{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T13:55:38Z","timestamp":1790776538140,"version":"4.1.0"},"reference-count":37,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2020,7,8]],"date-time":"2020-07-08T00:00:00Z","timestamp":1594166400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Medicina"],"abstract":"<jats:p>Background and Objectives: Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders; it has a great impact on patient quality of life and is difficult to treat satisfactorily. This study evaluates the efficacy and safety of trimebutine maleate (TM) in patients with FD. Materials and Methods: A multicenter, randomized, double-blind, placebo controlled, prospective study was conducted, including 211 patients with FD. Participants were randomized to receive TM 300 mg twice per day (BID, 108 patients) or placebo BID (103 patients) for 4 weeks. The Glasgow Dyspepsia Severity Score (GDSS) was used to evaluate the relief of dyspepsia symptoms. Moreover, as a pilot secondary endpoint, a substudy (eight participants on TM and eight on placebo) was conducted in to evaluate gastric emptying (GE), estimated using a 99mTc-Tin Colloid Semi Solid Meal Scintigraphy test. Results: Of the 211 patients enrolled, 185 (87.7%) (97 (52.4%) in the TM group and 88 (47.6%) in the placebo group) completed the study and were analyzed. The groups did not differ in their demographic and medical history data. Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit (p-value = 0.02). The 99 mTc-Tin Colloid Semi Solid Meal Scintigraphy testing showed that TM significantly accelerated GE obtained at 50 min (median emptying 75.5% in the TM group vs. 66.6% in the placebo group, p = 0.036). Adverse effects of low to moderate severity were reported in 12.3% of the patients on TM. Conclusion: TM monotherapy appears to be an effective and safe approach to treating FD, although the findings presented here warrant further confirmation.<\/jats:p>","DOI":"10.3390\/medicina56070339","type":"journal-article","created":{"date-parts":[[2020,7,8]],"date-time":"2020-07-08T11:47:46Z","timestamp":1594208866000},"page":"339","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Trimebutine Maleate Monotherapy for Functional Dyspepsia: A Multicenter, Randomized, Double-Blind Placebo Controlled Prospective Trial"],"prefix":"10.3390","volume":"56","author":[{"given":"Jannis","family":"Kountouras","sequence":"first","affiliation":[{"name":"Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Gavalas","sequence":"additional","affiliation":[{"name":"Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3563-4973","authenticated-orcid":false,"given":"Apostolis","family":"Papaefthymiou","sequence":"additional","affiliation":[{"name":"Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece"},{"name":"Department of Gastroenterology, University General Hospital of Larissa, Mezourlo, 41334 Larissa, Thessaly, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ioannis","family":"Tsechelidis","sequence":"additional","affiliation":[{"name":"Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9232-4042","authenticated-orcid":false,"given":"Stergios A.","family":"Polyzos","sequence":"additional","affiliation":[{"name":"Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece"},{"name":"First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, 54124 Thessaloniki, Macedonia, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5766-9598","authenticated-orcid":false,"given":"Serhat","family":"Bor","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Ege University School of Medicine, 35330 Izmir, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mircea","family":"Diculescu","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Department, Clinic Fundeni Institute, 4204003 Bucharest, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u039ahaled","family":"Jadallah","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, King Abdullah University Hospital, 22110 Irbid, Jordan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mazurek","family":"Tadeusz","sequence":"additional","affiliation":[{"name":"Medicor Centrum, ul. Jab\u0142oskiego 2\/4, 35-068 Rzesz\u00f3w, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarkan","family":"Karakan","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Gazi University School of Medicine, 06560 Ankara, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Bochenek","sequence":"additional","affiliation":[{"name":"Centrum Badawcze Wspolczesnej Terapii, 02679 Warszawa, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerzy","family":"Rozciecha","sequence":"additional","affiliation":[{"name":"LexMedica, Rudolfa Weigla 12, Krzyki, 53114 Wroc\u0142aw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Dabrowski","sequence":"additional","affiliation":[{"name":"Department of Rheumatology of Clinical Hospital 2, University of Rzeszow, Lwowska 60, 35-301 Rzeszow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zeno","family":"Sparchez","sequence":"additional","affiliation":[{"name":"Third Medical Clinic, University of Medicine and Pharmacy, Croitorilor Street no.19-21, 400162 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orhan","family":"Sezgin","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Faculty of Medicine, Mersin University, 33343 Mersin, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Macit","family":"G\u00fclten","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Uludag University, 16059 Bursa, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niazy Abu","family":"Farsakh","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, King Abdullah University Hospital, 22110 Irbid, Jordan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0396-5081","authenticated-orcid":false,"given":"Michael","family":"Doulberis","sequence":"additional","affiliation":[{"name":"Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece"},{"name":"First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, 54124 Thessaloniki, Macedonia, Greece"},{"name":"Division of Gastroenterology and Hepatology, Medical University Department, Kantonsspital Aarau, 5001 Aarau, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2020,7,8]]},"reference":[{"key":"ref_1","unstructured":"Francis, P., and Zavala, S.R. 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