Randomised clinical trial: macrogol/PEG 3350+electrolytes versus prucalopride in the treatment of chronic constipation - a comparison in a controlled environment

Background Constipation is a common condition for which PEG 3350 is an established treatment and prucalopride has recently been approved for this indication. Aim To compare the efficacy, safety and impact on quality of life (QoL) of PEG 3350 plus electrolytes (PEG 3350+E) vs. prucalopride in females with chronic constipation (CC) in whom laxatives have previously failed to provide adequate relief. Methods In this single-centre, randomised, double-blind, double-dummy study, patients with CC [<3 spontaneous complete bowel movements (SCBM)/week] remained in a controlled environment and received either a 26g split dose of PEG 3350+E (N=120) or 12mg prucalopride (N=120) daily for 28days following a 14-day run-in period. The primary endpoint was the proportion of patients having 3 SCBMs during the last treatment week. Results Non-inferiority of PEG 3350+E to prucalopride was demonstrated in the per-protocol population [difference, 10.1% (66.67% vs. 56.52%), 97.5% lower confidence interval (CI) 2.7%, above the preset margin of 20%] and approached superiority in the modified intent-to-treat population (difference, 9.8%, 97.5% lower CI, 3.1%). Statistically significant differences in favour of PEG 3350+E were observed for most secondary variables (bowel movements, stool weight, consistency, time to next SCBM, patient perception of straining and completeness of defecation). Colonic transit time was dramatically reduced in both arms. Both treatments were well tolerated. Conclusion PEG 3350+E was at least as effective as and generally better tolerated than prucalopride as a treatment for chronic constipation in this study population (NCT01251822; http://www.clinicaltrials.gov).