PEG3350 in the treatment of childhood constipation: a multicenter, double-blinded, placebo-controlled trial.
OBJECTIVE
To establish the efficacy and best starting dose of polyethylene glycol (PEG)3350 in the short-term treatment of children with functional constipation.


METHODS
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.
Nurko
Samuel
S
Center for Motility and Functional Gastrointestinal Disorders, Children's Hospital Boston, MA 02115, USA. Samuel.Nurko@childrens.harvard.edu
Youssef
Nader N
NN
Sabri
Mahmoud
M
Langseder
Annette
A
McGowan
John
J
Cleveland
Mark
M
Di Lorenzo
Carlo
C
D002648:Child; D003248:Constipation / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054368:Laxatives / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
D054368:Laxatives; D011092:Polyethylene Glycols