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Clinical Trial: Efficacy of Mosapride Controlled-release and Nortriptyline in Patients With Functional Dyspepsia: A Multicenter, Double-placebo, Double-blinded, Randomized Controlled, Parallel Clinical Study

Authors
 Chung Hyun Tae  ;  Ra Ri Cha  ;  Jung-Hwan Oh  ;  Tae-Guen Gweon  ;  Jong Kyu Park  ;  Ki Bae Bang  ;  Kyung Ho Song  ;  Cheal Wung Huh  ;  Ju Yup Lee  ;  Cheol Min Shin  ;  Jong Wook Kim  ;  Young Hoon Youn  ;  Joong Goo Kwon 
Citation
 JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY, Vol.30(1) : 106-115, 2024-01 
Journal Title
JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY
ISSN
 2093-0879 
Issue Date
2024-01
Keywords
Depression ; Dyspepsia ; Mosapride ; Nortriptyline ; Prokinetics
Abstract
Background/Aims Prokinetic agents and neuromodulators are among the treatment options for functional dyspepsia (FD), but their comparative efficacy is unclear. We aimed to compare the efficacy of mosapride controlled-release (CR) and nortriptyline in patients with FD after 4 weeks of treatment. Methods Participants with FD were randomly assigned (1:1) to receive mosapride CR (mosapride CR 15 mg and nortriptyline placebo) or nortriptyline (mosapride CR placebo and nortriptyline 10 mg) in double-placebo, double-blinded, randomized controlled, parallel clinical study. The primary endpoint was defined as the proportion of patients with overall dyspepsia improvement after 4 weeks treatment. The secondary endpoints were changes in individual symptom scores, anxiety, depression, and quality of life. Results One hundred nine participants were recruited and assessed for eligibility, and 54 in the mosapride CR group and 50 in the nortriptyline group were included in the modified intention-to-treat protocol. The rate of overall dyspepsia improvement was similar between groups (53.7% vs 54.0%, P = 0.976). There was no difference in the efficacy of mosapride CR and nortriptyline in a subgroup analysis by FD subtype (59.3% vs 52.5% in postprandial distress syndrome, P = 0.615; 44.4% vs 40.0% in epigastric pain syndrome, P = > 0.999; 50.0% vs 59.1% in overlap, P = 0.565; respectively). Both treatments significantly improved anxiety, depression, and quality of life from baseline. Conclusion Mosapride CR and nortriptyline showed similar efficacy in patients with FD regardless of the subtype. Both treatments could be equally helpful for improving quality of life and psychological well-being while also relieving dyspepsia.
Files in This Item:
T202402992.pdf Download
DOI
10.5056/jnm23147
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Youn, Young Hoon(윤영훈) ORCID logo https://orcid.org/0000-0002-0071-229X
Huh, Cheal Wung(허철웅)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/199261
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