title: Effect of lansoprazole on the epigastric symptoms of functional dyspepsia (ELF study): A multicentre, prospective, randomized, double-blind, placebo-controlled clinical trial.
abstract: BACKGROUND
  Since the publication of the Rome III criteria for functional dyspepsia (FD), the evidence about the efficacy of half-dose of proton pump inhibitors for dyspepsia symptoms have been limited.
  
  
  OBJECTIVE
  To examine the efficacy of lansoprazole for functional dyspepsia (FD) diagnosed with the Rome III criteria by the multicentre, double-blind, randomized, placebo-controlled study in Japan.
  
  
  METHODS
  A total of 54 FD participants were randomized to lansoprazole 15 mg once daily or placebo for a 4-week double-blind treatment period. The primary efficacy endpoint was an overall dyspeptic symptom relief rate evaluated by 5-point Likert scale scores. The alteration of dyspeptic symptom scores during the study period was also assessed.
  
  
  RESULTS
  At week 4, the overall dyspeptic symptom relief rates were higher in the lansoprazole group (30.4%) than in the placebo group (6.7%) (p = 0.045). The scores for epigastric pain (p = 0.045) and epigastric burning (p = 0.03) were significantly improved in the lansoprazole group compared to the placebo group, whereas the improvement of the scores for postprandial fullness (p = 0.81) and early satiation (p = 0.33) was not different between lansoprazole and placebo groups.
  
  
  CONCLUSIONS
  Lansoprazole 15 mg ameliorates dyspeptic symptoms, particularly the epigastric pain syndrome-related symptoms of FD.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Hidekazu
authors.initials: H
authors.lastname: Suzuki
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kawasaki Medical University, Okayama, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Kusunoki
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kamiya
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Futagami
authors.affiliation: The Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo, Japan.
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Yamaguchi
authors.affiliation: Division of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nishizawa
authors.affiliation: Department of Internal Medicine, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
authors.forename: Eisuke
authors.initials: E
authors.lastname: Iwasaki
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan ; Department of Internal Medicine, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
authors.forename: Juntaro
authors.initials: J
authors.lastname: Matsuzaki
authors.affiliation: The Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Takahashi
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
authors.forename: Choitsu
authors.initials: C
authors.lastname: Sakamoto
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kawasaki Medical University, Okayama, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Haruma
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Joh
authors.affiliation: Department of Social and Preventive Epidemiology, School of Public Health, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
authors.forename: Keiko
authors.initials: K
authors.lastname: Asakura
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
keywords: Functional dyspepsia; Rome III; lansoprazole; proton pump inhibitor