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Macrogol 3350 plus electrolytes for chronic constipation in children: a single-centre, open-label study
Winita Hardikar1, Noel Cranswick, Ralf G Heine
1Department of Gastroenterology and Clinical Nutrition, Royal Children's Hospital, Parkville, Victoria, Australia. winita.hardikar@rch.org.au
Insights
Macrogol 3350 plus electrolytes effectively treats chronic constipation in children aged 2-11 years, improving bowel movements and reducing abdominal pain. The treatment demonstrated a favorable safety profile with good tolerability in this pediatric population.
Area of Science:
- Pediatric Gastroenterology
- Pharmacological Interventions
- Digestive Health
Background:
- Chronic constipation is a common condition in children.
- Macrogol 3350-based laxatives are established for adult constipation.
- Pediatric safety and efficacy data for Macrogol 3350 were previously limited.
Purpose of the Study:
- To evaluate the safety and efficacy of Macrogol 3350 plus electrolytes.
- To assess treatment outcomes in children aged 2-11 years with chronic constipation.
- To determine the impact on bowel movement frequency and associated symptoms.
Main Methods:
- An open-label, non-randomized study involving 78 children (2-11 years) with chronic constipation.
- Treatment with Macrogol 3350 plus electrolytes for 12 weeks.
- Assessment of spontaneous defaecations, stool form, abdominal pain, and other efficacy variables.
Main Results:
- Significant increase in spontaneous defaecations per week (P < 0.001).
- Marked reduction in abdominal pain (P < 0.0001) and pain during defaecation (P < 0.0001).
- Treatment was well-tolerated, with most adverse events mild and unrelated to treatment.
Conclusions:
- Macrogol 3350 plus electrolytes is a safe and effective treatment for pediatric chronic constipation.
- The preparation shows significant improvements in efficacy variables and symptom resolution.
- High tolerability supports its use in children aged 2-11 years.
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.
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