Polyethylene glycol 4000 for treatment of functional constipation in children.

OBJECTIVES The aim of the study was to evaluate the effectiveness and safety of 2 different polyethylene glycol (PEG) doses for the maintenance treatment of functional constipation in children. METHODS Children with functional constipation according to the Rome III criteria were randomly assigned to receive PEG 4000 at a dose of either 0.7 g/kg (high-dose group; n = 45) or 0.3 g/kg (low-dose group; n = 47) for 6 weeks. Adjustment of the therapy was recommended in the event of <3 bowel movements (BM) per week or ≥3 BM per day. The primary outcome measure was treatment success, defined as ≥3 BM per week with no fecal soiling during the last week of the intervention. RESULTS A total of 90 of 92 randomized children, with a mean age of 3.7 ± 2.1 years, completed the study. In the analysis based on allocated treatment, treatment success was similar in both groups (relative risk 0.9, 95% confidence interval 0.78-1.03). Compared with the high-dose PEG group, the low-dose PEG group had an increased need for therapy adjustment of borderline significance (relative risk 2.0, 95% confidence interval 1.0-4.2), an increased risk of painful defecation, a lower number of stools per week, and lower parental satisfaction. Adverse events were similar in both groups. CONCLUSIONS To achieve treatment success, both tested doses of PEG were equally safe and effective in the treatment of children with functional constipation.