Publication: A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children
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Issued Date
2014
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eng
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Mahidol University
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BioMed Central
Bibliographic Citation
BMC Pediatrics. Vol. 14, (2014), 153
Suggested Citation
Suporn Treepongkaruna, Nipat Simakachorn, Paneeya Pienvichit, Wandee Varavithya, Yothi Tongpenyai, Garnier, Philippe, Hélène Mathiex-Fortunet A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children. BMC Pediatrics. Vol. 14, (2014), 153. doi:10.1186/1471-2431-14-153 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/2704
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Title
A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children
Abstract
Background: Chronic 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.
Methods: This 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.
Results: Stool 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.
Conclusions: PEG 4000 has superior efficacy to lactulose for the treatment of chronic constipation in young
children and is well tolerated.