Kim SJ, Chung JW, Woo HS, Kim SY, Kim JH, Kim YJ, Kim KO, Kwon KA, Park DK. Two-week bismuth-containing quadruple therapy and concomitant therapy are effective first-line treatments for Helicobacter pylori eradication: A prospective open-label randomized trial. World J Gastroenterol 2019; 25(46): 6790-6798 [PMID: 31857780 DOI: 10.3748/wjg.v25.i46.6790]
Corresponding Author of This Article
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
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Gastroenterology & Hepatology
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Randomized Controlled Trial
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Kim SJ, Chung JW, Woo HS, Kim SY, Kim JH, Kim YJ, Kim KO, Kwon KA, Park DK. Two-week bismuth-containing quadruple therapy and concomitant therapy are effective first-line treatments for Helicobacter pylori eradication: A prospective open-label randomized trial. World J Gastroenterol 2019; 25(46): 6790-6798 [PMID: 31857780 DOI: 10.3748/wjg.v25.i46.6790]
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.
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.
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%).
