

Core Tip: We present a prospective assessment of high dose amoxicillin dual therapy (HDADT) for Helicobacter pylori in an Irish cohort. Ireland is a 'high dual-resistance country'-(clarithromycin and metronidazole)-mainstays of traditional treatment. Where bismuth-based therapy is unavailable, as in Ireland, European guidelines recommend HDADT can be considered. This is the first data on HDADT to date in Ireland, and despite promising data from Asia, European data remains scant. Our results show disappointing eradication rates; we discuss possible reasons why and provide clinical evidence to authorities for the need to make bismuth-therapy available in our country. We advise against HDADT in European populations.