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

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          Abstract

          Background

          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.

          Methods

          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.

          Results

          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 < 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.

          Conclusion

          The 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 registration

          This study has been retrospectively registered in the ClinicalTrials.gov registry, trial identifier NCT03076411.

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          Most cited references15

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          Epidemiology of functional dyspepsia: a global perspective.

          Dyspepsia refers to group of upper gastrointestinal symptoms that occur commonly in adults. Dyspepsia is known to result from organic causes, but the majority of patients suffer from non-ulcer or functional dyspepsia. Epidemiological data from population-based studies of various geographical locations have been reviewed, as they provide more realistic information. Population-based studies on true functional dyspepsia (FD) are few, due to the logistic difficulties of excluding structural disease in large numbers of people. Globally, the prevalence of uninvestigated dyspepsia (UD) varies between 7%-45%, depending on definition used and geographical location, whilst the prevalence of FD has been noted to vary between 11%-29.2%. Risk factors for FD have been shown to include females and underlying psychological disturbances, whilst environmental/ lifestyle habits such as poor socio-economic status, smoking, increased caffeine intake and ingestion of non-steroidal anti-inflammatory drugs appear to be more relevant to UD. It is clear that dyspepsia and FD in particular are common conditions globally, affecting most populations, regardless of location.
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            Guidelines for the management of dyspepsia.

            Dyspepsia is a chronic or recurrent pain or discomfort centered in the upper abdomen; patients with predominant or frequent (more than once a week) heartburn or acid regurgitation, should be considered to have gastroesophageal reflux disease (GERD) until proven otherwise. Dyspeptic patients over 55 yr of age, or those with alarm features should undergo prompt esophagogastroduodenoscopy (EGD). In all other patients, there are two approximately equivalent options: (i) test and treat for Helicobacter pylori (H. pylori) using a validated noninvasive test and a trial of acid suppression if eradication is successful but symptoms do not resolve or (ii) an empiric trial of acid suppression with a proton pump inhibitor (PPI) for 4-8 wk. The test-and-treat option is preferable in populations with a moderate to high prevalence of H. pylori infection (> or =10%); empirical PPI is an initial option in low prevalence situations. If initial acid suppression fails after 2-4 wk, it is reasonable to consider changing drug class or dosing. If the patient fails to respond or relapses rapidly on stopping antisecretory therapy, then the test-and-treat strategy is best applied before consideration of referral for EGD. Prokinetics are not currently recommended as first-line therapy for uninvestigated dyspepsia. EGD is not mandatory in those who remain symptomatic as the yield is low; the decision to endoscope or not must be based on clinical judgement. In patients who do respond to initial therapy, stop treatment after 4-8 wk; if symptoms recur, another course of the same treatment is justified. The management of functional dyspepsia is challenging when initial antisecretory therapy and H. pylori eradication fails. There are very limited data to support the use of low-dose tricyclic antidepressants or psychological treatments in functional dyspepsia.
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              Functional dyspepsia impacts absenteeism and direct and indirect costs.

              Functional dyspepsia (FD) is a common morbid condition but data are limited on the direct and indirect costs for employees with FD or on its impact on productivity. Few data on absenteeism and no objective information are available. This study aimed to assess the impact of FD on costs and effects on absenteeism and work output (productivity). We performed a retrospective analysis of payroll data and adjudicated health insurance medical and prescription claims collected over a 4-year study period (January 1, 2001 to December 31, 2004) from more than 300,000 employees. Data from employees with and without (controls) FD were compared using 2-part regression techniques. Outcome measures included medical (total and by place of service) and prescription costs, absenteeism, and objectively measured productivity output. Employees with FD (N = 1669) had greater average annual medical and prescription drug costs and indirect costs (owing to sick leave and short- and long-term disability absences) than controls (N = 274,206). Compared with controls, the FD employees incurred costs that were $5138 greater and had greater costs for each place of service (all P < .0001). The employees with FD had an additional 0.83 absence days per year and produced 12% fewer units per hour than controls (both P < .05). Employees with FD have greater costs at all places of service and lower productivity than employees without FD. Copyright 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                kris.fors@online.de
                l.meier@immanuel.de
                b.uehleke@gmx.net
                cornelia.breuer@nordmark-pharma.de
                r.stange@immanuel.de
                Journal
                BMC Gastroenterol
                BMC Gastroenterol
                BMC Gastroenterology
                BioMed Central (London )
                1471-230X
                25 November 2017
                25 November 2017
                2017
                : 17
                : 123
                Affiliations
                [1 ]ISNI 0000 0004 0606 2229, GRID grid.476583.b, Nordmark Arzneimittel GmbH & Co. KG, ; Pinnauallee 4, D-25436 Uetersen, Germany
                [2 ]ISNI 0000 0001 2218 4662, GRID grid.6363.0, Charité - University Medicine Berlin and Immanuel Krankenhaus, ; Koenigstrasse 63, D-14109 Berlin, Germany
                Author information
                http://orcid.org/0000-0002-8882-9862
                Article
                675
                10.1186/s12876-017-0675-9
                5702133
                29178842
                5714547b-d16b-4987-9344-33b1c60738de
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 20 March 2017
                : 15 November 2017
                Funding
                Funded by: Nordmark Arzneimittel GmbH & Co. KG
                Award ID: NM-Efo-401
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2017

                Gastroenterology & Hepatology
                functional dyspepsia,observational trial,non-interventional trial,natural remedy,enzyme therapy,pepsin

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