title: Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan.
abstract: BACKGROUND
  The efficacy of proton pump inhibitors (PPIs) for treating functional dyspepsia (FD) is not well established.
  
  
  OBJECTIVE
  This study, named the SAMURAI study, aimed to assess the efficacy and dose-response relationship of rabeprazole in Japanese patients with FD in a multicentre, double-blinded, randomised, placebo-controlled trial.
  
  
  METHODS
  Investigated FD was diagnosed using the Rome III criteria. Subjects who did not respond to 1 week of single-blind placebo treatment in a run-in period were randomly assigned to 8 weeks of double-blind treatment with rabeprazole 10 mg, 20 mg, 40 mg or placebo, once daily. Dyspeptic symptoms were assessed by a dyspepsia symptom questionnaire (7-point Likert scale) and symptom diary.
  
  
  RESULTS
  Of 392 subjects entered into the run-in period, 338 were randomly assigned. 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). The efficacy was not influenced by syndrome type or Helicobacter pylori status. No statistically significant differences in the incidence of adverse events were seen among treatment groups.
  
  
  CONCLUSIONS
  Rabeprazole 20 mg once daily but not 10 or 40 mg significantly provides satisfactory symptom relief for functional dyspepsia (ClinicalTrials.gov, Number NCT01089543).
authors: Department of Internal Medicine & Gastrointestinal Endoscopy, Saga Medical School, Saga, Japan. iwakiri@cc.saga-u.ac.jp
authors: R
authors: R
authors: Iwakiri
authors: K
authors: K
authors: Tominaga
authors: K
authors: K
authors: Furuta
authors: M
authors: M
authors: Inamori
authors: T
authors: T
authors: Furuta
authors: H
authors: H
authors: Masuyama
authors: K
authors: K
authors: Kanke
authors: A
authors: A
authors: Nagahara
authors: K
authors: K
authors: Haruma
authors: Y
authors: Y
authors: Kinoshita
authors: K
authors: K
authors: Higuchi
authors: S
authors: S
authors: Takahashi
authors: M
authors: M
authors: Kusano
authors: K
authors: K
authors: Iwakiri
authors: M
authors: M
authors: Kato
authors: M
authors: M
authors: Hongo
authors: H
authors: H
authors: Hiraishi
authors: S
authors: S
authors: Watanabe
authors: H
authors: H
authors: Miwa
authors: Y
authors: Y
authors: Naito
authors: K
authors: K
authors: Fujimoto
authors: T
authors: T
authors: Arakawa
mesh_terms: D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000302:isolation & purification; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D064750:Rabeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors; D064750:Rabeprazole