Efficacy of buspirone, a fundus-relaxing drug, in patients with functional dyspepsia

Clin Gastroenterol Hepatol. 2012 Nov;10(11):1239-45. doi: 10.1016/j.cgh.2012.06.036. Epub 2012 Jul 17.


Background & aims: Impaired accommodation and hypersensitivity to gastric distention are believed to be involved in the development of functional dyspepsia (FD). Buspirone, a 5-hydroxytryptamine 1A receptor agonist, relaxes the proximal stomach in healthy individuals. We studied the effects of buspirone on symptoms and mechanisms of FD.

Methods: We performed a randomized, double-blind, placebo-controlled, crossover study of 17 patients (13 women; mean age, 38.5 ± 2.4 years). The study included 2 treatment periods of 4 weeks each, separated by a 2-week washout period. In the first period, 7 participants were given buspirone (10 mg, 3 times daily for 4 weeks) and 10 were given placebo 15 minutes before meals; patients switched groups for the second period. We assessed meal-related symptoms and severity, along with gastric sensitivity, accommodation, and emptying (by using barostat and breath tests) before and after 4 weeks of treatment.

Results: Buspirone significantly reduced the overall severity of symptoms of dyspepsia (7.5 ± 1.3 vs 11.5 ± 1.2 for placebo; P < .005) and individual symptoms of postprandial fullness, early satiation, and upper abdominal bloating, whereas placebo had no significant effect (all P < .05). Buspirone did not alter the rate of gastric emptying of solids or sensitivity to gastric distention, but it significantly increased gastric accommodation, compared with placebo (229 ± 28 vs 141 ± 32 mL, respectively; P < .05), and delayed gastric emptying of liquids (half-life = 64 ± 5 vs 119 ± 24 minutes, respectively). Adverse events were similar when patients were given buspirone or placebo.

Conclusions: In patients with FD, 4 weeks of administration of buspirone significantly improved symptoms and gastric accommodation, compared with placebo, whereas gastric emptying of liquids was delayed.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Buspirone / administration & dosage*
  • Cross-Over Studies
  • Double-Blind Method
  • Dyspepsia / drug therapy*
  • Dyspepsia / pathology
  • Dyspepsia / physiopathology
  • Female
  • Gastric Emptying / drug effects
  • Gastrointestinal Agents / administration & dosage*
  • Humans
  • Male
  • Middle Aged
  • Placebos / administration & dosage
  • Treatment Outcome


  • Gastrointestinal Agents
  • Placebos
  • Buspirone