Clinical Trials Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 21, 2015; 21(39): 11179-11184
Published online Oct 21, 2015. doi: 10.3748/wjg.v21.i39.11179
Effects of daily telephone-based re-education before taking medicine on Helicobacter pylori eradication: A prospective single-center study from China
Chun-Hua Wang, Sheng-Tao Liao, Jun Yang, Chun-Xia Li, Ying-Ying Yang, Ran Han, Dong-Feng Chen, Chun-Hui Lan
Chun-Hua Wang, Jun Yang, Chun-Xia Li, Ying-Ying Yang, Dong-Feng Chen, Chun-Hui Lan, Department of Gastroenterology, Daping Hospital, the Third Military Medical University, Chongqing 400042, China
Sheng-Tao Liao, Cadet Brigade, the Third Military Medical University, Chongqing 400042, China
Ran Han, Department of Gastroenterology, Guizhou Aerospace Hospital, Zunyi 563000, Guizhou Province, China
Author contributions: Lan CH designed the research; Wang CH, Yang J, Li CX and Yang YY performed the research; Han R and Chen DF contributed new reagents or analytic tools; Wang CH and Liao ST analyzed the data; Liao ST and Lan CH wrote the paper.
Supported by National Natural Science Foundation of China, No. 81171526 and No. 81472006.
Institutional review board statement: The study was reviewed and approved by Daping Hospital, Third Military Medical University Institutional Review Board.
Clinical trial registration statement: This study is registered at http://www.chictr.org.cn/showproj.aspx?proj=4382. The registration identification number is ChiCTR-TRC-14005193.
Informed consent statement: All study participants or their legal guardian provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Chun-Hua Wang, Sheng-Tao Liao, Jun Yang, Chun-Xia Li, Ying-Ying Yang, Ran Han, Dong-Feng Chen, and Chun-Hui Lan have no conflicts of interest or financial ties to disclose.
Data sharing statement: No additional data are available.
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: Chun-Hui Lan, MD, Department of Gastroenterology, Daping Hospital, the Third Military Medical University, No. 10 Changjiang Branch Road, Chongqing 400042, China. tiandaochouqin99@hotmail.com
Telephone: +86-23-68757616 Fax: +86-23-68757616
Received: March 5, 2015
Peer-review started: March 12, 2015
First decision: April 24, 2015
Revised: May 15, 2015
Accepted: August 29, 2015
Article in press: August 29, 2015
Published online: October 21, 2015
Processing time: 227 Days and 17.3 Hours
Abstract

AIM: To investigate the effects of daily telephone-based re-education (TRE) before taking medicine for the eradication of Helicobacter pylori (H. pylori) on the compliance and the eradication rate in a Chinese patient population.

METHODS: A prospective, physician-blinded, randomized, controlled clinical study was conducted. The patients were randomly assigned to receive TRE every day before taking medicine (TRE group) or no TRE (control group). The patients in the TRE group received regular instructions before taking medicine for the eradication of H. pylori during the entire course of treatment through telephone calls. The patients in the control group received detailed instructions at the time of seeing a doctor for the guidance. The primary outcome was the H. pylori eradication rate after treatment. The secondary outcomes included the clinical remissions after treatment, adverse events, compliance, and patients’ satisfaction.

RESULTS: A total of 140 patients were randomized, 70 to the TRE group and 70 to the control group. As the primary outcome, the H. pylori eradication rates in the TRE and control groups were 62.7% and 71.2% in per protocol analysis (P = 0.230), and 52.9% and 52.9% in intention-to-treat analysis (P = 0.567), respectively. As the secondary outcomes, there were no significant differences in the patients’ satisfaction between the two groups (good, 79.7% vs 76.9%; fair, 13.6% vs 19.2%; poor, 6.7% vs 3.9%, for the TRE group and control group, respectively; P > 0.05 for all); the rates of adverse effects were 15.2% and 63.5% in the TRE and control groups, respectively (P < 0.001); the compliance rates in the TRE and control groups were 85.7% and 74.3%, respectively (P = 0.069).

CONCLUSION: Daily TRE before taking medicine had no significant impact on the patients’ compliance, satisfaction, or H. pylori eradication, but reduced the rate of adverse events.

Keywords: Helicobacter pylori; Eradication; Telephone re-education; Compliance; Adverse events

Core tip: Compliance is an important factor affecting Helicobacter pylori (H. pylori) eradication. The present study is the first attempt to evaluate the telephone re-education (TRE) in H. pylori treatment in China. The daily TRE neither improved the eradication rate nor the patients’ compliance or satisfaction, but decreased adverse effects. Meanwhile, adverse effects may not be the main reason for poor compliance. Our results suggest that compliance is not the important reason for a decreased H. pylori eradication rate in China.