Trimebutine: a review of clinical data in terms of efficacy and safety
https://doi.org/10.37489/2949-1924-0084
EDN: FZWUVE
Abstract
Actuality. This article presents the results of clinical studies of trimebutine maleate in functional gastrointestinal disorders (GIT).
The objective of the work is to analyze the use of trimebutine in clinical practice from the standpoint of efficacy and safety according to the results of clinical studies published in the literature.
Since the late 1960s, trimebutine maleate has found wide application in the treatment of functional GIT disorders, including functional dyspepsia (FD), functional biliary tract disorders (FDBT), and irritable bowel syndrome (IBS). Trimebutine is usually classified as an antispasmodic, but its unique properties make it a multifunctional drug. The efficacy of trimebutine for treating IBS has bee n confirmed in several meta-analyses and reviews. One of the first clinical studies showed that the drug effectively affected stress-induced motility disorders and abdominal pain in patients with IBS. A meta-analysis including 26 randomized controlled trials (RCTs) demonstrated the high efficacy and safety of trimebutine compared with other antispasmodics and placebo. Its efficacy was also confirmed for treating functional abdominal pain and dyspepsia in a meta-analysis of 22 RCTs involving 1,778 patients with IBS. In 2011, trimebutine was included in the Cochrane systematic review of drugs with different mechanisms of action for treating IBS. Numerous studies have demonstrated the effect of trimebutine on upper gastrointestinal motility and its efficacy as an antispasmodic and prokinetic agent for treating FD. The safety of trimebutine was also noted in postoperative paralytic ileus. Adverse reactions such as dizziness, nausea, vomiting, diarrhea, and dry mouth were reported in 4.1 % of cases (14 of 340 patients). It should also be noted that trimebutine is safe to use in pediatric practice. According to clinical studies, mild to moderate adverse reactions were observed in 7 % of patients treated with trimebutine, while no adverse effects were reported in more than 1.8 % of patients, and some of them could be related to the patient's health condition rather than the drug.
Keywords
Supporting agencies: The work was carried out without sponsorship
About the Authors
A. L. Khokhlov
Yaroslavl State Medical University
Russian Federation
Competing Interests:
Russian Federation
Alexandr L. Khokhlov, Dr. Sci (Med.), Professor, Academician of the Russian Academy of Sciences, Head of the Department, Rector
Department of Pharmacology and Clinical Pharmacology
Yaroslavl
Competing Interests:
Authors declare no conflict of interest requiring
disclosure in this article
Yu. V. Rybachkova
Yaroslavl State Medical University
Russian Federation
Competing Interests:
Russian Federation
Yulia V. Rybachkova, PhD, Cand. Sci. (Med), Assistant
Department of Pharmacology and Clinical Pharmacology
Yaroslavl
Competing Interests:
Authors declare no conflict of interest requiring
disclosure in this article
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For citations:
Khokhlov A.L., Rybachkova Yu.V. Trimebutine: a review of clinical data in terms of efficacy and safety. Patient-Oriented Medicine and Pharmacy. 2025;3(2):6-15. (In Russ.) https://doi.org/10.37489/2949-1924-0084. EDN: FZWUVE
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