Abstract | BACKGROUND/AIMS: METHODS: We performed a study of patients who met the Rome IV criteria for FD who failed to respond to PPIs. Patients were randomly assigned to groups that received clidinium/ chlordiazepoxide or placebo as an add-on treatment to PPI for 4 weeks. The primary outcome was the rate of responders, which was defined as a > 50% reduction in dyspepsia symptom score after 4 weeks of treatment. The secondary outcomes were an improvement in the quality of life and the safety profile. RESULTS: Between March 2017 and February 2018, 78 patients were enrolled. The rates of responders in the clidinium/ chlordiazepoxide group and placebo groups were 41.03 % and 5.13% at week 4 (P < 0.001). The clidinium/ chlordiazepoxide group also showed significant improvement in overall quality of life over placebo. However, the clidinium/ chlordiazepoxide group had more frequent drowsiness than the placebo group (30.27% vs 6.52%, P = 0.034). There were no major adverse events in either group. CONCLUSIONS:
Clidinium/ chlordiazepoxide significantly improved dyspeptic symptoms and quality of life. This combination may be used as an add-on therapy in FD patients without major adverse events.
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Authors | Siripa Puasripun, Nithi Thinrungroj, Kanokwan Pinyopornpanish, Phuripong Kijdamrongthum, Apinya Leerapun, Taned Chitapanarux, Satawat Thongsawat, Ong-Ard Praisontarangkul |
Journal | Journal of neurogastroenterology and motility
(J Neurogastroenterol Motil)
Vol. 26
Issue 2
Pg. 259-266
(Apr 30 2020)
ISSN: 2093-0879 [Print] Korea (South) |
PMID | 32235033
(Publication Type: Journal Article)
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