Open AccessEffect of lansoprazole on the epigastric symptoms of functional dyspepsia (ELF study): A multicentre, prospective, randomized, double‐blind, placebo‐controlled clinical trial
Author(s) -
Suzuki Hidekazu,
Kusunoki Hiroaki,
Kamiya Takeshi,
Futagami Seiji,
Yamaguchi Yasuharu,
Nishizawa Toshihiro,
Iwasaki Eisuke,
Matsuzaki Juntaro,
Takahashi Shinichi,
Sakamoto Choitsu,
Haruma Ken,
Joh Takashi,
Asakura Keiko,
Hibi Toshifumi
Publication year - 2013
Publication title -
ueg journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.667
H-Index - 35
eISSN - 2050-6414
pISSN - 2050-6406
DOI - 10.1177/2050640613510904
Subject(s) - medicine , lansoprazole , placebo , double blind , gastroenterology , randomized controlled trial , epigastric pain , clinical trial , omeprazole , pathology , alternative medicine , vomiting
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.