Randomized Controlled Trial
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Feb 26, 2019; 7(4): 452-465
Published online Feb 26, 2019. doi: 10.12998/wjcc.v7.i4.452
Efficacy of 1.2 L polyethylene glycol plus ascorbic acid for bowel preparations
Hiroyuki Tamaki, Teruyo Noda, Masahiro Morita, Akina Omura, Atsushi Kubo, Chikara Ogawa, Toshihiro Matsunaka, Mitsushige Shibatoge
Hiroyuki Tamaki, Teruyo Noda, Masahiro Morita, Akina Omura, Atsushi Kubo, Chikara Ogawa, Toshihiro Matsunaka, Mitsushige Shibatoge, Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Kagawa 760-0017, Japan
Author contributions: Tamaki H was fully involved in the patient management, acquisition and interpretation of data, statistics, drafting, and preparation of final manuscript version; Shibatoge M was contributed to make the conception, study design, interpretation of data and critical review of the final manuscript version; all authors contributed to correction of the clinical data.
Institutional review board statement: The protocol of this study was approved by the Investigational Review Board of Takamatsu Red Cross Hospital.
Clinical trial registration: This trial is registered at https://www.umin.ac.jp/ctr/index-j.htm. The registration identification number is UMIN000020904.
Informed consent statement: All patients provided written informed consent for their participation.
Conflict-of-interest statement: The authors of this manuscript have no conflicts of interest to disclose.
Data sharing statement: All authors agree that if this manuscript is finally accepted for publication, the Copyright License Agreement will become effective immediately.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
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: Mitsushige Shibatoge, MD, PhD, Department of Gastroenterology, Takamatsu Red Cross Hospital, 4-1-3 Ban-cho, Takamatsu, Kagawa 760-0017 Japan. shibatoge-mitsusige@takamatsu.jrc.or.jp
Telephone: +81-87-8317101 Fax: +81-87-8347809
Received: October 25, 2018
Peer-review started: October 26, 2018
First decision: November 29, 2018
Revised: December 24, 2018
Accepted: January 23, 2019
Article in press: January 24, 2019
Published online: February 26, 2019
Processing time: 124 Days and 10.1 Hours
Abstract
BACKGROUND

A low-volume polyethylene glycol (PEG) solution that combines ascorbic acid with PEG-based electrolyte solution (PEG-ASC) is gaining mainstream acceptance for bowel preparation due to reduced volume and improved taste. Although several reports showed that bowel preparation with PEG-ASC volume lower than 2.0 L with laxative agents could be an alternative to traditional preparation regimen, the cleansing protocols have not been fully investigated.

AIM

To evaluate the cleansing efficacy of 1.2 L PEG-ASC solution comparing with 2.0 L PEG electrolyte (PEG-ELS) for bowel preparations.

METHODS

A randomized, single-blinded, open-label, single-center, non-inferiority study was conducted. In total, 312 Japanese adult patients (aged > 18 years) who underwent colonoscopy were enrolled. Patients were randomly allocated to bowel lavage with either 1.2 L of PEG-ASC solution with at least 0.6 L of an additional clear fluid (1.2 L PEG-ASC group) or 2.0 L of PEG-ELS (PEG-ELS group). Then, 48 mg of sennoside was administered at bedtime on the day before colonoscopy, and the designated drug solution was administered at the hospital on the day of colonoscopy. Bowel cleansing was evaluated using the Boston Bowel Preparation Scale (BBPS). The volume of fluid intake and required time for bowel preparation were evaluated. Furthermore, compliance, patient tolerance, and overall acceptability were evaluated using a patient questionnaire, which was assessed using a visual analog scale.

RESULTS

In total, 291 patients (1.2 L PEG-ASC group, 148; PEG-ELS group, 143) completed the study. There was no significant difference in successful cleansing, defined as a BBPS score ≥ 2 in each segment, between the two groups (1.2 L PEG-ASC group, 91.9%; PEG-ELS group, 90.2%; 95%CI: -0.03-0.09). The required time for bowel preparation was significantly shorter (164.95 min ± 68.95 min vs 202.16 min ± 68.69 min, P < 0.001) and the total fluid intake volume was significantly lower (2.23 L ± 0.55 L vs 2.47 L ± 0.56 L, P < 0.001) in the 1.2 L PEG-ASC group than in the PEG-ELS group. Palatability, acceptability of the volume of solution, and overall acceptability evaluated using a patient questionnaire, which was assessed by the visual analog scale, were significantly better in the 1.2 L PEG-ASC group than in the PEG-ELS group (7.70 cm ± 2.57 cm vs 5.80 cm ± 3.24 cm, P < 0.001). No severe adverse event was observed in each group.

CONCLUSION

The 1.2 L PEG-ASC solution was non-inferior to the 2.0 L PEG-ELS solution in terms of cleansing efficacy and had better acceptability among Japanese patients.

Keywords: Ascorbic acid; Bowel preparation; Colonoscopy; Efficacy; Polyethylene glycol; Tolerability

Core tip: Adequate bowel preparation is essential to improve colonoscopy quality. Volume and palatability of bowel cleansing agents are important determinants of tolerability, acceptability, and efficacy. This randomized study evaluated the non-inferiority of 1.2 L polyethylene glycol plus ascorbic acid (PEG-ASC) plus sennoside to 2.0 L PEG electrolyte (PEG-ELS) solutions plus sennoside for outpatient bowel preparation. The 1.2 L PEG-ASC and 2.0 L PEG-ELS solutions are clinically equivalent with respect to cleansing efficacy. Furthermore, the 1.2 L PEG-ASC solution was superior to 2.0 L PEG-ELS solution in terms of acceptability, and it was associated with a shorter required time for bowel preparation and a lower volume of fluid intake.