Comparative efficacy of polyethylene glycol 3350 and psyllium in treatment of pediatric functional constipation: A randomized and controlled trial

Abstract

Background: Functional constipation (FC) is a common childhood problem worldwide. At present, polyethylene glycol (PEG) is considered as standard therapy in pediatric FC patients. Aims and Objectives: The aim of the study was to compare the efficacy of PEG 3350 versus psyllium in treatment of pediatric FC. Materials and Methods: All children (aged >1 year) diagnosed with FC according to Rome IV criteria and presenting to the outpatient department of Pediatric Gastroenterology, Hepatology, and Nutrition Unit of a tertiary health center in North Indian Himalayan state were randomized into two open label, prospective, parallel groups, namely, Group A (receiving PEG 3350) and Group B (receiving psyllium), over a period of 16 months. The comparative efficacy was evaluated by comparing the percent of patients with successful outcomes in two groups at 4, 8, and 12 weeks of therapy and the rate of recurrence of impaction in two groups was also assessed and compared over same period. Results: Eighty-one patients were randomized into two groups. A significantly higher number of patients in Group A was successfully treated after 4 weeks (Group A 68.3% vs. Group B 42.5%; P = 0.026), 8 weeks (Group A 80.0% vs. Group B 57.9%; P = 0.049), and 12 weeks (Group A 92.3% vs. Group B 67.6%; P = 0.009) of treatment compared with Group B. Impaction recurred in two patients in Group B while no recurrence was observed in any of the Group A patients but the difference observed was not statistically significant (P = 0.494). No significant adverse events were reported in either groups. Conclusion: PEG 3350 was found to be significantly more effective than psyllium in improving the symptoms of constipation in pediatric patients.