Antidepressant appears to relieve functional dyspepsia symptoms
A multicenter, randomized controlled trial of antidepressants in patients with functional dyspepsia showed amitriptyline appeared to improve symptoms in some patients, while escitalopram did not.
“The functional dyspepsia treatment trial (FDTT) is important because it will change practice. Unlike [irritable bowel syndrome], patients with functional dyspepsia do not respond to a selective serotonin uptake inhibitor (SSRI),” Nicholas J. Talley, MD, PhD, from the Mayo Clinic in Rochester, Minn., and University of Newcastle in Australia, told Healio Gastroenterology. “There is a modest benefit of a tricyclic most notably for epigastric (ulcer-like) pain. Another notable finding was the lack of efficacy in those with delayed gastric emptying suggesting different disease mechanisms may be in play in those with versus without slow emptying. A tricyclic is unlikely to benefit those with gastroparesis.”
Nicholas J. Talley
Aiming to determine the effects of antidepressants on functional dyspepsia (FD) symptoms, gastric emptying and meal-induced satiety, Talley and colleagues randomly assigned 292 patients (mean age, 44 ± 15 years; 75% women; 86% Caucasian) with FD (70% with dysmotility-like FD; 30% with ulcer-like FD) from eight sites in North America to receive placebo, 50-mg amitriptyline or 10-mg escitalopram for 10 weeks after a 2- to 4-week washout period. Adequate relief of dyspepsia symptoms and quality of life were evaluated by weekly questionnaires, gastric emptying was evaluated by scintigraphy at baseline and end of treatment, and meal-induced satiety was evaluated with a nutrient drink test. Patients were followed-up monthly for 6 months.
Overall, 40% of the placebo group reported adequate symptom relief compared with 53% of the amitriptyline group and 38% of the escitalopram group (P = .05). Patients who received amitriptyline appeared to have superior response compared with placebo (OR = 1.1; 95% CI, 0.6-2.1).
Patients with ulcer-like FD who received amitriptyline were three times as likely to report adequate symptom relief compared with those who received placebo (OR = 3.1; 95% CI, 1.1-9). Neither antidepressant tested appeared to affect gastric emptying or meal-induced satiety after 10 weeks, but both improved overall quality of life compared with placebo (P = .02). Patients with delayed gastric emptying at baseline were less likely to report adequate symptom relief compared to those with normal gastric emptying (OR = 0.4; 95% CI, 0.2-0.8). Among responders who completed 6-month follow-up, 73% relapsed off therapy. Adverse events were reported in 21% of the placebo group, 30% of the amitriptyline group and 29% of the escitalopram group (P > .05), and no serious adverse events were reported.
The researchers concluded that “amitriptyline appeared beneficial in FD, particularly in those with ulcer-like FD. Although adverse events were common, there was no overall difference between the three arms (except in neurologic symptoms, with highest rates in the escitalopram arm) suggesting that with provider counseling and support, [tricyclic antidepressants] will be generally well tolerated at low doses. The results do not support the use of escitalopram in FD.”
In an accompanying editorial, William L. Hasler, MD, from University of Michigan Health System, and Kenneth L. Koch, MD, from Wake Forest University, described these findings as “the most comprehensive characterization of antidepressant responses in [FD] to date.”
The study showed “modest efficacy of a tricyclic agent, but not a selective serotonin reuptake inhibitor” in reducing FD symptoms, primarily in a small subgroup of patients with ulcer-like pain, they added.
“The lack of efficacy in patients with dyspepsia with delayed gastric emptying suggests the possible utility of scintigraphic testing to select patients with normal rather than abnormal emptying profiles for amitriptyline therapy. Given the difficulties in conducting trials with this drug class, this careful investigation may represent the definitive description of the utility of tricyclic antidepressants for [FD],” they concluded. – by Adam Leitenberger
Disclosure: Talley reports he received research support from the National Health and Medical Research Council, Australia, the National Institutes of Health, Abbott, Forest, Ironwood, Janssen, Pfizer, Prometheus and the Rome Foundation. Please see the study for a list of all other researchers’ relevant financial disclosures. Hasler and Koch report no relevant financial disclosures.