Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan. Issue 7 (20th August 2013)

• Record Type: Journal Article
• Authors: Iwakiri, R.; Tominaga, K.; Furuta, K.; Inamori, M.; Furuta, T.; Masuyama, H.; Kanke, K.; Nagahara, A.; Haruma, K.; Kinoshita, Y.; Higuchi, K.; Takahashi, S.; Kusano, M.; Iwakiri, K.; Kato, M.; Hongo, M.; Hiraishi, H.; Watanabe, S.; Miwa, H.; Naito, Y.; Fujimoto, K.; Arakawa, T.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 38:Issue 7(2013)
• Page Start: 729
• Page End: 740
• Publication Date: 2013-08-20
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.12444
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt12444-abs-0001"> <title>Summary</title> <sec id="apt12444-sec-0001" sec-type="section"> <title>Background</title> <p>The efficacy of proton pump inhibitors (PPIs) for treating functional dyspepsia (FD) is not well established.</p> </sec> <sec id="apt12444-sec-0002" sec-type="section"> <title>Aim</title> <p>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.</p> </sec> <sec id="apt12444-sec-0003" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="apt12444-sec-0004" sec-type="section"> <title>Results</title> <p>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%, <italic>P </italic>=<italic> </italic>0.027) and the symptom diary assessment (48.7% vs. 30.0%, <italic>P </italic>=<italic> </italic>0.016). The efficacy was not influenced by syndrome type or <italic>Helicobacter pylori</italic> status. No statistically significant differences in the incidence of adverse events were seen among treatment groups.</p> </sec> <sec id="apt12444-sec-0005" sec-type="section"> <title>Conclusions</title> <p>Rabeprazole 20 mg once daily but not 10 or 40 mg significantly provides satisfactory symptom relief for functional dyspepsia (ClinicalTrials.gov, Number NCT01089543).</p> </sec> </abstract>