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

Abstract

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 < 0.001). Time before the change to rescue medication was 13 and 27 days, respectively, for each of the 2 children in the PEG group who required rescue medication. Median time to shift to rescue medication was 27 days (range: 3-64 days) in the placebo group. At 24 weeks after initiation of treatment, 33 children (67%) in the PEG group were successfully treated, compared to 19 children (32%) in the placebo group (hazard ratio (95% confidence intervals) = 3.21 [1.73-5.94]). No serious adverse event related to use of the medication was registered.

Conclusions: Maintenance treatment with PEG is significantly more effective than placebo in preventing relapse of constipation symptoms during long-term maintenance treatment in childhood FC. We therefore recommend that maintenance treatment commence after disimpaction.