Efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study

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Abstract

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 73.32–76.11). 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 1.18–1.25], at the 2nd visit – 0.22 [95% CI 0.2–0.23]; p<0.001), abdominal pain (1st visit – 2.01 [95% CI 1.98–2.04), 2nd visit – 0.33 [95% CI 0.31–0.35]; p<0.001), biliary pain (1st visit – 1.22 [95% CI 1.18–1.26], 2nd visit – 0.2 [95% CI 0.19–0.22]; p<0.001), postprandial fullness and early satiation (1st visit – 1.29 [95% CI 1.25–1.32], 2nd visit – 0.21 [95% CI 0.19–0.22]; p<0.001), severity of heartburn (1st visit – 0.92 [95% CI 0.88–0.95], 2nd visit – 0.18 [95% CI 0.17–0.20]; p<0.001), belching (1st visit – 1.13 [95% CI 1.09–1.16], 2nd visit – 0.22 [95% CI 0.21–0.24]; p<0.001), as well as abdominal distention (1st visit – 1.99 (95% CI 1, 96, 2.03), 2nd visit – 0.43 [95% CI 0.41–0.45]; p<0.001).

Conclusion. The present prospective observational multicenter non-interventional study has demonstrated that trimebutine is an effective approach to treating FGID.

About the authors

Dmitry N. Andreev

Yevdokimov Moscow State University of Medicine and Dentistry

Author for correspondence.
Email: dna-mit8@mail.ru
ORCID iD: 0000-0002-4007-7112

кандидат медицинских наук, доцент кафедры пропедевтики внутренних болезней и гастроэнтерологии

Russian Federation, Moscow

Igor V. Maev

Yevdokimov Moscow State University of Medicine and Dentistry

Email: dna-mit8@mail.ru
ORCID iD: 0000-0001-6114-564X

академик РАН, доктор медицинских наук, профессор, заведующий кафедрой пропедевтики внутренних болезней и гастроэнтерологии

Russian Federation, Moscow

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Supplementary files

Supplementary Files
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2. Fig.1. Patient distribution by the severity of abdominal pain at the beginning and at the end of the study in the «all study participants» population.

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3. Fig. 2. Dynamics of FGID` symptoms severity under treatment according to a five-point rating scale.

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4. Fig. 3. Dynamics of stool characteristics under treatment.

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