Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 14, 2024; 30(6): 556-564
Published online Feb 14, 2024. doi: 10.3748/wjg.v30.i6.556
Optimized sequential therapy vs 10- and 14-d concomitant therapy for eradicating Helicobacter pylori: A randomized clinical trial
Hassan Seddik, Jihane Benass, Sanaa Berrag, Asmae Sair, Reda Berraida, Hanae Boutallaka
Hassan Seddik, Jihane Benass, Asmae Sair, Reda Berraida, Hanae Boutallaka, Department of Gastroenterology II, Mohammed V Military Teaching Hospital of Rabat, Rabat 10100, Morocco
Hassan Seddik, Jihane Benass, Sanaa Berrag, Asmae Sair, Reda Berraida, Hanae Boutallaka, Department of Gastroenterology, Mohammed V University in Rabat, Rabat 10100, Morocco
Sanaa Berrag, Department of Gastroenterology I, Mohammed V Military Teaching Hospital of Rabat, Rabat 10100, Morocco
Author contributions: Seddik H was responsible for study concept and planning and supervised the statistical analysis and manuscript revision; Benass J and Boutallaka H were involved in performing the statistical analysis and writing the manuscript, with input from all authors; Berrag S, Sair A, and Berraida R were involved in patient enrollment and data collection and were involved in manuscript preparation; All authors reviewed the manuscript.
Institutional review board statement: An Institutional Review Board (Scientific committee at Mohammed V Military Teaching Hospital of Rabat) reviewed and approved the trial protocol. Our study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.
Clinical trial registration statement: Our clinical trial has been retrospectively registered in the Pan African Clinical Trial Registry (www.pactr.org) on December 7, 2021, Registration No.: PACTR202112632957229.
Informed consent statement: All patients included in the study provided written informed consent before being enrolled in the trial.
Conflict-of-interest statement: The authors report having no relevant conflicts of interest for this article.
Data sharing statement: The datasets generated and/or analyzed during the study are available from the corresponding author on reasonable request.
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 Non-Commercial (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: Jihane Benass, MD, Senior Resident, Department of Gastroenterology II, Mohammed V Military Teaching Hospital of Rabat, Avenue des Forces Armées Royales, Rabat 10100, Morocco. jihane.benass@gmail.com
Received: October 6, 2023
Peer-review started: October 6, 2023
First decision: November 12, 2023
Revised: November 26, 2023
Accepted: December 29, 2023
Article in press: December 29, 2023
Published online: February 14, 2024
ARTICLE HIGHLIGHTS
Research background

A cure for Helicobacter pylori (H. pylori) remains a problem of global concern and none of the currently available treatments can achieve a cure rate of 100%. With the global rising issue of antibiotic resistance and the difficulty to establish personalized treatments according to antibiotic susceptibility in developing countries, optimizing sequential therapy seems to be one of the most attractive strategies in terms of efficacy, tolerability and cost.

Research motivation

H. pylori eradication rate is significantly influenced by antibiotic resistance. According to the Maastricht VI consensus, the most recommended empirical regimens for H. pylori infection are Bismuth quadruple therapy and non-Bismuth quadruple concomitant therapy when the Bismuth agent is not available. Many studies showed that switching to high doses of second-generation proton-pump inhibitors (PPIs) and using a PPI-amoxicillin dual therapy can improve the eradication rate and could lead to fewer adverse effects (AEs). The cost of treatment is also a determining factor, especially in developing countries.

Research objectives

In the present study, we aimed to compare the results of the standard 10- and 14-d non-bismuth quadruple therapies to an optimized sequential therapy by using a second-generation PPI, in terms of efficacy, tolerability and cost-effectiveness. The 14-d sequential therapy using rabeprazole appears to be an optimal therapy that is comparable to 14-d concomitant therapy while causing fewer AEs and allowing a gain in terms of cost. Other studies could further validate the standard eradication regimens vs the 14-d sequential therapy using rabeprazole vs other regimens containing vonoprazan. For the moment, this molecule is still not available in Morocco.

Research methods

We conducted a single center, prospective, open-label, randomized study with patients randomly assigned into three groups in a 1:1:1 ratio using a computer-generated table: QT-14, QT-10 and OST-14. Allocations were concealed in a sealed opaque envelope to be opened during the consultation day.

Research results

This study showed that the 14-d sequential therapy using rabeprazole appears to be an optimal therapy that is comparable to 14-d concomitant therapy while causing fewer AEs and allowing a gain in terms of cost.

Research conclusions

According to the Maastricht VI consensus, the most recommended empirical regimens for H. pylori infection are Bismuth quadruple therapy and non-Bismuth quadruple concomitant therapy. This study suggests the use of an optimized 14-d sequential regimen using rabeprazole to achieve the same eradication rate as the non-bismuth quadruple concomitant therapy while leading to fewer AEs and being more economically attractive.

Research perspectives

Given our study’s limitations, these are several future research perspectives: (1) Conduct a multicenter trial (in different geographical areas) to validate our results; (2) Compare the sequential therapy to other therapies containing vonoprazan; and (3) Compare the use of esomeprazole and rabeprazole in a sequential therapy in terms of efficacy, tolerability and cost-effectiveness.