Trimebutine Maleate Monotherapy for Functional Dyspepsia: A Multicenter, Randomized, Double-Blind Placebo Controlled Prospective Trial

Kountouras, Jannis; Gavalas, Emmanuel; Papaefthymiou, Apostolis; Tsechelidis, Ioannis; Bor, Serhat; Diculescu, Mircea; Jadallah, Κhaled; Tadeusz, Mazurek; Karakan, Tarkan; Bochenek, Αnna; Rozciecha, Jerzy; Dąbrowski, Piotr; Spârchez, Zeno; Sezgın, Orhan; Gülten, Macit; Farsakh, Niazy Abu; Doulberis, Michael

doi:10.3390/medicina56070339

Cited by 12 publications

(12 citation statements)

References 34 publications

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“…по применению тримебутина в рамках монотерапии ФД первичная конечная точка (облегчение симптомов) достоверно достигнута в группе, принимавшей тримебутин, ко 2-му визиту пациентов (через 2 нед) и последнему (через 4 нед); ORIGINAL ARTICLE p=0,02) [29]. При этом сцинтиграфическое исследование с применением 99m Tc-Tin продемонстрировало, что тримебутин способствует ускорению эвакуаторной функции желудка достоверно эффективнее, чем плацебо (p=0,036) [29]. Эффективность тримебутина в рамках купирования боли при лечении ФЗ ЖКТ (СРК, ФД и их сочетания) в сравнении с другими спазмолитиками продемонстрирована в исследовании В.Т.…”

Section: Discussionunclassified

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

Andreev

Николаеви²,

Маев

et al. 2021

Terapevticheskii arkhiv

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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.

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Section: Discussionunclassified

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

Andreev

Николаеви²,

Маев

et al. 2021

Terapevticheskii arkhiv

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“…• Пациентам с хроническим гастритом и симптомами диспепсии (особенно такими, как переполнение в эпигастрии и раннее насыщение), в том числе в сочетании с функциональной диспепсией, в качестве симптоматического лечения рекомендуется проведение терапии препаратами, обладающими прокинетическим эффектом [32, [114][115][116][117][118]. [119,120]. Способность тримебутина купировать симптомы диспепсии подтверждена в масштабных проспективных неинтервенционных исследованиях, проведенных в РФ, общее число участников которых составило 4533 человека [121,122].…”

Section: уровень убедительности рекомендаций а (уро вень достоверност...unclassified

“…Способность тримебутина купировать симптомы диспепсии подтверждена в масштабных проспективных неинтервенционных исследованиях, проведенных в РФ, общее число участников которых составило 4533 человека [121,122]. Сцинтиграфия с коллоидной полутвердой пищей, меченной 99 mTc-Tin, показала, что тримебутин нормализует опорожнение желудка [120]. По данным сетевого метаанализа, посвященного оценке препаратов с прокинетическим действием при функциональной диспепсии, тримебутин продемонстрировал сопоставимую с метоклопрамидом** и домперидоном эффективность по показателю поверхности под кумулятивной кривой распределения (surface under the cumulative ranking curve -SUCRA) [116].…”

Section: уровень убедительности рекомендаций а (уро вень достоверност...unclassified

Clinical Recommendations of Russian Gastroenterological Association and RENDO Endoscopic Society on Diagnosis and Treatment of Gastritis and Duodenitis

Ивашкин

Маев

Лапина

et al. 2021

Rossijskij žurnal gastroènterologii, gepatologii, koloproktolog

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Aim. The clinical guidelines are intended to supplement specialty decision-making for improved aid quality in patients with gastritis and duodenitis though acknowledging the latest clinical evidence and principles of evidencebased medicine.Key points. Gastritis is an inflammatory disease of stomach mucosa, with a separate definition of acute and chronic gastritis. Chronic gastritis is a cohort of chronic diseases uniting a typical morphology of persistent inflammatory infiltration, impaired cellular renewal with emergent intestinal metaplasia, atrophy and epithelial dysplasia of gastric mucosa. Oesophagogastroduodenoscopy (OGDS) or high-resolution OGDS with magnified or non-magnified virtual chromoendoscopy, including targeted biopsy for atrophy and intestinal metaplasia grading and neoplasia detection, are recommended to verify gastritis and duodenitis, precancer states and/or gastric mucosal changes. All chronic gastritis patients positive for H. рylori should undergo eradication therapy as aetiological and subsidiary for gastric cancer prevention. Chronic gastritis patients with symptoms of dyspepsia (epigastric pain, burning and congestion, early satiety), also combined with functional dyspepsia, are recommended proton pump inhibitors, prokinetics, rebamipide and bismuth tripotassium dicitrate in symptomatic treatment. With focal restricted intestinal metaplasia, follow-up is not required in most cases, mainly when advanced atrophic gastritis is ruled out in high-quality endoscopy with biopsy. However, a familial history of gastric cancer, incomplete intestinal metaplasia and persistent H. pylori infection render endoscopy monitoring with chromoendoscopy and targeted biopsy desirable once in three years. Patients with advanced atrophic gastritis should have high-quality endoscopy every 3 years, and once in 1–2 years if complicated with a familial history of gastric cancer.Conclusion. The recommendations condense current knowledge on the aetiology and pathogenesis of gastritis and duodenitis, as well as laboratory and instrumental diagnostic techniques, main approaches to aetiological H. pylori eradication and treatment of dyspeptic states.

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“…In addition, despite being widely in use, prokinetic agents only demonstrate limited effectiveness. [ 4 – 10 ]…”

Section: Introductionmentioning

confidence: 99%

The clinical efficacy of acupoint sticking combined with massage to treatment functional dyspepsia

Jiang²,

Chun-xiang³

et al. 2020

Medicine

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Background: The objective of this meta-analysis was to summarize and identify the available evidence from studies to estimate the clinical value of acupoint sticking combined with massage (ASM) in the treatment of functional dyspepsia (FD), and provide clinicians with evidence on which to base their clinical decision making. Methods: This review will include all studies comparing clinical efficacy of ASM in the treatment of FD. The search strategy will be performed in 10 databases. We will not establish any limitations to language and publication status, published from inception to the August 2020. Two reviewers will screen, select studies, extract data, and assess quality independently. Outcome is alleviation of global dyspeptic symptoms, alleviation of individual dyspeptic symptoms, quality-of-life improvement, and safety. The methodological quality including the risk of bias of the included studies will be evaluated. We will carry out statistical analysis using RevMan 5.3 software. Results: This study will summarize current evidence to assess the efficacy and safety of ASM in the treatment of FD. Conclusion: The findings of this study will provide helpful evidence for the clinician, and will promote further studies, as well as studying the value of ASM. Registration number: INPLASY2020110072 (DOI number: 10.37766/inplasy2020.11.0072).

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Trimebutine Maleate Monotherapy for Functional Dyspepsia: A Multicenter, Randomized, Double-Blind Placebo Controlled Prospective Trial

Cited by 12 publications

References 34 publications

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

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

Clinical Recommendations of Russian Gastroenterological Association and RENDO Endoscopic Society on Diagnosis and Treatment of Gastritis and Duodenitis

The clinical efficacy of acupoint sticking combined with massage to treatment functional dyspepsia

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