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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
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.
Nicholas J
NJ
Talley
Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
G Richard
GR
Locke
Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Yuri A
YA
Saito
Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Ann E
AE
Almazar
Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida.
Ernest P
EP
Bouras
Gastroenterology, Northwestern University, Chicago, Illinois.
Colin W
CW
Howden
Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Brian E
BE
Lacy
Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona.
John K
JK
DiBaise
Gastroenterology, St Louis University, St Louis, Missouri.
Charlene M
CM
Prather
Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas.
Bincy P
BP
Abraham
Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas.
Hashem B
HB
El-Serag
Gastroenterology, McMaster University, Hamilton, Ontario, Canada.
Paul
P
Moayyedi
Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Linda M
LM
Herrick
Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Lawrence A
LA
Szarka
Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Michael
M
Camilleri
Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.
Frank A
FA
Hamilton
Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.
Cathy D
CD
Schleck
Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Katherine E
KE
Tilkes
Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.
Alan R
AR
Zinsmeister
D000328:Adult; D000639:Amitriptyline / Q000008:administration & dosage / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use*; D015283:Citalopram / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004326:Drinking / Q000187:drug effects; D004415:Dyspepsia / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D005260:Female; D005746:Gastric Emptying / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012527:Satiation / Q000187:drug effects; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D000639:Amitriptyline; D000929:Antidepressive Agents, Tricyclic; D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors
Abdominal Pain; Antidepressant; Functional Dyspepsia; Functional Gastrointestinal Disorder