Long-term Efficacy and Safety of Polyethylene Glycol as Maintenance Treatment for Childhood Functional Constipation

Table of Content

Background

Functional constipation (FC) is a common pediatric problem. Guidelines recommend maintenance treatment to ensure soft, painless stools, and to prevent relapse of constipation. Nevertheless, there is a dearth of evidence to demonstrate the benefits and success of long-term maintenance treatment.

Aim

To determine the long-term efficacy of polyethylene glycol (PEG) during maintenance treatment of childhood FC

Patient Profile

  • Children with FC as per the Rome III criteria (age; 2–16 years, n=115)

Methods

Study Design

  • Randomized, double-blinded, single-centered, placebo-controlled trial

Treatment Strategy

  • Children were randomized 1:1 to PEG (n=58) or placebo (n=57) after disimpaction
  • The maintenance dose of 0.8 g/kg/day PEG was increased to maximum of 1.5 g/kg/day in case of recurrence of FC
  • The medication was planned to be used for at least 8 weeks before gradually weaning it off
  • Children reporting treatment failure before 24 weeks were switched to conventional treatment.

Outcomes

Primary Outcome

  • Successful treatment (defined as absence of any Rome III criteria with or without use of medication after 24 weeks)

Safety Outcome

  • Incidence and severity of adverse events

Follow-up Visits

  • Personal visits at week 1, 2, 8 and 24
  • Planned telephone consultations at week 4 and 12

Results

  • The final analysis included 95 children, 47 in PEG group and 48 in placebo group.
  • At 24 weeks, a significantly greater proportion of patients in the PEG group were treated successfully as compared with  the placebo group (hazard ratio ; 3.21; 95% confidence intervals ,1.73–5.94) (Figure 1).
Figure 1: Treatment success in the study groups
  • Significantly fewer children in the PEG group vs. the placebo group switched to rescue medication (4% vs. 57%, P<0.001).
  • Time before the change to rescue medication was 13 and 27 days, respectively, for each of the 2 children in the PEG group who required rescue medication. Amongst the children in the placebo group, median time to shift to rescue medication was 27 days (range: 3–64 days).
  • The incidence of fecal incontinence (FI) decreased from baseline to 24 months in PEG (from 51% to 29%) as well as in placebo group (from 44% to 26%)
  • No serious adverse event related to use of the study medication were recorded during the study.

Conclusions

  • Long-term maintenance treatment with PEG was significantly more effective than placebo for preventing relapse of constipation for childhood FC.
  • Relapse typically occurred within the first 9 weeks after disimpaction. It is therefore recommended that maintenance treatment should commence after disimpaction.
  • Long-term maintenance treatment with PEG up to 24 weeks was not associated with any significant adverse events and can be safely be used in the pediatric population.

J Pediatr Gastroenterol Nutr. 2018;67: 732–737.