Polyethylene Glycol Maintenance Treatment for Childhood Functional Constipation: A Randomized, Placebo-controlled Trial

Objective: The aim of this study was to investigate the long-term efficacy of polyethylene glycol (PEG) during maintenance treatment of childhood functional constipation (FC) in a randomized, double-blinded, placebo-controlled trial. Methods: Children (2–16 years) with FC according to the Rome III criteria were randomly assigned to maintenance treatment with PEG or placebo for 24 weeks. Children reporting treatment failure before 24 weeks were switched to conventional treatment. Primary outcome was successful treatment, defined as absence of any Rome III criteria with or without use of medication after 24 weeks. Results: A total of 102 children were included: PEG/placebo: 49/53. At 24 weeks, significantly more patients in the PEG group, compared to the placebo group, were successfully treated (33 [67%] vs 19 [36%] hazard ratio (95% confidence intervals) = 3.21 [1.73–5.94]). Significantly fewer children in the PEG group switched to rescue medication (2 [4%] vs 30 [57%], P 

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