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

Hidekazu Suzuki, Hiroaki Kusunoki, Takeshi Kamiya, Seiji Futagami, Yasuharu Yamaguchi, Toshihiro Nishizawa, Eisuke Iwasaki, Juntaro Matsuzaki, Shinichi Takahashi, Choitsu Sakamoto, Ken Haruma, Takashi Joh, Keiko Asakura, Toshifumi Hibi

Research output: Contribution to journalArticle

20 Citations (Scopus)

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 doubleblind 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.

Original languageEnglish
Pages (from-to)445-452
Number of pages8
JournalUnited European Gastroenterology Journal
Volume1
Issue number6
DOIs
Publication statusPublished - 2013

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Lansoprazole
Dyspepsia
Controlled Clinical Trials
Multicenter Studies
Placebos
Satiation
Pain
Proton Pump Inhibitors
Publications
Japan

Keywords

  • Functional dyspepsia
  • Lansoprazole
  • Proton pump inhibitor
  • Rome III

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

Cite this

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

In: United European Gastroenterology Journal, Vol. 1, No. 6, 2013, p. 445-452.

Research output: Contribution to journalArticle

Suzuki, H, Kusunoki, H, Kamiya, T, Futagami, S, Yamaguchi, Y, Nishizawa, T, Iwasaki, E, Matsuzaki, J, Takahashi, S, Sakamoto, C, Haruma, K, Joh, T, Asakura, K & Hibi, T 2013, 'Effect of lansoprazole on the Epigastric symptoms of functional dyspepsia (Elf study): A multicentre, prospective, randomized, double-blind, placebo-controlled clinical trial', United European Gastroenterology Journal, vol. 1, no. 6, pp. 445-452. https://doi.org/10.1177/2050640613510904
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. / Effect of lansoprazole on the Epigastric symptoms of functional dyspepsia (Elf study) : A multicentre, prospective, randomized, double-blind, placebo-controlled clinical trial. In: United European Gastroenterology Journal. 2013 ; Vol. 1, No. 6. pp. 445-452.
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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 doubleblind 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.",
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AU - Suzuki, Hidekazu

AU - Kusunoki, Hiroaki

AU - Kamiya, Takeshi

AU - Futagami, Seiji

AU - Yamaguchi, Yasuharu

AU - Nishizawa, Toshihiro

AU - Iwasaki, Eisuke

AU - Matsuzaki, Juntaro

AU - Takahashi, Shinichi

AU - Sakamoto, Choitsu

AU - Haruma, Ken

AU - Joh, Takashi

AU - Asakura, Keiko

AU - Hibi, Toshifumi

PY - 2013

Y1 - 2013

N2 - 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 doubleblind 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.

AB - 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 doubleblind 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.

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