Possibilities of combined therapy in patients with functional biliary sphincter of Oddi disorder

Abstract

Introduction. The prevalence of functional biliary disorders continues to increase with insufficient effectiveness of existing treatment approaches. Among them, functional biliary disorders of sphincter of Oddi account for at least 50%.Objective. To study efficacy, safety and tolerability of a fixed combination of glycyrrhizic acid and ursodeoxycholic acid (Fosfogliv Urso) in capsule form in patients with functional biliary disorders of sphincter of Oddi.Materials and Methods. The study included 32 patients diagnosed with functional biliary sphincter of Oddi disorders established according to the Rome Criteria IV revision (2016). Patients received Fosfogliv Urso (250 mg ursodeoxycholic acid and 35 mg glycyrrhizic acid) 1 capsule 3 times a day for 8 weeks. Prior to treatment, all study participants underwent a standard set of laboratory and instrumental examinations.Results. Against the background of Fosfogliv Urso treatment, statistically significant decrease of biliary pain prevalence up to 48.3% (p < 0.001); intense biliary pain up to 11.4% (p < 0.0001); intensity of pain syndrome on visual analogue scale down to 1.7 ± 0.9 cm was registered (p < 0.0001). Alanine aminotransferase activity significantly decreased to 34.0 ± 4.0 U/L (p < 0.001). There was a tendency of choledochal diameter decrease to 0.57 ± 0.01 cm. Treatment efficacy was rated by patients as very good and good in 83.4% of cases. The safety profile was assessed as favorable and tolerability as satisfactory.Discussion. The results obtained were superior to those previously obtained for ursodeoxycholic acid monotherapy and confirmed the data of the previously conducted phase III study. The rationality of the combination is due to the mutual complementation and possible synergism of the pharmacological effects of glycyrrhizinic and ursodeoxycholic acids.Conclusion. The results obtained allow to recommend the prescription of Fosfogliv Urso in the complex scheme of treatment and prophylaxis of functional biliary disorders of sphincter of Oddi.