Randomized Controlled Trial
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 14, 2019; 25(46): 6790-6798
Published online Dec 14, 2019. doi: 10.3748/wjg.v25.i46.6790
Two-week bismuth-containing quadruple therapy and concomitant therapy are effective first-line treatments for Helicobacter pylori eradication: A prospective open-label randomized trial
So Jeong Kim, Jun-Won Chung, Hyun Sun Woo, Su Young Kim, Jung Ho Kim, Yoon Jae Kim, Kyoung Oh Kim, Kwang An Kwon, Dong Kyun Park
So Jeong Kim, College of Medicine, Gachon University Graduate School of Medicine, Incheon 21936, South Korea
Jun-Won Chung, Hyun Sun Woo, Jung Ho Kim, Yoon Jae Kim, Kyoung Oh Kim, Kwang An Kwon, Dong Kyun Park, Division of Gastroenterology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon 21565, South Korea
Su Young Kim, Division of Gastroenterology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju 26426, South Korea
Author contributions: Kim SY and Chung JW designed the study; Kim SJ, Woo HS, and Chung JW acquired the data; Kim SJ, Woo HS, and Chung JW analyzed the data and interpreted the results; Kim SJ and Chung JW drafted the manuscript; Chung JW, Kim JH, Kim YJ, Kim KO, Kwon KA, and Park DK revised the manuscript for important intellectual content; Kim SJ and Chung JW performed statistical analysis; Chung JW, Kim JH, Kim YJ, Kim KO, Kwon KA, and Park DK contributed to study supervision; all authors critically reviewed and approved the manuscript.
Institutional review board statement: The Clinical Research Ethics Committee of Gachon University Gil Hospital approved this study.
Clinical trial registration statement: This study is registered at Clinical Research Information Service (CRIS). The registration identification number is KCT0001821.
Informed consent statement: All involved persons gave their written informed consent prior to study inclusion.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: No additional data are available.
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 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: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Jun-Won Chung, MD, PhD, Associate Professor, 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
Received: October 30, 2019
Peer-review started: October 30, 2019
First decision: November 9, 2019
Revised: December 1, 2019
Accepted: December 7, 2019
Article in press: December 7, 2019
Published online: December 14, 2019
Processing time: 44 Days and 18.6 Hours
Abstract
BACKGROUND

Increasing levels of antibiotic resistance have reduced the Helicobacter pylori (H. pylori) eradication rates afforded by the standard triple therapy. Thus, 2-wk first-line four-drug regimens must be considered.

AIM

To analyze the eradication rates of modified bismuth-containing quadruple therapy (mBCQT) and concomitant therapy (CT), the associated adverse events, and compliance.

METHODS

Patients infected with H. pylori were prospectively randomized to receive mBCQT or CT for 2 wk. mBCQT featured a proton pump inhibitor (PPI), bismuth, metronidazole, and tetracycline, taken twice daily. CT included a PPI, clarithromycin, metronidazole, and amoxicillin, taken twice daily. The 13C-urea breath test was performed no earlier than 4 wk after therapy concluded to confirm eradication. If either the histological or rapid urease test was positive, H. pylori infection was diagnosed.

RESULTS

The demographic characteristics of 68 patients who received mBCQT and 68 who received CT did not differ significantly. On intention-to-treat analysis, the eradication rate was 88.2% (60/68) in the mBCQT group and 79.4% (54/68) in the CT group (P = 0.162). By per-protocol analysis, the respective eradication rates were 98.4% (60/61) and 93.1% (54/58) (P = 0.199). More CT than mBCQT patients experienced adverse events [33.8% (23/68) mBCQT vs 51.5% (35/58) CT patients, respectively, P = 0.037]. All patients showed good compliance [85.3% (58/68) mBCQT vs 82.4% (56/68) CT patients, P = 0.641].

CONCLUSION

The H. pylori eradication rates of the 2-wk mBCQT and CT regimens are high. Most patients show good compliance, and more CT than mBCQT patients experience adverse events.

Keywords: Helicobacter pylori; Therapy; Bismuth-containing quadruple therapy; Concomitant therapy

Core tip: Both modified bismuth-containing quadruple therapy and concomitant therapy proved to be useful empirical first-line treatment options for Helicobacter pylori eradication in an area exhibiting high-level clarithromycin resistance (> 15%).