Medline ® Abstract for Reference 67
of 'Chronic functional constipation and fecal incontinence in infants and children: Treatment'
PEG3350 in the treatment of childhood constipation: a multicenter, double-blinded, placebo-controlled trial.
Nurko S, Youssef NN, Sabri M, Langseder A, McGowan J, Cleveland M, Di Lorenzo C
J Pediatr. 2008;153(2):254. Epub 2008 Mar 19.
OBJECTIVE: To establish the efficacy and best starting dose of polyethylene glycol (PEG)3350 in the short-term treatment of children with functional constipation.
STUDY DESIGN: Prospective, randomized, multicenter, double-blinded, placebo-controlled, dose-ranging study of PEG3350 in children with functional constipation. Patients were randomly assigned to either placebo or 0.2 g/kg per day, 0.4 g/kg per day, or 0.8 g/kg per day of PEG3350 after a 1 week run-in period, followed by 2 weeks of treatment. All received behavior modification. The primary outcome was the proportion of patients with a successful treatment response:>or=3 bowel movements (BM) in the second week.
RESULTS: 103 children (mean, 8.5 +/- 3.1 years) were enrolled. 77%, 74%, and 73% of the 0.2, 0.4, and 0.8 g/kg groups were successfully treated, as compared with 42% receiving placebo (P<.04). There was a significant increase in BM (P<.001) and straining improvement (P<.05) with the different PEG3350 doses. Stool consistency improved significantly for doses 0.4 g/kg or higher (P<.001). There was more abdominal pain and fecal incontinence in patients receiving 0.8 g/kg. PEG3350 was well tolerated.
CONCLUSIONS: This placebo-controlled study confirms the efficacy and safety of PEG3350 for the short-term treatment of children with functional constipation. We recommend a starting dose of 0.4 g/kg per day.
Center for Motility and Functional Gastrointestinal Disorders, Children's Hospital Boston, MA 02115, USA. Samuel.Nurko@childrens.harvard.edu