Multicenter, randomized, placebo-controlled trial of amitriptyline in children with functional gastrointestinal disorders. Gastroenterology 2009 Oct;137(4):1261-9
Date
07/15/2009Pubmed ID
19596010Pubmed Central ID
PMC2827243DOI
10.1053/j.gastro.2009.06.060Scopus ID
2-s2.0-70349420923 (requires institutional sign-in at Scopus site) 192 CitationsAbstract
BACKGROUND & AIMS: There are no prospective, multicenter, double-blind, placebo-controlled, randomized pharmacologic trials for the treatment of pain-predominant functional gastrointestinal disorders in children. The aim of this study was to evaluate the efficacy of amitriptyline in children with pain-predominant functional gastrointestinal disorders.
METHODS: In this multicenter placebo-controlled trial, children with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia were randomized to 4 weeks of placebo or amitriptyline (10 mg/d, weight <35 kg; 20 mg/d, weight >35 kg). Assessment of gastrointestinal symptoms, psychological traits, and daily activities occurred before and after intervention. Pain was assessed daily with self-report diaries. The primary outcome was overall response to treatment (child's assessment of pain relief and sense of improvement). Secondary outcomes were effect on psychosocial traits and daily functioning.
RESULTS: Ninety children were enrolled, and 83 completed the study (placebo, 40 children [30 girls]; drug, 43 children [35 girls]). A total of 63% of patients reported feeling better and 5% feeling worse in the amitriptyline arm compared with 57.5% feeling better and 2.5% feeling worse in the placebo arm (P = .63). Pain relief was excellent in 7% and good in 38% of children receiving placebo compared with excellent in 15% and good in 35% of children treated with amitriptyline (P = .85). Logistic regression analysis of those reporting excellent or good response versus fair, poor, or failed response showed no difference between amitriptyline and placebo (P = .83). Children who had more severe pain at baseline in both groups (P = .0065) had worse outcome. Amitriptyline reduced anxiety scores (P < .0001).
CONCLUSIONS: Both amitriptyline and placebo were associated with excellent therapeutic response. There was no significant difference between amitriptyline and placebo after 4 weeks of treatment. Patients with mild to moderate intensity of pain responded better to treatment.
Author List
Saps M, Youssef N, Miranda A, Nurko S, Hyman P, Cocjin J, Di Lorenzo CAuthor
Adrian Miranda MD Adjunct Professor in the Pediatrics department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Abdominal PainActivities of Daily Living
Adolescent
Amitriptyline
Analgesics, Non-Narcotic
Anxiety
Child
Dyspepsia
Female
Gastrointestinal Agents
Humans
Irritable Bowel Syndrome
Logistic Models
Male
Medication Adherence
Pain Measurement
Prospective Studies
Severity of Illness Index
Surveys and Questionnaires
Time Factors
Treatment Outcome
United States
