Case Control Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 21, 2021; 27(31): 5247-5258
Published online Aug 21, 2021. doi: 10.3748/wjg.v27.i31.5247
Tailored eradication strategy vs concomitant therapy for Helicobacter pylori eradication treatment in Korean patients
Youn I Choi, Jun-Won Chung, Kyoung Oh Kim, Kwang An Kwon, Yoon Jae Kim, Jung Ho Kim, Ja Young Seo, Dong Kyun Park
Youn I Choi, Jun-Won Chung, Kyoung Oh Kim, Kwang An Kwon, Yoon Jae Kim, Jung Ho Kim, Dong Kyun Park, Division of Internal Medicine, Department of Gastroenterology, Gachon University College of Medicine, Gil Medical Center, Inchoen 21565, South Korea
Ja Young Seo, Department of Laboratory Medicine, Gil Medical Center, Gachon University, Inchoen 21565, South Korea
Dong Kyun Park, Health IT Research Center, Gachon University Gil Hospital, Incheon 21565, South Korea
Author contributions: Chung JW contributed to the study concept and design, coordinated all of the study processes as the corresponding authors; Choi YI and Seo JY analyzed the data; Choi YI interpreted the data; Choi YI and Chung JW drafted the manuscript; Park DK, Kim KO, Kwon KA, Kim JH, and Kim YJ critically revised the manuscript for important intellectual content; all the authors approved the submitted draft.
Supported by National Research Foundation of Korea (NRF) funded by the Ministry of Education, No. NRF-2020R1F1A1076839.
Institutional review board statement: The Institutional Review Board of the Gil Medical Center (GMC) 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 the GMC.
Informed consent statement: Patients were not required to give the informed consent to the study because the analysis used the anonymous data that were collected after each patient agreed to treatment.
Conflict-of-interest statement: All the Authors have no conflict of interest related to the manuscript.
Data sharing statement: The data used to support the findings of this study are available from the corresponding author upon request at (junwonchung@gilhospital.com)
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 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: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jun-Won Chung, MD, PhD, Professor, Division of Internal Medicine, Department of Gastroenterology, Gachon University College of Medicine, Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon 21565, South Korea. junwonchung@hanmail.net
Received: April 29, 2021
Peer-review started: April 29, 2021
First decision: June 3, 2021
Revised: July 9, 2021
Accepted: July 29, 2021
Article in press: July 29, 2021
Published online: August 21, 2021
Processing time: 111 Days and 1.9 Hours
Abstract
BACKGROUND

Antibiotic resistance to Helicobacter pylori (H. pylori) infection, which ultimately results in eradication failure, has been an emerging issue in the clinical field. Recently, to overcome this problem, an antibiotic sensitivity-based tailored therapy (TT) for H. pylori infection has received attention.

AIM

To investigate the efficacy and safety profiles of TT for H. pylori infection treatment compared to a non-bismuth quadruple therapy, concomitant therapy (CT) regimen.

METHODS

We included patients (> 18 years) with an H. pylori infection and without a history of Helicobacter eradication who visited the Gil Medical Center between March 2016 and October 2020. After being randomly assigned to either the TT or CT treatment group in 1 to 1 manner, patient compliance, eradication success rate (ESR), and patient-reported side effects profiles were assessed and compared between the two groups. H. pylori infection was diagnosed using a rapid urease test, Giemsa stain, or dual priming oligonucleotide polymerase chain reaction (DPO-PCR). Tailored eradication strategy based through the presence of a 23S ribosomal RNA point mutation. For the TT group, a DPO-PCR test, which detected A2142G and/or A2143G point mutations, and a clarithromycin resistance test were performed. Patients in the clarithromycin-resistant group were treated with a bismuth-containing quadruple combination therapy, while those with sensitive results were treated with the standard triple regimen.

RESULTS

Of the 217 patients with a treatment naive H. pylori infection, 110 patients [mean age: 58.66 ± 13.03, men, n = 55 (50%)] were treated with TT, and 107 patients [mean age: 56.67 ± 10.88, men, n = 52 (48.60%)] were treated with CT. The compliance (TT vs CT, 100% vs 98.13%, P = 0.30), and follow-up loss rates (8.18% vs 9.35%, P = 0.95) were not significantly different between the groups. The ESR after treatment was also not statistically different between the groups (TT vs CT, 82.73% vs 82.24%, P = 0.95). However, the treatment-related and patient-reported side effects were significantly lower in the TT group than in the CT group (22.77% vs 50.52%, P < 0.001).

CONCLUSION

The DPO-based TT regimen shows promising results in efficacy and safety profiles as a first-line Helicobacter eradication regimen in Korea, especially when physicians are confronted with increased antibiotic resistance rates.

Keywords: Helicobacter pylori; Eradication; Tailored therapy; Concomitant therapy regimen

Core Tip: We investigated the efficacy and safety profiles of a tailored therapy (TT) as a first line Helicobacter pylori (H. pylori) eradication treatment compared to a concomitant therapy (CT) regimen in Korea, where clarithromycin resistance rates are high. Of 217 treatment-naïve H. pylori infection patients, 107 patients were treated with CT and 101 patients with TT. Although the eradication success rate was not statistically different between the groups, the treatment-related side effect rate was significantly lower in the TT group. Therefore, the TT regimen might be a promising solution to overcoming the problem of increased antibiotic resistance rates for Helicobacter eradication.