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

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.