Abstract

BackgroundChronic constipation is frequent in children. The objective of this study is to compare the efficacy and safety of PEG 4000 and lactulose for the treatment of chronic constipation in young children.MethodsThis randomised, double-blind study enrolled 88 young children aged 12 to 36 months, who were randomly assigned to receive lactulose (3.3 g per day) or PEG 4000 (8 g per day) for four weeks. The primary efficacy variable was stool frequency during the fourth week of treatment. Secondary outcomes were the number and frequency of subjective symptoms associated with defecation at each visit.ResultsStool frequency was comparable in the two groups at baseline (lactulose: 0.7 ± 0.5; PEG 4000: 0.5 ± 0.55). Mean stool frequency increased from 0.70 ± 0.50 stools/day at baseline to 0.80 ± 0.41 at Week 4 in the lactulose group and from 0.50 ± 0.55 to 1.10 ± 0.55 stools/day in the PEG 4000 group. A significant difference was observed in the adjusted mean change from baseline, which was 0.15 stools/day in the lactulose group and 0.51 stools/day in the PEG 4000 group, with a least-squares mean difference of 0.36 stools/day [95% CI: 0.16 to 0.56]. With respect to secondary outcome variables, stool consistency and ease of stool passage improved more in the PEG 4000 group (p = 0.001). The incidence of adverse events was similar in both groups, the majority of which were mild.ConclusionsPEG 4000 has superior efficacy to lactulose for the treatment of chronic constipation in young children and is well tolerated.Trial registrationUS National Institute of Health Clinical Trials database; study NCT00255372 first registered 17th November 2005.

Highlights

  • Constipation is an extremely common problem in children accounting for 3% of all visits to paediatric outpatient clinics and up to as many as 25% of all visits to paediatric gastroenterologists in the United States [1,2]

  • The occurrence of chronic constipation in children can lead to significant abdominal pain, appetite suppression, lowered self-esteem due to faecal incontinence, social isolation, feelings of depression, school absenteeism and family disruption [6]

  • The primary objective of the present study was to compare the efficacy of polyethylene glycol (PEG) 4000 to that of lactulose in the treatment of young children aged between 12 to 36 months with chronic constipation

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Summary

Introduction

The objective of this study is to compare the efficacy and safety of PEG 4000 and lactulose for the treatment of chronic constipation in young children. Constipation is an extremely common problem in children accounting for 3% of all visits to paediatric outpatient clinics and up to as many as 25% of all visits to paediatric gastroenterologists in the United States [1,2]. The prevalence of functional constipation in the community is not known with any precision, and prevalence rates ranging from 0.7% to 29.6% have been reported in the literature, with a median of 8.9% [3]. The occurrence of chronic constipation in children can lead to significant abdominal pain, appetite suppression, lowered self-esteem due to faecal incontinence, social isolation, feelings of depression, school absenteeism and family disruption [6]. Choices include lubricants, such as paraffin oil, osmotic laxatives, including lactulose, sorbitol, magnesium hydroxide and polyethylene glycol (PEG), and stimulant laxatives such as senna or bisacodyl

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