A randomized controlled trial of enemas in combination with oral laxative therapy for children with chronic constipation.

BACKGROUND & AIMS: After 5 years of intensive oral laxative use, up to 30% of constipated children still have an unsuccessful outcome. Children refractory to oral laxatives might benefit from regular rectal evacuation by enemas. This randomized controlled trial compared the effects of additional treatment with rectal enemas (intervention) with conventional treatment alone (oral laxatives, control) in severely constipated children.

METHODS: In a tertiary hospital in the Netherlands, 100 children, aged 8-18 years, with functional constipation for at least 2 years were randomly assigned to intervention or control groups. The control group received education, behavioral strategies, and oral laxatives. The intervention group was also given 3 rectal enemas/week, reduced by 1 enema/week every 3 months. Outcome measures were defecation and fecal incontinence frequency and overall success at 12, 26, 39, and 52 weeks. Overall success was defined as 3 or more defecations/week and less than 1 fecal incontinence episode/week, irrespective of laxative use.

RESULTS: Defecation frequency normalized in both groups but was significantly higher in the intervention group compared with controls at 26 and 52 weeks (5.6 vs 3.9/week, P = .02, and 5.3 vs 3.9/week, P = .02, respectively). There were no significant differences between groups in reduction of fecal incontinence episodes (P = .49) and overall success rates (P = .67). After 1 year of treatment, the overall success rate was 47.1% in the intervention group versus 36.1% in the control group.

CONCLUSIONS: There is no additional effect of enemas compared with oral laxatives alone as maintenance therapy for severely constipated children.