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©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean®) with a polyethylene glycol/bisacodyl kit
Shih-Ya Hung, Hung-Chang Chen, Tao-Wei Ke, Jiann-Hwa Chen, Koung-Hung Hsiao, Hwei-Ming Wang, Hua-Che Chiang, Sheng-Chi Chang, Yi-Chang Chen, Ming-Hao Hsieh, Yuan-Yao Tsai, Yo-Wen Hsieh, William Tzu-Liang Chen
Shih-Ya Hung, Graduate Institute of Acupuncture Science, China Medical University, Taichung 40402, Taiwan
Shih-Ya Hung, Department of Medical Research, China Medical University Hospital, Taichung 40447, Taiwan
Hung-Chang Chen, Tao-Wei Ke, Hwei-Ming Wang, Hua-Che Chiang, Sheng-Chi Chang, Yi-Chang Chen, Ming-Hao Hsieh, Yuan-Yao Tsai, Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan
Jiann-Hwa Chen, Division of Gastroenterology, Taipei Tzu Chi Hospital, Taipei 23142, Taiwan
Koung-Hung Hsiao, Division of Colorectal Surgery, Taipei Tzu Chi Hospital, Taipei 23142, Taiwan
Yo-Wen Hsieh, Department of Pharmacy, China Medical University Hospital, Taichung 40447, Taiwan
William Tzu-Liang Chen, Department of Colorectal Surgery, China Medical University Hsinchu Hospital, Zhubei 30272, Taiwan
William Tzu-Liang Chen, School of Medicine, China Medical University, Taichung 40402, Taiwan
Author contributions: Chen WTL and Chen HC worked on conceptualization, methodology, and project administration; Chen WTL and Hung SY worked on original draft preparation and manuscript editing; Chen HC, Ke TW, Chen JH, Hsiao KH, Wang HM, Chiang HC, Chang SC, Chen YC, Hsieh MH, Tsai YY, and Chen WTL performed colonoscopy, data collection, and data curation; Hsieh YW worked on drug dispensing and pharmaceutical care.
Supported by The China Medical University Hospital, No. DMR-108-125.
Institutional review board statement: This study was reviewed and approved by the Institutional Review Boards of China Medical University Hospital (CMUH107-REC2-151) and Taipei Tzu Chi Hospital (08-FS-030). Study methods were conducted in accordance with the Institutional Review Board committee guidelines.
Clinical trial registration statement: This study has been registered at https://clinicaltrials.gov/ct2/show/NCT03992365 (ID: NCT03992365).
Informed consent statement: Written informed consent was provided by all study participants.
Conflict-of-interest statement: Quiklean® was provided by Universal Integrated Corporation (Taiwan). The authors have no conflicts of interest to declare.
Data sharing statement: No additional data are available.
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: William Tzu-Liang Chen, MD, Superintendent, Department of Colorectal Surgery, China Medical University Hsinchu Hospital, No. 199 Sec. 1, Xinglong Road, Zhubei 30272, Taiwan. wtchen@mail.cmuh.org.tw
Received: November 5, 2020
Peer-review started: November 5, 2020
First decision: December 13, 2020
Revised: December 24, 2020
Accepted: January 6, 2021
Article in press: January 6, 2021
Published online: February 7, 2021
BACKGROUND
Efficient bowel cleansing is essential for a successful colonoscopy, but the ideal cleansing agent, volume, and pharmaceutical dosage form have yet to be determined. Small-volume cleansers enhance patient compliance.
AIM
To compare the bowel cleansing efficacy of 32-tablet sodium phosphate (Quiklean®) with 2-L polyethylene glycol (PEG)/bisacodyl (Klean-Prep/ Dulcolax®) under identical dietary recommendations.
METHODS
This multicenter, randomized, parallel-group, noninferiority clinical trial enrolled 472 outpatients, randomized 456 subjects, and scheduled 442 subjects to undergo colonoscopy (Quiklean® = 222 and Klean-Prep/Dulcolax® = 220). After bowel preparation, a colonoscopist performed the colonoscopy with video recorded for rating. The primary efficacy endpoint was the bowel cleansing quality using the Aronchick Scale. The secondary endpoints were the bowel cleansing efficacy of three colon segments, tolerability and acceptability, safety using the Ottawa bowel preparation scale, questionnaires by subjects, and monitoring of adverse events.
RESULTS
Success rates (Excellent + Good) of the bowel cleansing quality by Aronchick Scale were 98.6% (n = 205) and 97.6% (n = 204) in the Quiklean® and Klean-Prep/Dulcolax® groups, respectively. Quiklean® demonstrated noninferiority over Klean-Prep/Dulcolax® in colon cleansing efficacy. Quicken showed better tolerability and acceptability in the overall experience (was rated as excellent; 24.0% vs 17.2%; P = 0.0016) and the taste of the study preparation (was rated as excellent, 23.1% vs 13.4%; P < 0.0001) than Klean-Prep/Dulcolax®. Safety profiles did not differ between the two groups. Our data indicate that Quiklean® is an adequate, well-tolerated bowel cleansing preparation compared with the standard comparator Klean-Prep/Dulcolax®.
CONCLUSION
Quiklean® is sodium phosphate tablets available on Taiwan’s market for bowel preparation; it potentially offers patients an alternative to standard large-volume bowel preparation regimens and may, therefore, increase positive attitudes toward colonoscopies and participation rates.
Core Tip: The bowel cleanser 32-tablet sodium phosphate (Quiklean®) is an adequate bowel cleansing preparation with better tolerability and acceptability than the standard comparator 2-L polyethylene glycol/bisacodyl (Klean-Prep/Dulcolax®).
