• Nicholas J Talley, G Richard Locke, Yuri A Saito, Ann E Almazar, Ernest P Bouras, Colin W Howden, Brian E Lacy, John K DiBaise, Charlene M Prather, Bincy P Abraham, Hashem B El-Serag, Paul Moayyedi, Linda M Herrick, Lawrence A Szarka, Michael Camilleri, Frank A Hamilton, Cathy D Schleck, Katherine E Tilkes, and Alan R Zinsmeister.
• Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia. Electronic address: Nicholas.Talley@newcastle.edu.au.
• Gastroenterology. 2015 Aug 1;149(2):340-9.e2.

Background & AimsAntidepressants are frequently prescribed to treat functional dyspepsia (FD), a common disorder characterized by upper abdominal symptoms, including discomfort or postprandial fullness. However, there is little evidence of the efficacy of these drugs in patients with FD. We performed a randomized, double-blind, placebo-controlled trial to evaluate the effects of antidepressant therapy on symptoms, gastric emptying (GE), and meal-induced satiety in patients with FD.MethodsWe performed a study at 8 North American sites of patients who met the Rome II criteria for FD and did not have depression or use antidepressants. Patients (n = 292; 44 ± 15 years old, 75% were female, 70% with dysmotility-like FD, and 30% with ulcer-like FD) were randomly assigned to groups given placebo, 50 mg amitriptyline, or 10 mg escitalopram for 10 weeks. The primary end point was adequate relief of FD symptoms for ≥5 weeks of the last 10 weeks (of 12). Secondary end points included GE time, maximum tolerated volume in Nutrient Drink Test, and FD-related quality of life.ResultsAn adequate relief response was reported by 39 subjects given placebo (40%), 51 given amitriptyline (53%), and 37 given escitalopram (38%) (P = .05, after treatment, adjusted for baseline balancing factors including all subjects). Subjects with ulcer-like FD given amitriptyline were >3-fold more likely to report adequate relief than those given placebo (odds ratio = 3.1; 95% confidence interval: 1.1-9.0). Neither amitriptyline nor escitalopram appeared to affect GE or meal-induced satiety after the 10-week period in any group. Subjects with delayed GE were less likely to report adequate relief than subjects with normal GE (odds ratio = 0.4; 95% confidence interval: 0.2-0.8). Both antidepressants improved overall quality of life.ConclusionsAmitriptyline, but not escitalopram, appears to benefit some patients with FD, particularly those with ulcer-like (painful) FD. Patients with delayed GE do not respond to these drugs. ClinicalTrials.gov ID: NCT00248651.Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

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