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Multicenter, randomized, placebo-controlled trial of amitriptyline in children with functional gastrointestinal

Miguel Saps1, Nader Youssef, Adrian Miranda

  • 1Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Children's Memorial Hospital, Northwestern University Feinberg School of Medicine, Chicago, Illinois 60614, USA. msaps@childrensmemorial.org

Gastroenterology
|July 15, 2009
PubMed

Insights

Amitriptyline did not show significant efficacy over placebo for treating pain in children with functional gastrointestinal disorders. While both treatments improved symptoms, amitriptyline specifically reduced anxiety scores in pediatric patients.

Area of Science:

  • Pediatric Gastroenterology
  • Clinical Pharmacology
  • Child Psychology

Background:

  • Functional gastrointestinal disorders (FGIDs) are common in children.
  • Pain is a predominant symptom in pediatric FGIDs.
  • Lack of high-quality trials on pharmacologic treatments for pediatric FGIDs.

Purpose of the Study:

  • To evaluate the efficacy of amitriptyline in treating pain-predominant FGIDs in children.
  • To compare amitriptyline with placebo in a randomized, double-blind trial.

Main Methods:

  • A multicenter, placebo-controlled trial involving 90 children with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia.
  • Participants received 4 weeks of either placebo or amitriptyline (10-20 mg/d based on weight).
  • Outcomes included overall treatment response, pain relief, psychosocial traits, and daily functioning, assessed via diaries and questionnaires.

Main Results:

  • No significant difference in overall treatment response between amitriptyline and placebo groups (63% vs 57.5% improved).
  • Pain relief levels were similar between amitriptyline and placebo groups (P=.85).
  • Amitriptyline significantly reduced anxiety scores (P < .0001), but baseline pain severity predicted worse outcomes in both groups.

Conclusions:

  • Amitriptyline and placebo demonstrated comparable therapeutic responses in children with pain-predominant FGIDs after 4 weeks.
  • Neither treatment showed a statistically significant advantage over the other for overall symptom improvement.
  • Patients with mild to moderate pain intensity experienced better treatment outcomes regardless of the group.
Abstract

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