Efficacy, safety, and acceptability of polyethylene glycol 3350 without electrolytes vs magnesium hydroxide in functional constipation in children from six months to eighteen years of age: A controlled clinical trial.
Study Goal
The researchers aimed to compare the efficacy, safety, and acceptability of polyethylene glycol (PEG) 3350 and magnesium hydroxide (MH) as long-term treatments for functional constipation in pediatric patients aged 6 months to 18 years.
Results Summary
Both PEG 3350 and MH were equally effective and safe for treating functional constipation in children, with no significant differences in success rates or adverse events. However, PEG 3350 had better acceptability in patients above 4 years of age.
Population
Pediatric patients aged 6 months to 18 years diagnosed with functional constipation.
Effective Dosage
Not specified in the abstract.
Duration
12 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
polyethylene glycol (PEG) 3350 | no change | success (≥ 3 bowel movements/week, with no fecal incontinence, fecal impaction, abdominal pain, or the need for another laxative) | patients from 6 months to 18 years of age diagnosed with functional constipation | 40/41 vs 40/42, p = 0.616 | no differences in success | #1 |
magnesium hydroxide (MH) | no change | success (≥ 3 bowel movements/week, with no fecal incontinence, fecal impaction, abdominal pain, or the need for another laxative) | patients from 6 months to 18 years of age diagnosed with functional constipation | 40/42 vs 40/41, p = 0.616 | no differences in success | #2 |
polyethylene glycol (PEG) 3350 | no change | acceptability (measured as rejected doses of the laxative) | patients from 6 months to 18 years of age diagnosed with functional constipation | - | no differences in acceptability | #3 |
magnesium hydroxide (MH) | no change | acceptability (measured as rejected doses of the laxative) | patients from 6 months to 18 years of age diagnosed with functional constipation | - | no differences in acceptability | #4 |
magnesium hydroxide (MH) | decrease | acceptability (measured as rejected doses of the laxative) | subgroups > 4 to 12 years of age | P = .037 | statistically significant higher number of patients rejected | #5 |
magnesium hydroxide (MH) | decrease | acceptability (measured as rejected doses of the laxative) | subgroups > 12 to 18 years of age | P = .020 | statistically significant higher number of patients rejected | #6 |
polyethylene glycol (PEG) 3350 | no change | adverse events | patients from 6 months to 18 years of age diagnosed with functional constipation | - | no differences regarding adverse events | #7 |
magnesium hydroxide (MH) | no change | adverse events | patients from 6 months to 18 years of age diagnosed with functional constipation | - | no differences regarding adverse events | #8 |
polyethylene glycol (PEG) 3350 | no change | treating functional constipation | children from 0.5 to 18 years of age | - | equally effective and safe | #9 |
magnesium hydroxide (MH) | no change | treating functional constipation | children from 0.5 to 18 years of age | - | equally effective and safe | #10 |
polyethylene glycol (PEG) 3350 | increase | acceptance | patients above 4 years of age | - | acceptance was better | #11 |
magnesium hydroxide (MH) | no change | treating functional constipation | children under 4 years of age | - | can be considered first-line treatment | #12 |
INTRODUCTION AND AIMS: There are few studies that compare polyethylene glycol (PEG) 3350 and magnesium hydroxide (MH), as long-term treatment of functional constipation (FC) in children, and they do not include infants as young as 6 months of age. Our aim was to determine the efficacy, safety, and acceptability of PEG vs MH in FC, in the long term, in pediatric patients. METHODS: An open-label, parallel, controlled clinical trial was conducted on patients from 6 months to 18 years of age, diagnosed with FC, that were randomly assigned to receive PEG 3350 or MH for 12 months. Success was defined as: ≥ 3 bowel movements/week, with no fecal incontinence, fecal impaction, abdominal pain, or the need for another laxative. We compared adverse events and acceptability, measured as rejected doses of the laxative during the study, in each group and subgroup. RESULTS: Eighty-three patients with FC were included. There were no differences in success between groups (40/41 PEG vs 40/42 MH, p = 0.616). There were no differences in acceptability between groups, but a statistically significant higher number of patients rejected MH in the subgroups > 4 to 12 years and > 12 to 18 years of age (P = .037 and P = .020, respectively). There were no differences regarding adverse events between the two groups and no severe clinical or biochemical adverse events were registered. CONCLUSIONS: The two laxatives were equally effective and safe for treating FC in children from 0.5 to 18 years of age. Acceptance was better for PEG 3350 than for MH in patients above 4 years of age. MH can be considered first-line treatment for FC in children under 4 years of age.