{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T21:34:51Z","timestamp":1773092091768,"version":"3.50.1"},"reference-count":28,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,3,7]],"date-time":"2026-03-07T00:00:00Z","timestamp":1772841600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"European Union NextGenerationEU","award":["#BG-RRP-2.004-0003-C01"],"award-info":[{"award-number":["#BG-RRP-2.004-0003-C01"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Medicina"],"abstract":"<jats:p>Background and Objectives: This prospective, non-interventional, multicenter study aims to assess the therapeutic effectiveness of trimebutine maleate in patients with functional gastrointestinal disorders (FGIDs) by patient-reported outcomes. Materials and Methods: The study encompassed 2501 patients from 50 clinical sites diagnosed with irritable bowel syndrome, functional dyspepsia, or other functional gastrointestinal diseases. A validated questionnaire, an adapted version of the Izumo scale, was employed for self-assessment of symptoms and quality of life related to gastrointestinal issues. Results: The findings indicate a significant decrease in symptom severity, encompassing epigastric pain, dyspeptic symptoms, and defecation difficulties, as early as the second visit, with mean pain scores declining from 2.65 to 0.46 (p &lt; 0.001). Conclusions: The data validate trimebutine\u2019s profile as a well-tolerated and efficacious therapy for patients with IBS in real-world clinical practice in Bulgaria. The findings endorse the prospective inclusion of trimebutine as a treatment option in forthcoming clinical guidelines.<\/jats:p>","DOI":"10.3390\/medicina62030499","type":"journal-article","created":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T11:06:52Z","timestamp":1773054412000},"page":"499","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Patient-Reported Epigastric Symptom Dynamics During Trimebutine Maleate Treatment: A Post-Marketing Study"],"prefix":"10.3390","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6165-5674","authenticated-orcid":false,"given":"Svetoslav","family":"Stoev","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences and Social Pharmacy, Faculty of Pharmacy, Medical University-Pleven, 5800 Pleven, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4205-7502","authenticated-orcid":false,"given":"Vesselina","family":"Yanachkova","sequence":"additional","affiliation":[{"name":"Research Institute, Medical University-Pleven, 5800 Pleven, Bulgaria"},{"name":"Department of Endocrinology, Specialized Hospital for Active Treatment of Obstetrics and Gynecology Dr. Shterev, 1330 Sofia, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1488-3863","authenticated-orcid":false,"given":"Elina","family":"Petkova-Gueorguieva","sequence":"additional","affiliation":[{"name":"Department of Health Management and Health Economics, Faculty of Public Health, Medical University of Sofia, 1000 Sofia, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0498-6172","authenticated-orcid":false,"given":"Stanislav","family":"Gueorguiev","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, Faculty of Pharmacy, Medical University Plovdiv, 4002 Plovdiv, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7103-3892","authenticated-orcid":false,"given":"Violeta","family":"Getova-Kolarova","sequence":"additional","affiliation":[{"name":"Department \u201cOrganization and Economics of Pharmacy\u201d, Faculty of Pharmacy, Medical University of Sofia, 1000 Sofia, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4835-6965","authenticated-orcid":false,"given":"Hristina","family":"Lebanova","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences and Social Pharmacy, Faculty of Pharmacy, Medical University-Pleven, 5800 Pleven, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vasil","family":"Koynarski","sequence":"additional","affiliation":[{"name":"VITA Multiprofile Hospital for Active Treatment, 1407 Sofia, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,7]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"137","DOI":"10.5056\/jnm.2013.19.2.137","article-title":"Patient-Reported Outcomes in Gastroenterology: Clinical and Research Applications","volume":"19","author":"Spiegel","year":"2013","journal-title":"J. Neurogastroenterol. Motil."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"957","DOI":"10.1016\/j.cgh.2011.06.014","article-title":"Patient-Reported Outcomes for Irritable Bowel Syndrome Are Associated With Patients\u2019 Severity Ratings of Gastrointestinal Symptoms and Psychological Factors","volume":"9","author":"Lackner","year":"2011","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Mo, J., Zeng, P., Zhou, L., Xia, B., Yang, X., and Li, Q. (2025). Outcome Measures for Irritable Bowel Syndrome: A Scoping Review. BMC Med. Res. Methodol., 25.","DOI":"10.1186\/s12874-025-02718-8"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"453","DOI":"10.1111\/nmo.12151","article-title":"FDA and EMA End Points: Which Outcome End Points Should We Use in Clinical Trials in Patients with Irritable Bowel Syndrome?","volume":"25","author":"Corsetti","year":"2013","journal-title":"Neurogastroenterol. 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Res."