Loening-Baucke, V., & Pashankar, D.S. (2006). A randomized, prospective, comparison study of polyethylene glycol 3350 without electrolytes and milk of magnesia for children with constipation and fecal incontinence. Pediatrics, 118, 528–535.

To compare and evaluate the efficacy, safety, acceptance, and one-year outcome of two laxatives, polyethylene glycol (PEG) without electrolytes and milk of magnesia (MOM).

Patients were randomly assigned to intervention with PEG 3350 without electrolytes (Miralax^®) or MOM by drawing a sealed envelope. Patients initially received 0.7 g/kg of PEG or 2 ml/kg of MOM daily.

• A total of 117 children were asked to participate; 79 were enrolled and randomized.
• The PEG group comprised 39 patients (31 boys and 8 girls), whereas the MOM group comprised 40 patients (34 boys and 6 girls).
• Patients were included in the study if they were new referrals (more than one per week), were aged four years or older, and had presence of functional constipation with fecal incontinence.
• Patients were excluded if they had stool toileting refusal, fecal incontinence without constipation, previously refused one of the study medications, Hirschsprung disease, previous surgery involving the colon, chronic intestinal pseudo-obstruction, or come for a second opinion.

Children’s Hospital of Iowa

Randomized controlled trial

• Improvement was defined as three or more bowel movements (BMs) per week and two or fewer episodes of fecal incontinence per month with no abdominal pain, with or without laxative.
• Recovery was defined as three or more BMs per week and two or fewer episodes of fecal incontinence per month with no abdominal pain, without laxative treament for at least one month.
• Children who received additional senna were counted as not improved or recovered.

• Baseline characteristics were not significant (p > 0.07).
• Compliance rates were significant at 95% for the PEG group and 65% for the MOM group.
• After 12 months, 62% of the PEG group and 43% of the MOM group exhibited improvement and 33% of the PEG group and 23% of the MOM group recovered (not significant).

PEG and MOM are effective and safe in long-term treatment, with PEG having better acceptance.

• The study had a high drop-out rate (loss to follow-up).
• The study did not measure biochemical profiles for all children.