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PEG3350 in the treatment of childhood constipation: a multicenter, double-blinded, placebo-controlled trial
Samuel Nurko1, Nader N Youssef, Mahmoud Sabri
1Center for Motility and Functional Gastrointestinal Disorders, Children's Hospital Boston, MA 02115, USA. Samuel.Nurko@childrens.harvard.edu
Insights
Polyethylene glycol 3350 (PEG3350) effectively treats functional constipation in children. A starting dose of 0.4 g/kg per day is recommended for optimal efficacy and safety.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
Background:
- Functional constipation is a common pediatric issue.
- Effective short-term treatment options are crucial for improving children's quality of life.
Purpose of the Study:
- To determine the efficacy and optimal starting dose of polyethylene glycol 3350 (PEG3350) for short-term treatment of functional constipation in children.
- To compare PEG3350 efficacy against a placebo in a pediatric population.
Main Methods:
- A prospective, randomized, multicenter, double-blinded, placebo-controlled, dose-ranging study.
- Children received placebo or PEG3350 at 0.2, 0.4, or 0.8 g/kg/day for two weeks, alongside behavior modification.
- Treatment response was defined as at least three bowel movements in the second week.
Main Results:
- PEG3350 demonstrated significantly higher treatment success rates (73-77%) compared to placebo (42%).
- Significant improvements in bowel movement frequency and straining were observed with PEG3350.
- Higher doses (0.4 g/kg and above) improved stool consistency, but 0.8 g/kg was associated with increased abdominal pain and fecal incontinence.
Conclusions:
- Polyethylene glycol 3350 (PEG3350) is an effective and safe treatment for short-term management of functional constipation in children.
- A starting dose of 0.4 g/kg per day of PEG3350 is recommended.
- Further research may explore long-term efficacy and safety profiles.
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.
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