},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Yang, Y.J., Bang, C.S., Baik, G.H., Park, T.Y., Shin, S.P., Suk, K.T., and Kim, D.J. (2017). Prokinetics for the Treatment of Functional Dyspepsia: Bayesian Network Meta-Analysis. BMC Gastroenterol., 17.","DOI":"10.1186\/s12876-017-0639-0"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1257","DOI":"10.1053\/j.gastro.2016.03.035","article-title":"Rome IV\u2014Functional GI Disorders: Disorders of Gut-Brain Interaction","volume":"150","author":"Drossman","year":"2016","journal-title":"Gastroenterology"},{"key":"ref_10","first-page":"1478","article-title":"Development and verification of the Izumo Scale, new questionnaire for quality of life assessment of patients with gastrointestinal symptoms","volume":"106","author":"Furuta","year":"2009","journal-title":"Nihon Shokakibyo Gakkai Zasshi"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1111\/j.1365-2036.2005.02572.x","article-title":"Validation of the Gastrointestinal Symptom Score for the Assessment of Symptoms in Patients with Functional Dyspepsia","volume":"22","author":"Adam","year":"2005","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"920","DOI":"10.3109\/00365529709011203","article-title":"Stool Form Scale as a Useful Guide to Intestinal Transit Time","volume":"32","author":"Lewis","year":"1997","journal-title":"Scand. J. Gastroenterol."},{"key":"ref_13","unstructured":"IBM Corp (IBM SPSS Statistics for Windows, 2020). IBM SPSS Statistics for Windows, Version 30.0; Computer Software."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1262","DOI":"10.1053\/j.gastro.2016.02.032","article-title":"Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features, and Rome IV","volume":"150","author":"Drossman","year":"2016","journal-title":"Gastroenterology"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"320","DOI":"10.5056\/jnm14165","article-title":"Epidemiology of Functional Gastrointestinal Disorders in Japan and in the World","volume":"21","author":"Oshima","year":"2015","journal-title":"J. Neurogastroenterol. Motil."},{"key":"ref_16","unstructured":"EMA (2014). Guideline on the Evaluation of Medicinal Products for IBS, European Medicines Agency."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1053\/j.gastro.2020.04.014","article-title":"Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study","volume":"160","author":"Sperber","year":"2021","journal-title":"Gastroenterology"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"527","DOI":"10.1136\/gut.44.4.527","article-title":"Validation of a Specific Quality of Life Questionnaire for Functional Digestive Disorders","volume":"44","author":"Chassany","year":"1999","journal-title":"Gut"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1215","DOI":"10.1111\/j.1365-2036.2011.04640.x","article-title":"Functional Dyspepsia Impairs Quality of Life in the Adult Population: Functional Dyspepsia and Quality of Life","volume":"33","author":"Aro","year":"2011","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_20","first-page":"20","article-title":"Adherence to Therapy in Patients with Gastrointestinal Tract Pathology","volume":"26","author":"Alekseeva","year":"2016","journal-title":"Russ. J. Gastroenterol. Hepatol. Coloproctol."},{"key":"ref_21","first-page":"897","article-title":"Efficacy of Trimebutine in the Treatment of Functional Gastrointestinal Disorders: An Observational Multicenter Study","volume":"93","author":"Andreev","year":"2021","journal-title":"Ter. Arkhiv"},{"key":"ref_22","first-page":"111","article-title":"Functional Diseases of the Gastrointestinal Tract in the Context with Overlapping Functional Disorders: Current Status of the Problem","volume":"92","author":"Osadchuk","year":"2020","journal-title":"Ter. Arkhiv"},{"key":"ref_23","first-page":"193","article-title":"Efficacy of Trimebutine Therapy in Patients with Gastroesophageal Reflux Disease and Irritable Bowel Syndrome","volume":"49","author":"Kountouras","year":"2002","journal-title":"Hepatogastroenterology"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1391","DOI":"10.1016\/S0022-3565(24)38284-9","article-title":"Pharmacological Properties of Trimebutine and N-Monodesmethyltrimebutine","volume":"289","author":"Roman","year":"1999","journal-title":"J. Pharmacol. Exp. Ther."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"139","DOI":"10.15171\/mejdd.2017.64","article-title":"Association of Gastrointestinal Functional Disorders and Migraine Headache: A Population Base Study","volume":"9","author":"Lankarani","year":"2017","journal-title":"Middle East. J. Dig. Dis."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"304","DOI":"10.1111\/j.1440-1746.2006.04493.x","article-title":"Meta-analysis of the Effects of Prokinetic Agents in Patients with Functional Dyspepsia","volume":"22","author":"Hiyama","year":"2007","journal-title":"J. Gastro Hepatol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1111\/j.1365-2036.2006.02937.x","article-title":"Systematic Review: The Safety and Tolerability of Pharmacological Agents for Treatment of Irritable Bowel Syndrome\u2014A European Perspective","volume":"24","author":"Heading","year":"2006","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_28","doi-asserted-by":"crossref","unstructured":"Bosman, M., Smeets, F., Elsenbruch, S., Tack, J., Simr\u00e9n, M., Talley, N., Winkens, B., Masclee, A., and Keszthelyi, D. (2023). Placebo Response in Pharmacological Trials in Patients with Functional Dyspepsia\u2014A Systematic Review and Meta-analysis. Neurogastroenterol. 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