A prospective, double-blind, randomized, placebo-controlled trial comparing the efficacy of polyethylene glycol versus polyethylene glycol combined with topical diltiazem for treating anal fissure in children
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In brief
In brief
Randomized controlled trial of 48 children with anal fissure found that polyethylene glycol (PEG) alone achieved similar symptom resolution compared to PEG combined with topical diltiazem at 12 weeks. Results suggest adding diltiazem provides no additional benefit over PEG monotherapy for pediatric anal fissure management.
Written by the GCMD Library team from the article.
Background
Anal fissure (AF) in children is usually treated with laxatives and/or topical agents such as calcium channel blockers. We hypothesize that owing to the superior efficacy of Polyethylene glycol (PEG) in treating constipation in children, adding diltiazem (DTZ) might not improve healing of AF.
Methods
Children ≤14 years with anal fissure presented to the pediatric surgery clinic between November 2014 and March 2016 were recruited. Randomization was performed to either PEG with DTZ or PEG with placebo. Study personnel, patients, and their families were blinded. Primary outcome was resolution of symptoms. Secondary outcomes were constipation and treatment complications at 12-week follow up.
Results
48 patients were randomized: 24 to PEG + DTZ and 24 to PEG + placebo. Both groups were similar in their baseline characteristics. At week 12, majority of patients' symptoms have improved without significant difference between groups; painful defecation at week 12: 20.8% and 8.3% (p-value 0.41), blood per rectum at week 12: 4.2% and 8.3% (p value 0.58) in the DTZ and placebo groups, respectively. Additionally, there was similar improvement in constipation in both groups.
Conclusion
PEG alone was associated with similar improvement in anal fissure symptoms in children compared to PEG and topical diltiazem combined.
Level of evidence
I