Amitriptyline may relieve functional dyspepsia symptoms

ORLANDO, Fla. — Patients with functional dyspepsia were more likely to experience relief when treated with amitriptyline than placebo or escitalopram in a study presented at Digestive Disease Week.

In a prospective, double blind multicenter trial, researchers randomly assigned 292 adults with functional dyspepsia (FD) to placebo or antidepressant therapy with either 50 mg amitriptyline or 10 mg escitalopram (1:1:1) daily for 12 weeks. Gastric emptying and satiety tests also were performed at baseline and at 12 weeks. All participants had normal results from an upper endoscopy conducted within the prior 5 years, and were not on antidepressant therapy at enrollment. Amitriptyline recipients initially received 25-mg doses for 2 weeks before dose escalation to 50 mg.

Response to treatment was defined as adequate FD relief reported on 50% or more of treatment weeks 3 through 12. Up to 36 weeks of post-treatment follow-up data was being collected upon presentation of the results of intent-to-treat analysis at the meeting.

Response occurred in 53% of amitriptyline recipients, compared with 40% of placebo recipients and 38% of escitalopram recipients (P=.05 after adjustment for confounders). Patients with ulcer-like FD trended toward better response than those with dysmotility-like dyspepsia (n=204) (P=.06). No significant difference in response was observed according to BMI or sex, although investigators said men had numerically better response rates than women.

Across all treatments, patients with normal gastric emptying were significantly more likely to experience response compared with those with delayed gastric emptying (n=61) (P=.006). Response did not differ significantly according to satiety test results.

“We believe, based on these results, that amitriptyline appears to be an efficacious treatment for FD,” researcher Nicholas J. Talley, MD, PhD, department of gastroenterology and hepatology at Mayo Clinic in Rochester, Minn., said. “Escitalopram, however, very clearly was not efficacious and was no better than placebo in FD. We showed the treatment effect may be greater in ulcer-like FD and in males ... [and] overall response to treatment was predicted by gastric emptying status. If you have delayed gastric emptying, it looks to us as if amitriptyline shouldn’t be used.”

Disclosure: The researchers report numerous financial disclosures.

For more information:

Locke GR. #810: The Functional Dyspepsia Treatment Trial (Fdtt) Key Results. Presented at: Digestive Disease Week 2013; May 18-21, Orlando, Fla.