Effect of amitriptyline and escitalopram on functional dyspepsia

A multicenter, randomized controlled study

Nicholas J. Talley, G. Richard Locke, Yuri A. Saito, Ann E. Almazar, Ernest P. Bouras, Colin Howden, Brian E. Lacy, John K. Dibaise, Charlene M. Prather, Bincy P. Abraham, Hashem B. El-Serag, Paul Moayyedi, Linda M. Herrick, Lawrence A. Szarka, Michael Camilleri, Frank A. Hamilton, Cathy D. Schleck, Katherine E. Tilkes, Alan R. Zinsmeister

Research output: Contribution to journalArticle

96 Citations (Scopus)

Abstract

Background & Aims 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.

Original languageEnglish (US)
Pages (from-to)340-349.e2
JournalGastroenterology
Volume149
Issue number2
DOIs
StatePublished - Aug 1 2015

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Citalopram
Amitriptyline
Dyspepsia
Gastric Emptying
Antidepressive Agents
Placebos
Ulcer
Meals
Odds Ratio
Quality of Life
Confidence Intervals
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

Talley, N. J., Richard Locke, G., Saito, Y. A., Almazar, A. E., Bouras, E. P., Howden, C., ... Zinsmeister, A. R. (2015). Effect of amitriptyline and escitalopram on functional dyspepsia: A multicenter, randomized controlled study. Gastroenterology, 149(2), 340-349.e2. https://doi.org/10.1053/j.gastro.2015.04.020

Effect of amitriptyline and escitalopram on functional dyspepsia : A multicenter, randomized controlled study. / Talley, Nicholas J.; Richard Locke, G.; Saito, Yuri A.; Almazar, Ann E.; Bouras, Ernest P.; Howden, Colin; 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.

In: Gastroenterology, Vol. 149, No. 2, 01.08.2015, p. 340-349.e2.

Research output: Contribution to journalArticle

Talley, NJ, Richard Locke, G, Saito, YA, Almazar, AE, Bouras, EP, Howden, C, Lacy, BE, Dibaise, JK, Prather, CM, Abraham, BP, El-Serag, HB, Moayyedi, P, Herrick, LM, Szarka, LA, Camilleri, M, Hamilton, FA, Schleck, CD, Tilkes, KE & Zinsmeister, AR 2015, 'Effect of amitriptyline and escitalopram on functional dyspepsia: A multicenter, randomized controlled study', Gastroenterology, vol. 149, no. 2, pp. 340-349.e2. https://doi.org/10.1053/j.gastro.2015.04.020
Talley, Nicholas J. ; Richard Locke, G. ; Saito, Yuri A. ; Almazar, Ann E. ; Bouras, Ernest P. ; Howden, Colin ; 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. / Effect of amitriptyline and escitalopram on functional dyspepsia : A multicenter, randomized controlled study. In: Gastroenterology. 2015 ; Vol. 149, No. 2. pp. 340-349.e2.
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author = "Talley, {Nicholas J.} and {Richard Locke}, G. and Saito, {Yuri A.} and Almazar, {Ann E.} and Bouras, {Ernest P.} and Colin Howden and Lacy, {Brian E.} and Dibaise, {John K.} and Prather, {Charlene M.} and Abraham, {Bincy P.} and El-Serag, {Hashem B.} and Paul Moayyedi and Herrick, {Linda M.} and Szarka, {Lawrence A.} and Michael Camilleri and Hamilton, {Frank A.} and Schleck, {Cathy D.} and Tilkes, {Katherine E.} and Zinsmeister, {Alan R.}",
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T2 - A multicenter, randomized controlled study

AU - Talley, Nicholas J.

AU - Richard Locke, G.

AU - Saito, Yuri A.

AU - Almazar, Ann E.

AU - Bouras, Ernest P.

AU - Howden, Colin

AU - Lacy, Brian E.

AU - Dibaise, John K.

AU - Prather, Charlene M.

AU - Abraham, Bincy P.

AU - El-Serag, Hashem B.

AU - Moayyedi, Paul

AU - Herrick, Linda M.

AU - Szarka, Lawrence A.

AU - Camilleri, Michael

AU - Hamilton, Frank A.

AU - Schleck, Cathy D.

AU - Tilkes, Katherine E.

AU - Zinsmeister, Alan R.

PY - 2015/8/1

Y1 - 2015/8/1

N2 - Background & Aims 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.

AB - Background & Aims 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.

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