Efficacy of rabeprazole on functional dyspepsia in a multicenter clinical trial.

Background: Patients with functional dyspepsia (FD) are often treated with proton pump inhibitors (PPIs), but the efficacy of PPIs for treating FD is not well established.
Objectives: This study aimed to assess the efficacy of rabeprazole in Japanese patients with FD in a multicentre, double-blinded, randomised, placebo-controlled trial.
Methods: All the 338 patients with FD diagnosed using the Rome III criteria were randomly assigned to 8 weeks of double-blind treatment with rabeprazole 10 mg, 20 mg, 40 mg or placebo. Dyspeptic symptoms were assessed by a dyspepsia symptom questionnaire and symptom diary.
Results: Although there was no significant difference between placebo and rabeprazole groups in complete symptom relief for four major dyspeptic symptoms, the satisfactory symptom relief of rabeprazole 20 mg was significantly higher than placebo according to the dyspepsia symptom questionnaire (45.3% vs. 28.2%, P = 0.027) and the symptom diary assessment (48.7% vs. 30.0%, P = 0.016). Syndrome type, Helicobacter pylori status or CYP2C19 genetic polymorphisms did not influence the efficacy of PPI treatment.
Conclusions: Rabeprazole 20 mg once daily but not 10 or 40 mg significantly provides satisfactory symptom relief for functional dyspepsia.