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Puasripun S, Thinrungroj N, Pinyopornpanish K, et al. Efficacy and Safety of Clidinium/Chlordiazepoxide as an Add-on Therapy in Functional Dyspepsia: A Randomized, Controlled, Trial. J Neurogastroenterol Motil. 2020;26(2):259-266doi: 10.5056/jnm19186.
Puasripun, S., Thinrungroj, N., Pinyopornpanish, K., Kijdamrongthum, P., Leerapun, A., Chitapanarux, T., Thongsawat, S., & Praisontarangkul, O. A. (2020). Efficacy and Safety of Clidinium/Chlordiazepoxide as an Add-on Therapy in Functional Dyspepsia: A Randomized, Controlled, Trial. Journal of neurogastroenterology and motility, 26(2), 259-266. https://doi.org/10.5056/jnm19186
Puasripun, Siripa, et al. "Efficacy and Safety of Clidinium/Chlordiazepoxide as an Add-on Therapy in Functional Dyspepsia: A Randomized, Controlled, Trial." Journal of neurogastroenterology and motility vol. 26,2 (2020): 259-266. doi: https://doi.org/10.5056/jnm19186
Puasripun S, Thinrungroj N, Pinyopornpanish K, Kijdamrongthum P, Leerapun A, Chitapanarux T, Thongsawat S, Praisontarangkul OA. Efficacy and Safety of Clidinium/Chlordiazepoxide as an Add-on Therapy in Functional Dyspepsia: A Randomized, Controlled, Trial. J Neurogastroenterol Motil. 2020 Apr 30;26(2):259-266. doi: 10.5056/jnm19186. PMID: 32235033; PMCID: PMC7176503.
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J Neurogastroenterol Motil. 2020 Apr 30;26(2):259-266. doi: 10.5056/jnm19186.

Efficacy and Safety of Clidinium/Chlordiazepoxide as an Add-on Therapy in Functional Dyspepsia: A Randomized, Controlled, Trial.

Journal of neurogastroenterology and motility

Siripa Puasripun, Nithi Thinrungroj, Kanokwan Pinyopornpanish, Phuripong Kijdamrongthum, Apinya Leerapun, Taned Chitapanarux, Satawat Thongsawat, Ong-Ard Praisontarangkul

Affiliations

  1. Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

PMID: 32235033 PMCID: PMC7176503 DOI: 10.5056/jnm19186

Abstract

BACKGROUND/AIMS: The treatment of refractory functional dyspepsia (FD) is a challenge. Clidinium/chlordiazepoxide is a combination of antispasmodic and anxiolytic drugs that has been used as an adjunct treatment for FD in clinical practice with limited supporting evidence of efficacy. The aim of the study is to assess the efficacy and safety of clidinium/chlordiazepoxide as an adjunct treatment to a proton pump inhibitor (PPI) in refractory dyspepsia.

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 (

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.

Keywords: Anti-anxiety agents; Antispasmodic agents; Chlordiazepoxide; Dyspepsia; Humans; clidinium drug combination

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