Treatment of functional dyspepsia with serotonin agonists: A meta-analysis of randomized controlled trials

Background: Functional dyspepsia (FD) is often treated with serotonin agonists; however, the efficacy of such agents has recently been questioned. The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) comparing serotonin agonists with other types of prokinetics in patients with FD. Methods: Included studies were RCTs that compared serotonin agonists, including cisapride and mosapride, with dopamine antagonists, including metoclopramide and domperidone, and an opiate agonist, trimebutine, in patients with FD. Studies were identified by searching the Medline database (January 1951 - January 2005) and Cochrane Library (Issue 4, 2004), and by manual searches. The difference in the probability of patients' responses between the serotonin agonists and control agents was used as a summary statistic for the treatment effect. Meta-regression analysis was used to detect sources of heterogeneity. Results: Five studies were identified. In total, 467 subjects were assigned to a serotonin agonist arm, and 322 subjects were assigned to a control arm. In the overall analysis, the summary statistic was 0.019 (95% confidence interval [CI]: -0.055 to 0.093; P = 0.612), indicating that the patients' responses to serotonin agonists were similar to those to control agents. However, in the stratified meta-analysis of cisapride and mosapride, mosapride had a 6.7% greater probability of producing a response compared with control agents (summary statistic: 0.067; 95% CI: 0.010-0.124; P = 0.021), whereas no significant effect was observed with cisapride. Conclusion: The data suggest that mosapride may be more effective than cisapride for the treatment of FD. Although FD is a chronic condition, efficacy was assessed over short periods in the studies used for the present meta-analysis. Long-term RCTs are needed to confirm the effect.