Randomized Controlled Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 28, 2015; 21(16): 5023-5031
Published online Apr 28, 2015. doi: 10.3748/wjg.v21.i16.5023
Irsogladine maleate and rabeprazole in non-erosive reflux disease: A double-blind, placebo-controlled study
Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine
Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan
Author contributions: Suzuki T and Matsushima M designed the research; Suzuki T and Masui A analyzed the data; Suzuki T, Matsushima M, Tsuda S, Imai J, Nakamura J, Tsukune Y, Uchida T, Yuhara H, Igarashi M, Koike J and Mine T performed the research; and Suzuki T wrote the paper.
Ethics approval: The study was reviewed and approved by the Tokai University’s Ethics Committee. This study was performed in accordance with the principles laid down in the Declaration of Helsinki.
Clinical trial registration: This study was registered in the UMIN Clinical Trials Registry. The registration identification number is UMIN000015731.
Informed consent: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest: The authors have no conflicts of interest to declare.
Data sharing: All of the participants gave their informed consent for data sharing.
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: Dr. Takayoshi Suzuki, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan. takayosh@is.icc.u-tokai.ac.jp
Telephone: +81-463-931121 Fax: +81-463-937134
Received: October 18, 2014
Peer-review started: October 21, 2014
First decision: November 14, 2014
Revised: December 9, 2014
Accepted: February 12, 2015
Article in press: February 13, 2015
Published online: April 28, 2015
Processing time: 191 Days and 2.7 Hours
Abstract

AIM: To evaluate the efficacy of adding irsogladine maleate (IM) to proton-pump inhibitor (PPI) therapy in non-erosive reflux disease (NERD) treatment.

METHODS: One hundred patients with NERD were recruited and randomized to receive rabeprazole plus IM (group I) or rabeprazole plus placebo (group P). The efficacy of the treatment was assessed using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG) and the short form (SF)-36 quality of life questionnaires after four weeks of treatment. We also assessed whether patients with NERD with minimal changes (grade M) had different responses to the therapies compared with patients who did not have minimal changes (grade N).

RESULTS: Group I and group P showed significant improvements in their FSSG scores after the treatment (from 17.9 ± 7.9 to 9.0 ± 7.6, and from 17.7 ± 7.3 to 11.2 ± 7.9, respectively, P = 0.0001), but there was no statistically significant difference between the FSSG scores in group I and those in group P. Subgroup analysis showed that significant improvements in the FSSG scores occurred in the patients in group I who had NERD grade N (modified Los Angeles classification) (7.8 ± 7.4 vs 12.5 ± 9.8, P = 0.041). The SF-36 scores for patients with NERD grade N who had received IM and rabeprazole were significantly improved in relation to their vitality and mental health scores.

CONCLUSION: The addition of IM to rabeprazole significantly improves gastroesophageal reflux disease symptoms and the quality of the lives of patients with NERD grade N.

Keywords: Irsogladine maleate; Rabeprazole; Non-erosive reflux disease; Randomized controlled trial; Frequency scale for the symptoms of gastroesophageal reflux disease; Quality of life

Core tip: Proton pump inhibitor (PPI) therapy is considered the mainstay for the treatment of non-erosive reflux disease (NERD). However, it is less effective in NERD than it is in reflux esophagitis. This study evaluated the efficacy of adding irsogladine maleate (IM) to PPI therapy in the treatment of NERD. Adding IM to rabeprazole improved both the gastroesophageal reflux disease symptoms and the quality of the lives of patients with NERD showing no endoscopic abnormalities, a categorization that was based on the modified Los Angeles classification.