Trial reportThe American journal of gastroenterology2016
Imipramine for Treatment of Esophageal Hypersensitivity and Functional Heartburn: A Randomized Placebo-Controlled Trial.
Trial report in The American journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 73 citations in OpenAlex.
- Efficacy of gut-brain neuromodulators in functional esophageal disorders: a systematic review.BMC gastroenterology · 2026Pooled it
- Guidelines on diagnosis and management of gastroesophageal reflux disease in infants, children and adolescents: a joint consensus from Italian pediatric societies (SIP and SIGENP) -Part II: management.Italian journal of pediatrics · 2026Guideline
- Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.Journal of pediatric gastroenterology and nutrition · 2018Guideline
- Reinterpreting Amitriptyline in Extra-esophageal Gastroesophageal Reflux Disease Through the GABAergic Inhibitory Axis.Journal of neurogastroenterology and motility · 2026Article
- Rome V Pediatric Upper Gastrointestinal Disorders of Gut-Brain Interaction.Gastroenterology · 2026Review
- Esophageal Reflux Hypersensitivity: A Comprehensive Review.Gut and liver · 2023Review
- Recent insights on functional heartburn and reflux hypersensitivity.Current opinion in gastroenterology · 2022Review
- Novel Advances in the Evaluation and Treatment of Children With Symptoms of Gastroesophageal Reflux Disease.Frontiers in pediatrics · 2022Review
- Comparative Efficacy of Antidepressants for Symptoms Remission of Gastroesophageal Reflux: A Bayesian Network Meta-analysis of Randomized Controlled Trials.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2021Review
- Pharmacological Management of Gastro-Esophageal Reflux Disease: An Update of the State-of-the-Art.Drug design, development and therapy · 2021Review
- The Spectrum of Reflux Phenotypes.Gastroenterology & hepatology · 2019Article
- Revisiting Montreal: New Insights into Symptoms and Their Causes, and Implications for the Future of GERD.The American journal of gastroenterology · 2019Review
- Outcomes From a Pharmacist - led Proton Pump Inhibitor Stewardship Program at a Single Institution.Hospital pharmacy · 2018Article
- Antidepressants vs. Placebo for the Treatment of Functional Gastrointestinal Disorders in Adults: A Systematic Review and Meta-Analysis.Frontiers in psychiatry · 2018Article
- Update on Functional Heartburn.Gastroenterology & hepatology · 2017Article
- Recent Advances in the Pharmacological Management of Gastroesophageal Reflux Disease.Digestive diseases and sciences · 2017Review
- The Prevalence of Rome IV Nonerosive Esophageal Phenotypes in Children.The Journal of pediatrics · 2017Article
- Imipramine for Treatment of Esophageal Hypersensitivity and Functional Heartburn.The American journal of gastroenterology · 2016Article
- Response to Marsden and Ford.The American journal of gastroenterology · 2016Article
- Tricyclic Antidepressants: What to Choose and Which Dose?The American journal of gastroenterology · 2016Article
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTricyclic antidepressants could be effective in the treatment of symptoms related to hypersensitive esophagus through their pain-modulating effect. We therefore assessed the benefit of imipramine in patients with esophageal hypersensitivity and functional heartburn.
methodsPatients with normal endoscopy findings and typical reflux symptoms despite standard-dose proton-pump inhibitor therapy underwent 24-h pH-impedance monitoring. Patients with established esophageal hypersensitivity or functional heartburn were randomly assigned to receive 8 weeks of either once-daily imipramine 25 mg (n=43) or placebo (n=40). The primary end point was satisfactory relief of reflux symptoms, defined as a >50% reduction in the gastroesophageal reflux disease score. The secondary end point was improvement in quality-of-life (QoL) as assessed by the 36-Item Short Form Health Survey score.
resultsPatients receiving imipramine did not achieve a higher rate of satisfactory relief of reflux symptoms than did patients receiving placebo (intention-to-treat (ITT) analysis: 37.2 vs. 37.5%, respectively; odds ratio (OR), 0.99; 95% confidence interval (CI), 0.41-2.41; per-protocol (PP) analysis: 45.5 vs. 41.2%, respectively; OR, 1.19; 95% CI, 0.45-3.13). Subgroup analysis to assess the efficacy of imipramine for either esophageal hypersensitivity or functional heartburn yielded similar results. Treatment with imipramine provided significant improvement of QoL by PP analysis (72±17 and 61±19, respectively; P=0.048), but ITT analysis did not reveal any differences between imipramine and placebo (68±19 and 61±19, respectively; P=0.26). Adverse events were similar in both groups; however, constipation was more common with imipramine than placebo (51.2 vs. 22.5%, respectively; P=0.01).
conclusionsAlthough low-dose imipramine shows potential QoL benefits, it does not relieve symptoms more effectively than does placebo in patients with either esophageal hypersensitivity or functional heartburn.
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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.