OBJECTIVES: The aim of the study was to evaluate the effectiveness and safety of 2 different polyethylene glycol (PEG) doses for the maintenance treatment of functional constipation in children. METHODS:Children with functional constipation according to the Rome III criteria were randomly assigned to receive PEG 4000 at a dose of either 0.7 g/kg (high-dose group; n = 45) or 0.3 g/kg (low-dose group; n = 47) for 6 weeks. Adjustment of the therapy was recommended in the event of <3 bowel movements (BM) per week or ≥3 BM per day. The primary outcome measure was treatment success, defined as ≥3 BM per week with no fecal soiling during the last week of the intervention. RESULTS:A total of 90 of 92 randomized children, with a mean age of 3.7 ± 2.1 years, completed the study. In the analysis based on allocated treatment, treatment success was similar in both groups (relative risk 0.9, 95% confidence interval 0.78-1.03). Compared with the high-dose PEG group, the low-dose PEG group had an increased need for therapy adjustment of borderline significance (relative risk 2.0, 95% confidence interval 1.0-4.2), an increased risk of painful defecation, a lower number of stools per week, and lower parental satisfaction. Adverse events were similar in both groups. CONCLUSIONS: To achieve treatment success, both tested doses of PEG were equally safe and effective in the treatment of children with functional constipation.
RCT Entities:
OBJECTIVES: The aim of the study was to evaluate the effectiveness and safety of 2 different polyethylene glycol (PEG) doses for the maintenance treatment of functional constipation in children. METHODS:Children with functional constipation according to the Rome III criteria were randomly assigned to receive PEG 4000 at a dose of either 0.7 g/kg (high-dose group; n = 45) or 0.3 g/kg (low-dose group; n = 47) for 6 weeks. Adjustment of the therapy was recommended in the event of <3 bowel movements (BM) per week or ≥3 BM per day. The primary outcome measure was treatment success, defined as ≥3 BM per week with no fecal soiling during the last week of the intervention. RESULTS: A total of 90 of 92 randomized children, with a mean age of 3.7 ± 2.1 years, completed the study. In the analysis based on allocated treatment, treatment success was similar in both groups (relative risk 0.9, 95% confidence interval 0.78-1.03). Compared with the high-dose PEG group, the low-dose PEG group had an increased need for therapy adjustment of borderline significance (relative risk 2.0, 95% confidence interval 1.0-4.2), an increased risk of painful defecation, a lower number of stools per week, and lower parental satisfaction. Adverse events were similar in both groups. CONCLUSIONS: To achieve treatment success, both tested doses of PEG were equally safe and effective in the treatment of children with functional constipation.
Authors: Mohammad Reza Esmaeilidooki; Seyyed Ali Mozaffarpur; Mohaddese Mirzapour; Hoda Shirafkan; Mohammad Kamalinejad; Ali Bijani Journal: Iran Red Crescent Med J Date: 2016-05-11 Impact factor: 0.611
Authors: Mohammad Hadi Imanieh; Mohammad Reza Golpayegan; Mostafa Sedighi; Kamal Ahmadi; Abbas Aghaie; Seyed Mohsen Dehghani; Gholamreza Yousefi Journal: Prz Gastroenterol Date: 2019-05-08
Authors: Noor L H Bekkali; Daniël R Hoekman; Olivia Liem; Marloes E J Bongers; Michiel P van Wijk; Bas Zegers; Rolf A Pelleboer; Wim Verwijs; Bart G P Koot; Maksym Voropaiev; Marc A Benninga Journal: J Pediatr Gastroenterol Nutr Date: 2018-01 Impact factor: 2.839
Authors: Anthony Lamanna; Lauren D Dughetti; Julie A Jordan-Ely; Kyla M Dobson; Megan Dynan; Adeline Foo; Louise M P Kooiman; Naomi Murakami; Kaic Fiuza; Siavash Foroughi; Marcelo Leal; Suzanna Vidmar; Anthony G Catto-Smith; John M Hutson; Bridget R Southwell Journal: JGH Open Date: 2018-06-27