Effect of lansoprazole on the epigastric symptoms of functional dyspepsia (ELF study): A multicentre, prospective, randomized, double-blind, placebo-controlled clinical trial

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...

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Published in:United European gastroenterology journal 2013-12, Vol.1 (6), p.445-452
Main Authors: 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
Format: Article
Language:English
Subjects:
Functional dyspepsia
lansoprazole
Original
proton pump inhibitor
Rome III
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Summary: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.
ISSN:2050-6406
2050-6414
DOI:10.1177/2050640613510904