Trimebutine maleate in the treatment of functional biliary disorders: TRIBUNE study results

Abstract

Introduction. The term «functional disorders of the biliary tract and bile ducts» defines the conditions, which produce typical patterns of biliary pains in the absence of obvious signs of organic lesions of the gallbladder and bile ducts. The materials of the Rome IV consensus present the diagnostic criteria of their main types – functional disorders of the gall bladder and sphincter of Oddi. Vasilenko Clinic of Internal Diseases Propedeutics, Gastroenterology and Hepatology of the University Clinical Hospital No. 2 of Sechenov University carried out a noninterventional observational program to study the experience in using Trimedat® (trimebutine maleate) in the routine outpatient and inpatient practice in the treatment of patients with functional diseases of the biliary tract. Information partners of the program are the Russian Gastroenterological Association (RGA) and the Russian Society for the Study of the Liver (RSSL).Materials and methods. The program included patients of both sexes aged 18 to 65 years with ICD-10 diagnoses «spasm of the sphincter of Oddi» (K 83.4), «postcholecystectomy syndrome» (K 91.5), «other specified diseases of the gallbladder» (K 82.8) , «other specified diseases of the bile ducts» (K 83.8), «disorders of gallbladder and biliary tract in diseases classified elsewhere» (K 87.0), if the clinical picture was consistent with functional biliary disorders according to the Rome IV criteria and in cases when the doctor decided to prescribe Trimedat® therapy. Patients were observed for 28 ± 1 days. The dynamics of biliary pain and discomfort, as well as other symptoms (in particular, nausea, flatulence) were evaluated on the background of the therapy, using the Gastrointestinal Symptom Score Scale, in which the severity of each symptom is estimated by 7 grades (Alekseev N.Yu., 2006) with adding a section to evaluate the biliary disorders. In the presence of criteria for functional disorders of the gallbladder, an ultrasound control of the fraction of its discharge was carried out before and after the therapy.Results. 100 patients (33 (33%) men and 67 (67%) women, the average age 42.2 ± 13.2 years (18–65 years)) were enrolled in the program. In accordance with the Rome IV Consensus, the majority of patients (83 (83%)) had the functional disorders of GB; in 16 (16%) patients with the removed GB, the picture corresponded to the functional disorder of SO, one patient with kept GB was diagnosed with SO dysfunction. The treatment with Trimedate® at a standard dosage resulted in a decrease in the proportion of pain in the epigastric region (in the Scale section evaluating the biliary tract symptoms), the degree of nausea and bloating. Differences between the visits were estimated by the Friedman’s test, p <0.001. In addition, other sections of the scale also showed a decrease in indicators in scores. 79 patients underwent repeated ultrasound cholecystography at the end of treatment. It showed an increase in the fraction of GB emptying.Conclusions. The use of Trimedate® in patients with functional disorders of the gall bladder and sphincter of Oddi resulted in the reduction of the severity of the main symptoms - the severity of biliary pain, nausea, bloating. The patients with GB dysfunction showed an increase in the fraction of GB emptying.