Hidekazu Suzuki1, Hiroaki Kusunoki2, Takeshi Kamiya3, Seiji Futagami4, Yasuharu Yamaguchi5, Toshihiro Nishizawa6, Eisuke Iwasaki7, Juntaro Matsuzaki8, Shinichi Takahashi5, Choitsu Sakamoto4, Ken Haruma2, Takashi Joh3, Keiko Asakura9, Toshifumi Hibi1. 1. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. 2. Division of Gastroenterology, Department of Internal Medicine, Kawasaki Medical University, Okayama, Japan. 3. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan. 4. Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan. 5. The Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo, Japan. 6. Division of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan. 7. Department of Internal Medicine, Tokyo Saiseikai Central Hospital, Tokyo, Japan. 8. 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. 9. Department of Social and Preventive Epidemiology, School of Public Health, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
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.
RCT Entities:
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 FDparticipants 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.
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