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

Abstract：

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.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Saps M,Youssef N,Miranda A,Nurko S,Hyman P,Cocjin J,Di Lorenzo C

doi

10.1053/j.gastro.2009.06.060

subject

Has Abstract

pub_date

2009-10-01 00:00:00

pages

1261-9

issue

eissn

0016-5085

issn

1528-0012

pii

S0016-5085(09)01148-2

journal_volume

137

pub_type

杂志文章,多中心研究,随机对照试验

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