Bowel preparation efficacy and discomfort of 2 L polyethylene glycol combined with linaclotide versus 3 L polyethylene glycol: a noninferiority, prospective, multicenter, randomized controlled trial

Jiandi Wu; Song Liu; Shuyu Li; Gangping Li; Erchuan Wang; Tao Bai; Xiaohua Hou; Jun Song

doi:10.1177/17562848241299739

Bowel preparation efficacy and discomfort of 2 L polyethylene glycol combined with linaclotide versus 3 L polyethylene glycol: a noninferiority, prospective, multicenter, randomized controlled trial

Therap Adv Gastroenterol. 2024 Nov 19:17:17562848241299739. doi: 10.1177/17562848241299739. eCollection 2024.

Authors

Jiandi Wu¹, Song Liu², Shuyu Li³, Gangping Li¹, Erchuan Wang¹, Tao Bai¹, Xiaohua Hou⁴, Jun Song⁴

Affiliations

¹ Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
² Department of Gastroenterology, Wuhan No. 1 Hospital, Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, Hubei, China.
³ Department of Gastroenterology, Hubei No. 3 People's Hospital of Jianghan University, Wuhan, China.
⁴ Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Road, Wuhan 430022, China.

Abstract

Background: Three liters of polyethylene glycol administered in a split dose is a commonly recommended regimen for bowel preparation before colonoscopy.

Objectives: The aim of this study was to compare the quality and tolerability of low-dose (2 L) polyethylene glycol combined with linaclotide (2 L+L) versus the 3 L polyethylene glycol (PEG) bowel preparation regimen.

Design: A noninferiority, prospective, multicenter, randomized controlled trial.

Methods: In this noninferiority, prospective, multicenter, randomized controlled study, patients scheduled for colonoscopy were enrolled and randomized to receive a 3 L PEG or 2L PEG+L regimen. The quality of bowel preparation and patients' discomfort was assessed.

Results: Over 12 months, 458 patients were randomized into 3 L PEG and 2 L+L groups. The primary endpoints showed that the 2 L+L regimen was superior to the 3L PEG regimen in overall bowel cleansing scores (Ottawa Bowel Preparation Scale: 3.3 ± 2.1 vs 3.7 ± 2.1, p = 0.021), but no significant difference in adequate bowel preparation rate between the two groups according to the OBPS score (97% vs 97.4%, p = 0.791). Before colonoscopy, patients in the 2 L +L regimen group had lower bloating scores (0.5 (0, 2) vs 1 (0, 3), p = 0.013), discomfort scores (1 (0, 2) vs 1 (0, 3), p = 0.006), and intolerability scores (1 (0, 3) vs 2 (0, 4), p = 0.016) than did those in the 3L PEG group.

Conclusion: Two liters of polyethylene glycol combined with linaclotide may be an alternative regimen to 3 L of PEG taken in split doses for bowel preparation before colonoscopy.

Trial registration: ChiCTR2100041992.

Keywords: bowel preparation; colonoscopy; linaclotide; polyethylene glycol.

Plain language summary

Improvement in bowel preparation efficacy and patients’ discomfort after polyethylene glycol (2 L) combined with linaclotide. The commonly recommended intestinal cleanser regimen is 3 L of polyethylene glycol, which achieves cleansing of the intestinal segments but may give discomfort to the patients. We have conducted a noninferiority, prospective, multicenter, randomized controlled trial to compare 2 L polyethylene glycol+ linaclotide and 3 L polyethylene glycol. The results showed that similar patients’ percentage had adequate bowel preparation rate in two groups according to the OBPS score. However, the 2 L+L regimen was superior to the 3 L PEG regimen in overall bowel cleansing scores and patients’ discomfort. Trial registration number: ChiCTR2100041992.