Randomized Controlled Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 7, 2015; 21(1): 351-359
Published online Jan 7, 2015. doi: 10.3748/wjg.v21.i1.351
Concomitant therapy achieved the best eradication rate for Helicobacter pylori among various treatment strategies
Hyun Jeong Lee, Jin Il Kim, Jin Soo Lee, Eun Jung Jun, Jung-Hwan Oh, Dae Young Cheung, Woo Chul Chung, Byung-Wook Kim, Sung Soo Kim
Hyun Jeong Lee, Jin Il Kim, Jin Soo Lee, Eun Jung Jun, Jung-Hwan Oh, Dae Young Cheung, Woo Chul Chung, Byung-Wook Kim, Sung Soo Kim, Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul 150-713, South Korea
Author contributions: Lee HJ wrote the manuscript; Lee HJ and Kim JI concept and designed this study; Kim JI, Lee JS, Jun EJ, Oh JH, Cheung DY, Chung WC, Kim BW, Kim SS collected the data.
Supported by Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, Science and Technology, No. 2013R1A1A2062603
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/
Correspondence to: Jin Il Kim, MD, PhD, Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, 62 Yeouido-dong, Yeongdeungpo-gu, Seoul 150-713, South Korea. jikim@catholic.ac.kr
Telephone: +82-2-37791519 Fax: +82-2-37791331
Received: April 30, 2014
Peer-review started: April 30, 2014
First decision: May 29, 2014
Revised: July 8, 2014
Accepted: July 24, 2014
Article in press: July 25, 2014
Published online: January 7, 2015
Processing time: 251 Days and 22.3 Hours
Abstract

AIM: To compare the Helicobacter pylori (H. pylori) eradication rate of clarithromycin-based triple therapy, metronidazole-based triple therapy, sequential therapy and concomitant therapy.

METHODS: A total of 680 patients infected with H. pylori were divided into 4 groups and each group was treated with a different eradication therapy. Clarithromycin-based triple therapy was applied to the first group [rabeprazole, amoxicillin and clarithromycin (PAC) group: proton pump inhibitor (PPI), amoxicillin, clarithromycin], whereas the second group was treated with metronidazole-based triple therapy [rabeprazole, amoxicillin and metronidazole (PAM) group: PPI, amoxicillin, metronidazole]. The third group was treated with rabeprazole and amoxicillin, followed by rabeprazole, clarithromycin and metronidazole (sequential group). The final group was simultaneously treated with rabeprazole, amoxicillin clarithromycin and metronidazole (concomitant therapy group). In the case of a failure to eradicate H. pylori, second-line quadruple and third-line eradication therapies were administered.

RESULTS: The per protocol (PP) analysis was performed on 143, 139, 141 and 143 patients in the PAC, PAM, sequential and concomitant groups, respectively. We excluded patients who did not receive a C13-urea breath test (22, 20, 23 and 22 patients, respectively) and patients with less than an 80% compliance level (5, 11, 6 and 5 patients, respectively). The eradication rates were 76.2% (109/143) in the PAC group, 84.2% (117/139) in the PAM group, 84.4% (119/141) in the sequential group and 94.4% (135/143) in the concomitant group (P = 0.0002). All 14 patients who failed second-line therapy were treated with third-line eradication therapy. Among these 14 patients, 6 infections were successfully eradicated with the third-line therapy. Both PP and intention-to-treat analysis showed an eradication rate of 42.9% (6/14). In the PAC group, 3 of 4 patients were successfully cured (3/4, 75%); 2 of 2 patients in the PAM group (2/2, 100%) and 1 of 5 patients in the sequential group (1/5, 20%) were also cured. In the concomitant group, all 3 patients failed (0/3, 0%).

CONCLUSION: The eradication rate for the concomitant therapy was much higher than those of the standard triple therapy or sequential therapy (ClinicalTrials.gov number NCT01922765).

Keywords: Helicobacter pylori; Eradication; Drug resistance; Concomitant therapy; Sequential therapy

Core tip: A total 680 patients who were infected with Helicobacter pylori (H. pylori) were divided into 4 groups and each group was treated with a different eradication therapy. The eradication rates were 76.2%, 84.2%, 84.4% and 94.4% in the rabeprazole, amoxicillin and clarithromycin (PAC) group, the rabeprazole, amoxicillin and metronidazole group, the sequential group and the concomitant group. Comparing concomitant therapy and PAC therapy, the number needed to treat was 5.49. The eradication rate was 84.4% for the second-line therapy and 42.9% for the third-line therapy. The study was designed due to the high prevalence of H. pylori and gastric cancer and the recent marked increase in clarithromycin resistance.