Macrogol 3350 plus electrolytes for chronic constipation in children: a single-centre, open-label study.

AIM

A Macrogol 3350-based, iso-osmotic laxative has become available for the treatment of chronic constipation in adults. This open-label, non-randomised study aimed to evaluate the safety and efficacy of this preparation in the treatment of chronic constipation in children.

METHODS

Seventy-eight children, aged 2-11 years, with chronic constipation for greater than 3 months were enrolled. All children received Macrogol 3350 plus electrolytes for 12 weeks. The primary efficacy variable was the number of spontaneous defaecations per week. Secondary efficacy variables were faecal form, abdominal pain, rectal bleeding, pain on defaecation, straining, soiling, amount of stool, stool withholding and assessments of efficacy by the investigators and parents. Safety and compliance were also assessed.

RESULTS

The mean number of spontaneous defaecations per week increased from 1.4 +/- 0.55 (SD) at baseline to 6.8 +/- 3.45 after 14 days, and 7.1 +/- 3.45 at 12 weeks (P < 0.001). Similar improvements were found in the secondary efficacy variables. There was a significant reduction in reported abdominal pain from 53 (69%) children at baseline to 3 (4%) at the final visit (P < 0.0001). Similarly, 61 (79%) children had pain on defaecation at baseline, compared with 7 (9%) at the final visit (P < 0.0001). Treatment was well tolerated. Of 318 adverse events, 262 (82%) were considered mild, and 241 (76%) were deemed unrelated to treatment. Only 3 (4%) children were withdrawn because of poor compliance.

CONCLUSIONS

Macrogol 3350 plus electrolytes is a safe and effective treatment for constipation in children aged 2-11 years.