Dr Christophe Dupont and colleagues assessed the safety of a polyethylene glycol 4000 laxative without additional salts in pediatric patients.
The research team conducted a 3-month multicenter, randomized, double-blind, double-dummy, lactulose-controlled, parallel study.
The team enrolled 96 ambulatory constipated children aged 6 months to 3 years, treated daily with 4 to 8 g polyethylene glycol 4000 or 4 to 7 g lactulose.
Total protein, albumin, iron, electrolytes, and vitamins B9, A and D were measured in blood before and after treatment in a central laboratory.
The percentage of children with at least 1 value out of normal range at day 84 with respect to baseline status was 87% in the polyethylene glycol 4000 Group.
| Polyethylene glycol 4000 showed higher improvements for stool consistency and appetite |
|Journal of Pediatric Gastroenterology & Nutrition|
The team found that the proportion of children with at least 1 value out of normal range at day 84 was 90% in the lactulose Group.
The team reported no difference between the groups for this primary endpoint.
The whole blood parameters showed no qualitative or quantitative treatment-related changes.
The researchers observed that in the polyethylene glycol 4000 group, Vitamin A values were above normal range in 56% at baseline vs 33% at day 84.
For the lactulose group, 41% of children were above normal range for Vitamin A values at baseline, with 36% at day 84.
The team noted that iron values were under normal range in 47% at baseline vs 42% at day 84 in the polyethylene glycol 4000 group.
The researchers observed similar under normal range values for iron in the lactulose group in 51% both at baseline and at day 84.
Clinical tolerance was similar for both treatments except for vomiting and flatulence, which were significantly higher with lactulose.
In addition, the team noted higher improvements with polyethylene glycol 4000 regarding stool consistency, appetite, fecaloma and use of additional laxatives.
Dr Dupont's team concluded, “This 3-month study in 96 constipated children aged 6 months to 3 years confirms the long-term tolerance of polyethylene glycol 4000 in pediatrics.”
“The results indicate a polyethylene glycol 4000 efficacy similar to or greater than that of lactulose.”