Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial.

Abstract

Several studies have investigated the role of linaclotide in bowel preparation; however, dosage and timing still warrant further exploration. This noninferiority randomized controlled study was performed in 16 medical centers. The eligible subjects were randomly assigned to 3 groups: the Lct + 3 L polyethylene glycol (PEG) group (group A), the 3 L PEG group (group B), or the Lct + 2 L PEG group (group C). The primary outcome was the adequate bowel preparation rate based on the Boston Bowel Preparation Scale. Safety was assessed based on the incidence of adverse reactions. A total of 1,607 eligible subjects were enrolled, and 1,545 colonoscopy videos were uploaded. In the intention-to-treat analysis, the results of the noninferiority test indicated that the adequate bowel preparation rate in group C (87.58%, 95% confidence interval [CI] 85.08%-90.62%) was neither inferior to that of group A (88.79%, 95% CI 86.11%-91.46%) nor group B (83.99%, 95% CI 80.88%-87.09%). The overall incidence of adverse reactions in group A was higher than that in group C (13.64% vs 8.19%, P = 0.012). There were no significant differences in polyp detection rate ( P = 0.089), adenoma detection rate ( P = 0.776), and bowel preparation completion rate ( P = 0.052). The adequate bowel preparation rate of the combination of 3-day linaclotide and 2 L PEG was neither inferior to the combination of 3-day linaclotide and 3 L PEG nor 3 L PEG alone in the average-risk population.