Original ResearchFull Report: Clinical—Alimentary TractEffect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study
Section snippets
Study Overview
This National Institutes of Health (DK065713)−funded, multicenter, randomized double-blind parallel group trial (Clinicaltrials.gov ID: NCT00248651) comparing 12 weeks of amitriptyline, escitalopram, and matching placebo pills is summarized in Figure 1. Institutional Review Board approval was obtained at each site. Written informed consent was obtained from each subject. Mayo Clinic Rochester monitored each site, centralized data storage, and analyzed the data. Data and Safety Monitoring Board
Subjects
Overall, 399 FD patients were screened at 8 sites (Figure 2). A total of 341 individuals met eligibility criteria and 292 subjects (97 placebo, 97 amitriptyline, and 98 escitalopram) were randomized. Sample demographic and physiologic characteristics are summarized in Table 2. Mean age was 44 years, 219 (75%) were female, and 250 (86%) were Caucasian. A total of 289 (99%) had documented endoscopy data within 5 years of recruitment; 231 (80%) had an endoscopy within a year of recruitment. Median
Discussion
Because the pathophysiology of FD remains poorly understood and a variety of treatment classes are available, health care providers do face uncertainty in selecting therapies for patients with FD. Options used in practice with limited or no data include antispasmodics, analgesics, over-the-counter remedies, as well as antidepressants to treat visceral hypersensitivity.8 This multicenter randomized, double-blind, placebo-controlled trial comparing placebo, amitriptyline, and escitalopram in FD
Acknowledgments
The investigators would like to thank the National Institute of Diabetes and Digestive and Kidney Diseases staff (Dr Patricia Roebuck, Rebecca Torrance, Rebekkah Van Raaphorst, Dr Frank Hamilton, and Dr Jose Serrano); the Data and Safety Monitoring Board members (Drs Henry Parkman, Brooks Cash, William Chey, Rona Levy, James Tonascia); the study coordinators (Verna J. Skinner, Mayo Clinic Jacksonville; Jason Bratten, Northwestern University; Jessica Chevalier, Dartmouth-Hitchcock Medical
References (40)
- et al.
Non-ulcer dyspepsia and duodenal eosinophilia: an adult endoscopic population-based case-control study
Clin Gastroenterol Hepatol
(2007) - et al.
Prevalence and socioeconomic impact of upper gastrointestinal disorders in the United States: results of the US Upper Gastrointestinal Study
Clin Gastroenterol Hepatol
(2005) - et al.
Symptoms associated with hypersensitivity to gastric distention in functional dyspepsia
Gastroenterology
(2001) - et al.
Functional dyspepsia impacts absenteeism and direct and indirect costs
Clin Gastroenterol Hepatol
(2010) - et al.
Effect of amitriptyline on symptoms, sleep, and visceral perception in patients with functional dyspepsia
Am J Gastroenterol
(1998) - et al.
Effect of the antidepressant venlafaxine in functional dyspepsia: a randomized, double-blind, placebo-controlled trial
Clin Gastroenterol Hepatol
(2008) - et al.
Functional Dyspepsia Treatment Trial (FDTT): a double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics
Contemp Clin Trials
(2012) - et al.
Outcome measures in irritable bowel syndrome: comparison of psychometric and methodological characteristics
Am J Gastroenterol
(2003) - et al.
Impaired drinking capacity in patients with functional dyspepsia: relationship with proximal stomach function
Gastroenterology
(2001) How many stratification factors are “too many” to use in a randomization plan?
Control Clin Trials
(1993)
Functional dyspepsia—symptoms, definitions and validity of the Rome III criteria
Nat Rev Gastroenterol Hepatol
Impaired gastric accommodation and its role in dyspepsia
Gut
Functional dyspepsia: the economic impact to patients
Aliment Pharmacol Ther
Review article: current treatment options and management of functional dyspepsia
Aliment Pharmacol Ther
Efficacy of antidepressants and psychological therapies in irritable bowel syndrome: systematic review and meta-analysis
Gut
New strategy of therapy for functional dyspepsia using famotidine, mosapride and amitriptyline
Aliment Pharmacol Ther
Treatment of functional dyspepsia with sertraline: a double-blind randomized placebo-controlled pilot study
World J Gastroenterol
Antidepressants as analgesics: a review of randomized controlled trials
J Psychiatry Neurosci
Antidepressants for functional gastrointestinal syndromes
Dig Dis Sci
Antidepressant therapy in 138 patients with irritable bowel syndrome: a five-year clinical experience
Aliment Pharmacol Ther
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Conflicts of interest These authors disclose the following: Nicholas J. Talley: Research support: National Health and Medical Research Council, Australia; National Institutes of Health; Abbott, Forest, Ironwood, Janssen, Pfizer, Prometheus, Rome Foundation. G. Richard Locke, III: Research support: Ironwood. Yuri A. Saito: Research support: Pfizer, Ironwood. Scientific Advisory Board: Salix. Colin W. Howdin: Consultant for Takeda, Otsuka, Forest, Ironwood and Salix. Speaking honoraria from Otsuka, Takeda, Forest, Ironwood and GlaxoSmithKline International. Brian E. Lacy: Scientific Advisory Board for Takeda, Ironwood, and Prometheus. Bincy P. Abraham: Research support: UCB. Consultant: Prometheus. Scientific Advisory Board for Janssen, Abbvie, UCB, Shire. Speaker: Janssen, Abbvie, UCB, Prometheus, Santaurus. Paul Moayyedi: Speakers honoraria: Shire, Forest and AstraZeneca. Chair partly funded by an unrestricted donation to McMaster University from AstraZeneca. Linda M. Herrick: Research support: Ironwood. The remaining authors disclose no conflicts.
Funding This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (DK065713). Forest Pharmaceuticals provided the escitalopram and identical placebo for the study.
Author names in bold designate shared co-first authorship.