Clinical Trials Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 7, 2019; 25(17): 2110-2121
Published online May 7, 2019. doi: 10.3748/wjg.v25.i17.2110
Beneficial effect of probiotics supplements in reflux esophagitis treated with esomeprazole: A randomized controlled trial
Qing-Hua Sun, Hong-Yan Wang, Shi-Dong Sun, Xin Zhang, Han Zhang
Qing-Hua Sun, Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
Hong-Yan Wang, Shi-Dong Sun, Xin Zhang, Han Zhang, Department of Gastroenterology, PKUCare Luzhong Hospital, Zibo 255400, Shandong Province, China
Author contributions: Sun SD designed the research; Wang HY, Zhang X, and Zhang H performed the research; Sun SD and Wang HY contributed new reagents and analytic tools; Wang HY analyzed the data; Sun QH wrote the paper.
Supported by Shandong Provincial Medical and Health Technology Development Project, No. 2014ws0020.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of PKUCare Luzhong Hospital [2015-KY-003].
Clinical trial registration statement: This study is registered on the Chinese Clinical Trial Registry (No. ChiCTR1800018218).
Informed consent statement: All study participants, or their legal guardian, provided written informed consent prior to study enrollment.
Conflict-of-interest statement: The authors declare that they have no competing interests.
Data sharing statement: No additional data.
CONSORT 2010 statement: CONSORT 2010 checklist of information to include when reporting a randomized trial has been completed.
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/
Corresponding author: Shi-Dong Sun, Director, Vice President of Hospital, Department of Gastroenterology, PKUCare Luzhong Hospital, No. 65, Taigong Road, Linzi District, Zibo 255400, Shandong Province, China. sunshidong@163.com
Telephone: +86-533-7698006 Fax: +86-533-7698019
Received: January 11, 2019
Peer-review started: January 11, 2019
First decision: January 30, 2019
Revised: February 15, 2019
Accepted: February 22, 2019
Article in press: February 23, 2019
Published online: May 7, 2019
Processing time: 115 Days and 23.4 Hours
Abstract
BACKGROUND

Reflux esophagitis (RE) is a common digestive disorder, and its frequent recurrences cause significant physical pain and are financially burdensome to patients. However, studies on the natural history of treated RE are few. Although proton pump inhibitors (PPIs) as the first-line treatment provide notable symptomatic relief, disordered gut microbiota has been observed among PPI users. Probiotics are commonly administered to patients to regulate the disordered intestinal flora.

AIM

To evaluate the therapeutic effects in RE patients treated with a combination of esomeprazole and probiotics [Bacillus subtilis (B. subtilis) and Enterococcus faecium (E. faecium)].

METHODS

One hundred and thirty-four RE patients were randomized into two groups of 67 subjects each. The probiotics group was administered with esomeprazole 20 mg b.i.d. and live combined B. subtilis and E. faecium enteric-coated capsules 500 mg t.i.d. for eight weeks; the placebo group was administered with esomeprazole 20 mg b.i.d. and placebo for eight weeks. Subsequently, 12-wk follow-up was carried out on patients who achieved both endoscopic and clinical cure. Endoscopy, reflux diagnostic questionnaire (RDQ), gastrointestinal symptom rating scale (GSRS), and lactulose hydrogen breath test were performed to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.

RESULTS

Sixty-six patients in the probiotics group and 64 patients in the placebo group completed the 8-wk treatment. The healing rate and RDQ score had no significant difference between the two groups (P > 0.05). However, the GSRS diarrhea syndrome score was decreased significantly in the probiotics group (P = 0.002), and the small intestinal bacterial overgrowth negative rate in the probiotics group was significantly higher than that in the placebo group (P = 0.002). Of 114 endoscopically and clinically cured patients, 96 completed the follow-up. The log-rank test showed that the time to relapse was shorter in the placebo group than in the probiotics group (P = 0.041). Furthermore, the therapy had a significant influence on relapse time, and the risk of relapse in the probiotics group was lower than that in the placebo group at any time point during the 12-wk follow-up (hazard ratio = 0.52, P = 0.033).

CONCLUSION

Esomeprazole combined with probiotics (B. subtilis and E. faecium) have a beneficial effect on RE treatment and patient management.

Keywords: Proton pump inhibitors; Probiotics; Small intestinal bacterial overgrowth; Reflux esophagitis; Relapse

Core tip: Reflux esophagitis (RE) recurrences cause significant physical pain and financial burden to patients. Proton pump inhibitors (PPIs) are the first-line treatment for RE. Although PPIs provide notable symptomatic relief, their effects on the gut microbiota have drawn attention. In the present study, we evaluated the effectiveness of combining esomeprazole with probiotics [Bacillus subtilis (B. subtilis) and Enterococcus faecium (E. faecium)]. We found that the combined administration could reduce the incidence of small intestinal bacterial overgrowth and improve abdominal symptoms in patients with RE. It may also prolong the time to relapse, showing the potential of probiotics (B. subtilis and E. faecium) for the treatment and management of RE.