A non-interventional, observational study of a fixed combination of pepsin and amino acid hydrochloride in patients with functional dyspepsia

摘要

Functional dyspepsia (FD) is a gastrointestinal disorder characterized by recurrent and diverse symptoms and pathophysiology that remains unexplained following routine clinical investigation. Enzynorm?f is a pharmaceutical preparation comprising fixed amounts of pepsin of biological origin and organically bound acid in the form of amino acid hydrochloride. It is traditionally used as a mild agent to support gastric function and to stimulate the stomach’s proteolytic activities in FD. In a non-interventional, observational, post-marketing surveillance study, patients with an established diagnosis of FD were treated with a fixed combination of pepsin and amino acid hydrochloride taken as tablets three times daily for 6?weeks. The primary objective of this study was to assess the change in symptoms using the validated Gastrointestinal Symptom Score (GIS?). Secondary objectives included patients’ assessment of their gastrointestinal symptoms as well as treatment safety and tolerability. A total of 97 patients (mean age 58.4 ± 13.9?years; 63.2% females) were included in the study, with 72 data having GIS? score data at baseline and at 6?weeks, and 34 also at 3?weeks. The overall GIS? sum score decreased by 4.1 (p?