Abstract
BackgroundFunctional 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.MethodsIn 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.ResultsA 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 < 0.0001) from 11.6 (±4.8) at baseline to 7.4 (± 4.6) reflecting an improvement of clinical symptomatology after 6 weeks of treatment. In a subgroup of 70 patients who had FD meeting the Rome III criteria a GIS© score reduction of ≥50% was observed after 3 weeks treatment in 24% and in 30.8% after 6 weeks. Adverse events were mostly gastrointestinal in nature and consistent with the underlying disease; no unexpected adverse reactions were reported. Twenty-seven patients discontinued the study, mostly because of gastrointestinal symptoms.ConclusionThe results of this study support the efficacy of a fixed combination of pepsin and amino acid hydrochloride for the treatment of patients with FD and also suggest good to moderate treatment tolerability. These findings should be further explored in a randomised, placebo-controlled clinical trial.Clinical trial registrationThis study has been retrospectively registered in the ClinicalTrials.gov registry, trial identifier NCT03076411.
Highlights
Functional dyspepsia (FD) is a gastrointestinal disorder characterized by recurrent and diverse symptoms and pathophysiology that remains unexplained following routine clinical investigation
A number of treatment approaches are available, including proton pump inhibitors, eradication of Helicobacter pylori, prokinetic agents, and fundus-relaxing drugs [1, 3]; management of FD can be challenging mainly due to frequent relapse [3]
The primary objective was to assess the change of symptoms following treatment with a fixed combination of pepsin and amino acid hydrochloride when used as daily standard therapy over a period of approximately 6 weeks
Summary
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. Functional dyspepsia (FD) is a gastrointestinal disorder characterized by recurrent and diverse symptomatology and pathophysiology [1,2,3]. It leads to high costs due to diagnostics and medication, and can cause excess work absenteeism and decreased productivity [6, 7]
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