Retrospective Cohort Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 14, 2019; 25(46): 6743-6751
Published online Dec 14, 2019. doi: 10.3748/wjg.v25.i46.6743
Tailored eradication vs empirical bismuth-containing quadruple therapy for first-line Helicobacter pylori eradication: A comparative, open trial
Youn I Choi, Jun Won Chung, Dong Kyun Park, Kyoung Oh Kim, Kwang An Kwon, Yoon Jae Kim, Ja Young Seo
Youn I Choi, Jun Won Chung, Dong Kyun Park, Kyoung Oh Kim, Kwang An Kwon, Yoon Jae Kim, Department of Gastroenterology, Gil Medical Center, Gachon University, Incheon 21565, South Korea
Ja Young Seo, Department of Laboratory Medicine, Gil Medical Center, Gachon University, Incheon 21565, South Korea
Author contributions: Choi YI, Park DK, and Chung JW contributed to the study concept and design; Choi YI analyzed and interpreted the data; Choi YI, Park DK, and Chung JW drafted the manuscript; Kim KO, Kwon KA, and Kim YJ critically revised the manuscript for important intellectual content. All authors approved the draft submitted.
Institutional review board statement: The Institutional Review Board of Gil Medical Center reviewed the study protocol and ethics. This study was conducted in accordance with the Declaration of Helsinki, and the study protocol was approved by the Ethics Committee of each participating hospital.
Informed consent statement: Our study involved prospectively enrolled patients (open-label and comparative study), and retrospectively reviewed the patients’ data which were usual clinical procedures for diagnosis of Helicobacter pylori infection and treatments. All patients provided informed consent regarding esophagogastroduodenoscopy (EGD), EGD guided biopsy, histopathology test, rapid urease test, Giemsa staining, or dual priming oligonucleotide polymerase chain reaction (DPO-PCR) test, and tailored regimen.
Conflict-of-interest statement: No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.
Data sharing statement: Technical appendix, statistical code, and dataset are available from the corresponding author at: junwonchung@hanmail.net.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article which 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: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Jun Won Chung, MD, PhD, Associate Professor, Doctor, Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, 21 Namdong-daero 774 beon-gil, Namdong-gu, Incheon 21565, South Korea. junwonchung@hanmail.net
Telephone: +82-10-90041604
Received: September 27, 2019
Peer-review started: September 27, 2019
First decision: November 10, 2019
Revised: November 30, 2019
Accepted: December 7, 2019
Article in press: December 7, 2019
Published online: December 14, 2019
Processing time: 78 Days and 1.4 Hours
ARTICLE HIGHLIGHTS
Research background

As the resistance rate for Helicobacter pylori (H. pylori) eradication regimen has been increased worldwide and also in Korea, the strategy to reduce the chance of H. pylori resistance rate is an unmet need.

Research motivation

In general, antibiotic resistance has been attributed to the improper use of antibiotics. In this regard, tailored regimen has recently been introduced for H. pylori eradication. However, few studies have compared the efficacy and safety profile of a TR strategy based on the presence of a 23S ribosomal RNA point mutation with those of EBQT as first-line eradication therapy for H. pylori infection in Korean patients.

Research objectives

To compare the efficacy and safety profile of a TR strategy vs the EBQT regimen as first-line eradication therapy for H. pylori in Korean patients.

Research methods

We prospectively enrolled patients over 18 years of age with H. pylori infection from May 2016 to September 2018 at GMC, conducted an open-label, and comparative study, and retrospectively reviewed the data. H. pylori-positive patients diagnosed by the rapid urease test, Giemsa staining, or dual priming oligonucleotide polymerase chain reaction (DPO-PCR) were enrolled. Patients with H. pylori infection received either a TR regimen or the EBQT regimen. In the tailored therapy group that underwent DPO-PCR testing, patients with A2142G and/or A2143G point mutations were treated with a bismuth-containing quadruple regimen. The eradication rate, patient-reported side effect rate, and H. pylori eradication success rate were evaluated and compared between the groups.

Research results

A total of 150 patients were assigned to the TR (n = 50) or EBQT group (n = 100). The first-line eradication rate of H. pylori did not differ between the groups (96.0% vs 95.7%, P = 0.9). The rate of eradication-related side effects for TR was 12.0%, which differed significantly from that of EBQT (43.0%) for first-line treatment (P < 0.001).

Research conclusions

DPO-PCR-based TR for H. pylori eradication may be equally efficacious, with less treatment-related complications, compared to EBQT as first line eradication regimen in Korea, where clarithromycin (CAM) resistance is high.

Research perspectives

Our study showed that TR is a first-line eradication regimen with non-inferior efficacy and a favorable safety profile compared to bismuth-based quadruple therapy. A future eradication regimen could potentially be designed based on these results for areas where CAM resistance rates are increasing.