Efficacy of Buspirone, a Fundus-Relaxing Drug, in Patients With Functional Dyspepsia

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.