Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 149; no. 2; pp. 340 - 349.e2
• Main Authors: Talley, Nicholas J., Locke, G. Richard, Saito, Yuri A., Almazar, Ann E., Bouras, Ernest P., Howden, Colin W., Lacy, Brian E., DiBaise, John K., Prather, Charlene M., Abraham, Bincy P., El-Serag, Hashem B., Moayyedi, Paul, Herrick, Linda M., Szarka, Lawrence A., Camilleri, Michael, Hamilton, Frank A., Schleck, Cathy D., Tilkes, Katherine E., Zinsmeister, Alan R.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2015
• Subjects: Abdominal Pain; Adult; Amitriptyline - administration & dosage; Amitriptyline - therapeutic use; Antidepressant; Antidepressive Agents, Tricyclic - therapeutic use; Citalopram - administration & dosage; Citalopram - therapeutic use; Double-Blind Method; Drinking - drug effects; Dyspepsia - drug therapy; Dyspepsia - physiopathology; Dyspepsia - psychology; Female; Functional Dyspepsia; Functional Gastrointestinal Disorder; Gastric Emptying - drug effects; Gastroenterology and Hepatology; Humans; Male; Middle Aged; Quality of Life; Satiation - drug effects; Serotonin Uptake Inhibitors - therapeutic use; Time Factors; Treatment Outcome; Functional Dyspepsia; Antidepressant; Functional Gastrointestinal Disorder; EGD; OR; SSRIs; CI; TCAs; Abdominal Pain; MTV; NDI; IBS; FD; GE; irritable bowel syndrome; Nepean Dyspepsia Index; esophagogastroduodenoscopy; odds ratio; gastric emptying; serotonin reuptake inhibitors; confidence interval; maximum tolerated volume; tricyclic antidepressants
• ISSN: 0016-5085; 1528-0012; 1528-0012
• DOI: 10.1053/j.gastro.2015.04.020

Antidepressants 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. We 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. An 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. Amitriptyline, 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.