Holtmann G et al. (2006) A placebocontrolled trial of itopride in functional dyspepsia. N Engl J Med 354: 832–840

Functional dyspepsia is a common problem, characterized by symptoms of upper abdominal pain and discomfort, which are thought to arise from disturbances in gastrointestinal motility and sensory function. Itopride, a dopamine D2 receptor antagonist, is frequently used to treat patients with functional dyspepsia in Japan; however, large trials of its efficacy and dose response are lacking.

Holtmann and colleagues carried out a multicenter, randomized trial of itopride in a population of patients with functional dyspepsia in Germany. In total, 554 patients were randomly assigned to receive itopride at a dose of 50 mg, 100 mg, or 200 mg, or placebo, three times daily for 8 weeks, after which they were assessed in terms of symptom improvement.

Data were available for 523 participants, and showed that itopride was more effective in improving the symptoms of functional dyspepsia than placebo, and that the improvement seen with each of the three different doses of itopride was approximately 50% greater than that seen with placebo. In addition, no marked difference was observed in the rate of adverse events between the treatment and placebo groups.

The results of this trial suggest that itopride is superior to placebo in treating patients with functional dyspepsia; however, the mechanism by which the drug exerts its effects remains unknown. The authors highlight the need for further trials of itopride in this context that focus on the duration of treatment and its efficacy in different populations.