Efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study
Aim. Evaluation of the practice of using trimebutine (tablets, 300 mg, extended release), for the treatment of patients with functional gastrointestinal disorders (FGID) in primary health care. Materials and methods. A prospective observational multicenter non-interventional study was carried out...
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"Consilium Medicum" Publishing house
2021
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oai:doaj.org-article:31a3bd3ed87e4946bfb86be231e66c412021-12-01T12:22:36ZEfficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study0040-36602309-534210.26442/00403660.2021.08.200919https://doaj.org/article/31a3bd3ed87e4946bfb86be231e66c412021-08-01T00:00:00Zhttps://ter-arkhiv.ru/0040-3660/article/viewFile/79425/60070https://doaj.org/toc/0040-3660https://doaj.org/toc/2309-5342Aim. Evaluation of the practice of using trimebutine (tablets, 300 mg, extended release), for the treatment of patients with functional gastrointestinal disorders (FGID) in primary health care. Materials and methods. A prospective observational multicenter non-interventional study was carried out, which included patients of both sexes aged 18 to 60 years with a verified diagnosis of functional gastrointestinal disorders (functional dyspepsia, irritable bowel syndrome, biliary tract dysfunction, sphincter of Oddi dysfunction, postcholecystectomy syndrome). Trimebutine was prescribed in accordance with the instructions for medical use: orally, 300 mg twice per day for 28 days. The severity of simptoms was evaluated by five-point rating scale. Results. The study included 4433 patients, the per protocol sample consisted of 3831 people. The proportion of patients with a significant decrease in the severity of abdominal pain after treatment was 74.73% (95% confidence interval CI 73.3276.11). At the and of the study a statistically significant decrease in the severity of FGID` simptoms was observed: epigastric pain/burning (mean score at the 1st visit was 1.21 [95% CI 1.181.25], at the 2nd visit 0.22 [95% CI 0.20.23]; p0.001), abdominal pain (1st visit 2.01 [95% CI 1.982.04), 2nd visit 0.33 [95% CI 0.310.35]; p0.001), biliary pain (1st visit 1.22 [95% CI 1.181.26], 2nd visit 0.2 [95% CI 0.190.22]; p0.001), postprandial fullness and early satiation (1st visit 1.29 [95% CI 1.251.32], 2nd visit 0.21 [95% CI 0.190.22]; p0.001), severity of heartburn (1st visit 0.92 [95% CI 0.880.95], 2nd visit 0.18 [95% CI 0.170.20]; p0.001), belching (1st visit 1.13 [95% CI 1.091.16], 2nd visit 0.22 [95% CI 0.210.24]; p0.001), as well as abdominal distention (1st visit 1.99 (95% CI 1, 96, 2.03), 2nd visit 0.43 [95% CI 0.410.45]; p0.001). Conclusion. The present prospective observational multicenter non-interventional study has demonstrated that trimebutine is an effective approach to treating FGID.Dmitry N. AndreevIgor V. Maev"Consilium Medicum" Publishing housearticlefunctional gastrointestinal disordersfunctional dyspepsiairritable bowel syndromebiliary dysfunctionsphincter of oddi dysfunctionpostcholecystectomy syndromeMedicineRRUТерапевтический архив, Vol 93, Iss 8, Pp 897-903 (2021) |
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functional gastrointestinal disorders functional dyspepsia irritable bowel syndrome biliary dysfunction sphincter of oddi dysfunction postcholecystectomy syndrome Medicine R |
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functional gastrointestinal disorders functional dyspepsia irritable bowel syndrome biliary dysfunction sphincter of oddi dysfunction postcholecystectomy syndrome Medicine R Dmitry N. Andreev Igor V. Maev Efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study |
description |
Aim. Evaluation of the practice of using trimebutine (tablets, 300 mg, extended release), for the treatment of patients with functional gastrointestinal disorders (FGID) in primary health care.
Materials and methods. A prospective observational multicenter non-interventional study was carried out, which included patients of both sexes aged 18 to 60 years with a verified diagnosis of functional gastrointestinal disorders (functional dyspepsia, irritable bowel syndrome, biliary tract dysfunction, sphincter of Oddi dysfunction, postcholecystectomy syndrome). Trimebutine was prescribed in accordance with the instructions for medical use: orally, 300 mg twice per day for 28 days. The severity of simptoms was evaluated by five-point rating scale.
Results. The study included 4433 patients, the per protocol sample consisted of 3831 people. The proportion of patients with a significant decrease in the severity of abdominal pain after treatment was 74.73% (95% confidence interval CI 73.3276.11). At the and of the study a statistically significant decrease in the severity of FGID` simptoms was observed: epigastric pain/burning (mean score at the 1st visit was 1.21 [95% CI 1.181.25], at the 2nd visit 0.22 [95% CI 0.20.23]; p0.001), abdominal pain (1st visit 2.01 [95% CI 1.982.04), 2nd visit 0.33 [95% CI 0.310.35]; p0.001), biliary pain (1st visit 1.22 [95% CI 1.181.26], 2nd visit 0.2 [95% CI 0.190.22]; p0.001), postprandial fullness and early satiation (1st visit 1.29 [95% CI 1.251.32], 2nd visit 0.21 [95% CI 0.190.22]; p0.001), severity of heartburn (1st visit 0.92 [95% CI 0.880.95], 2nd visit 0.18 [95% CI 0.170.20]; p0.001), belching (1st visit 1.13 [95% CI 1.091.16], 2nd visit 0.22 [95% CI 0.210.24]; p0.001), as well as abdominal distention (1st visit 1.99 (95% CI 1, 96, 2.03), 2nd visit 0.43 [95% CI 0.410.45]; p0.001).
Conclusion. The present prospective observational multicenter non-interventional study has demonstrated that trimebutine is an effective approach to treating FGID. |
format |
article |
author |
Dmitry N. Andreev Igor V. Maev |
author_facet |
Dmitry N. Andreev Igor V. Maev |
author_sort |
Dmitry N. Andreev |
title |
Efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study |
title_short |
Efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study |
title_full |
Efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study |
title_fullStr |
Efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study |
title_full_unstemmed |
Efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study |
title_sort |
efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study |
publisher |
"Consilium Medicum" Publishing house |
publishDate |
2021 |
url |
https://doaj.org/article/31a3bd3ed87e4946bfb86be231e66c41 |
work_keys_str_mv |
AT dmitrynandreev efficacyoftrimebutineinthetreatmentoffunctionalgastrointestinaldisordersanobservationalmulticenterstudy AT igorvmaev efficacyoftrimebutineinthetreatmentoffunctionalgastrointestinaldisordersanobservationalmulticenterstudy |
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1718405165993689088 |