Trial reportGastroenterology2009
Multicenter, randomized, placebo-controlled trial of amitriptyline in children with functional gastrointestinal disorders.
Trial report in Gastroenterology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01269671 (Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain), which is not on this map. Cited by 67 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain
Who cites it
67 citing papers in PubMed, 7 syntheses or guidelines pooled it, 248 citations in OpenAlex.
- Comparative efficacy of probiotic, prebiotic, and synbiotic interventions in children with functional abdominal pain disorders: a systematic review and network meta-analysis.Frontiers in nutrition · 2026Pooled it
- ESPGHAN/NASPGHAN guidelines for treatment of irritable bowel syndrome and functional abdominal pain-not otherwise specified in children aged 4-18 years.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- Antidepressants for functional abdominal pain disorders in children and adolescents.The Cochrane database of systematic reviews · 2021Pooled it
- Pooled it
- Pharmacological interventions for recurrent abdominal pain in childhood.The Cochrane database of systematic reviews · 2017Pooled it
- Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome.The Cochrane database of systematic reviews · 2011Pooled it
- Antidepressants for the treatment of abdominal pain-related functional gastrointestinal disorders in children and adolescents.The Cochrane database of systematic reviews · 2011Pooled it
- Randomized Placebo-Controlled Trial of Psyllium Fiber in Functional Abdominal Pain Disorders in Children.Digestive diseases and sciences · 2026Trial
- Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study.Paediatric drugs · 2023Trial
- Assessment of abdominal pain through global outcomes and recent FDA recommendations in children: are we ready for change?Journal of pediatric gastroenterology and nutrition · 2014Trial
- Efficacy and tolerability of α-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial.BMC gastroenterology · 2013Trial
- Review
- Short-Course, Low-Dose Metoclopramide as Bridge Therapy for Dysautonomia-Associated Gastrointestinal Dysmotility in Adolescents: A Case Series.Children (Basel, Switzerland) · 2026Article
- Efficacy of Antidepressants in Treating Functional Abdominal Pain Disorders in Children: A Meta-Analysis of Randomized Controlled Trials.Pediatric gastroenterology, hepatology & nutrition · 2026Article
- Psychological Traits and Social Factors Associated with Irritable Bowel Syndrome in Children.Children (Basel, Switzerland) · 2026Article
- Recurrent Abdominal Pain in a Child - Evaluation and Management.Indian journal of pediatrics · 2025Review
- Anxiety and Depression in Children with Irritable Bowel Syndrome-A Narrative Review.Diagnostics (Basel, Switzerland) · 2025Review
- Fluoxetine for the Treatment of Abdominal Migraine.Indian journal of pediatrics · 2024Article
- Italian guidelines for the management of irritable bowel syndrome in children and adolescents : Joint Consensus from the Italian Societies of: Gastroenterology, Hepatology and Pediatric Nutrition (SIGENP), Pediatrics (SIP), Gastroenterology and Endoscopy (SIGE) and Neurogastroenterology and Motility (SINGEM).Italian journal of pediatrics · 2024Review
- The Pharmacological Treatment of Neuropathic Pain in Children.Current neuropharmacology · 2024Review
7 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
7 authors at 7 institutions in 1 country.
Funding
Abstract
BACKGROUND &
aimsThere 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.
methodsIn 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.
resultsNinety 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).
conclusionsBoth 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.