Response and Recurrence Rate After Treatment With Polyethylene Glycol Versus Polyethylene Glycol Plus Lactulose in Children With Chronic Functional Constipation: A Randomized Controlled Trial

Abstract

Background: Constipation is a common symptom in children and can cause significant distress to parents. Objectives: The aim of this study was to investigate the response and recurrence rate after treatment with polyethylene glycol alone versus polyethylene glycol plus lactulose in children with chronic functional constipation. Patients and Methods: In this randomized controlled trial study, 200 patients aged 1 to 12 years with functional constipation based on the ROME III criteria, were divided into two identical therapeutic groups; group I received polyethylene glycol (PEG) alone and group II received PEG and lactulose. Participants were treated for one month and responsive patients were followed prospectively at 3, 6, and 12 months to assess the recurrence. Results: The response rate to treatment was 70% in group I and 87% in group II (P value 0.003). Recurrence rate was 15.9% in group I and 10.3% in group II (P value 0.3). Factors such as positive family history, sex, age onset of constipation, low fiber diet, toileting, and fecal incontinence did not significantly contribute to success rate of treatment or recurrence rate in the both groups. Conclusions: There was no significant lower recurrence rate of constipation with PEG and lactulose combination therapy over PEG alone. Therefore, changing treatment from lactulose plus PEG to PEG alone would result in better compliance of patients for long-term therapy and would be cost effective.