Polyethylene glycol 3350 plus electrolytes for chronic constipation in children: a double blind, placebo controlled, crossover study

Michael A Thomson ^1*, huw jenkins ², W michael bisset ³, rob heuschkel ⁴, d kalra ⁵, mike green ⁶, david wilson ⁷ and Mike Geraint ⁸

¹ Sheffield Children's Hospital NHS Foundation Trust, United Kingdom
² Department of Child Health, University Hospital of Wales, United Kingdom
³ Department of Paediatric Gastroenterology, Royal Aberdeen Children's Hospital, United Kingdom
⁴ Centre for Paediatric Gastroenterology, Royal Free Hospital, United Kingdom
⁵ Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital, United Kingdom
⁶ Children's Hospital, University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary, United Kingdom
⁷ Paediatric Gastroenterology and Nutrition Department, Royal Hospital for Sick Children, United Kingdom
⁸ Norgine Ltd, Chaplin House, United Kingdom

^* To whom correspondence should be addressed. E-mail: mike.thomson{at}sch.nhs.uk.

Accepted 23 May 2007

Abstract

Objectives: To assess the efficacy and safety of polyethylene glycol 3350 plus electrolytes (PEG+E) for the treatment of chronic constipation in children.

Design: Randomised, double blind, placebo controlled crossover trial, with two 2-week treatment periods separated by a 2-week placebo washout.

Setting: Six UK paediatric departments.

Participants: 51 children (29 girls, 22 boys) aged 24 months to 11 years with chronic constipation (lasting "d 3 months), defined as "T 2 complete bowel movements per week, and at least one of the following: pain on defaecation on 25% of days; "d 25% of bowel movements with straining;"d 25% of bowel movements with hard or lumpy stools. Forty-seven children completed the double blind treatment.

Main outcome measures: Number of complete defaecations per week (primary efficacy variable), total number of complete and incomplete defaecations per week, pain on defaecation, straining on defaecation, faecal incontinence, stool consistency, global assessment of treatment, adverse events, physical examination.

Results: The mean number of complete defaecations per week was significantly higher for children on PEG+E than for children on placebo (3.12 (SD 2.05) v 1.45 (SD 1.20), respectively; p < 0.001). Further significant differences in favour of PEG+E were observed for total number of defaecations per week (p= 0.003), pain on defaecation (p = 0.041), straining on defaecation (p< 0.001), stool consistency (p < 0.001), and percentage of hard stools (p= 0.001). Treatment related adverse events (all mild or moderate) occurred in similar numbers of children on PEG+E (41%) and placebo during treatment (45%).

Conclusions: PEG+E is significantly more effective than placebo, and appears to be safe and well tolerated in the treatment of chronic constipation in children.

Keywords: childhood, constipation, laxatives, macrogol, polyethylene glycol

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Howard Bauchner, Editor-in-
Arch. Dis. Child. 2007 92: 1. [Extract] [Full Text] [PDF]

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