Comparison of Polyethylene Glycol 3350+Electrolytes vs. Polyethylene Glycol 4000 for Fecal Disimpaction in Pediatric Functional Constipation: A Double-Blind Randomized Controlled Trial
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Purpose: Polyethylene glycol (PEG) is recommended as the first-line laxative for fecal disimpaction in pediatric functional constipation. PEG 3350+electrolyte (E) and PEG 4000 are the most commonly available formulations. PEG 3350+E and PEG 4000 have hypothesized benefits of lower risk of electrolyte imbalance and better palatability, respectively. However, a head-to-head comparison of these two formulations for fecal disimpaction remains lacking. This study aimed to compare the efficacy, tolerability, and acceptability of PEG 3350+E vs. PEG 4000 for fecal disimpaction in pediatric functional constipation. Methods: This double-blind, randomized controlled intention-to-treat trial included pediatric patients with functional constipation (as per ROME IV) and fecal impaction. Patients with organic constipation, h/o prior to gastrointestinal surgery, and those who were already receiving PEG/lactulose were excluded. Computer-generated block randomization was performed. Colorless liquid formulations of study medication were provided by investigator (JBK) as per treatment allocation in identical opaque bottles @1.5 gm/kg/dayx6 days or until fecal impaction resolution (passage of clear liquid stool), whichever is earlier. Results: One hundred patients were randomized in a 1:1 ratio (50 patients in each arm). Efficacy of PEG 3350+E vs. PEG 4000 was similar (84% vs. 86%; p=0.9). Similarly, no significant differences were noted in the adverse event rates between two groups. Abdominal discomfort and vomiting were the most common adverse effects. PEG 4000 showed better palatability than PEG 3350+E (p=0.044). However, there was no significant difference in the compliance rate. Conclusion: PEG 3350+E and PEG 4000 showed similar efficacies for fecal disimpaction, with minor side effects. PEG 4000 had better palatability; however, both were well tolerated by children.
Abstract
Purpose: Polyethylene glycol (PEG) is recommended as the first-line laxative for fecal disimpaction in pediatric functional constipation. PEG 3350+electrolyte (E) and PEG 4000 are the most commonly available formulations. PEG 3350+E and PEG 4000 have hypothesized benefits of lower risk of electrolyte imbalance and better palatability, respectively. However, a head-to-head comparison of these two formulations for fecal disimpaction remains lacking. This study aimed to compare the efficacy, tolerability, and acceptability of PEG 3350+E vs. PEG 4000 for fecal disimpaction in pediatric functional constipation. Methods: This double-blind, randomized controlled intention-to-treat trial included pediatric patients with functional constipation (as per ROME IV) and fecal impaction. Patients with organic constipation, h/o prior to gastrointestinal surgery, and those who were already receiving PEG/lactulose were excluded. Computer-generated block randomization was performed. Colorless liquid formulations of study medication were provided by investigator (JBK) as per treatment allocation in identical opaque bottles @1.5 gm/kg/dayx6 days or until fecal impaction resolution (passage of clear liquid stool), whichever is earlier. Results: One hundred patients were randomized in a 1:1 ratio (50 patients in each arm). Efficacy of PEG 3350+E vs. PEG 4000 was similar (84% vs. 86%; p=0.9). Similarly, no significant differences were noted in the adverse event rates between two groups. Abdominal discomfort and vomiting were the most common adverse effects. PEG 4000 showed better palatability than PEG 3350+E (p=0.044). However, there was no significant difference in the compliance rate. Conclusion: PEG 3350+E and PEG 4000 showed similar efficacies for fecal disimpaction, with minor side effects. PEG 4000 had better palatability; however, both were well tolerated by children.