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      Safety of Pelargonium extract EPs 7630 in young children with acute bronchitis

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          Abstract

          Background

          The efficacy and tolerability of Pelargonium sidoides DC. root extract EPs 7630 in children with acute bronchitis (AB) have been widely demonstrated. We investigated the safety and tolerability of a syrup formulation and an oral solution in pre-school children.

          Methods

          In an open-label, randomized clinical trial (EudraCT number 2011-002652-14), children aged 1–5 years suffering from AB received EPs 7630 syrup or solution for 7 days. Safety was assessed by frequency, severity, and nature of adverse events (AE), vital signs, and laboratory values. Outcome measures for evaluating the health status were the intensity of coughing, pulmonary rales, and dyspnea, measured by the short version of the Bronchitis Severity Scale (BSS-ped), further symptoms of the respiratory infection, general health status according to the Integrative Medicine Outcomes Scale (IMOS), and satisfaction with treatment according to the Integrative Medicine Patient Satisfaction Scale (IMPSS).

          Results

          591 children were randomized and treated with syrup ( n = 403) or solution ( n = 188) for 7 days. In both treatment groups, the number of adverse events was similarly low and revealed no safety concerns. The most frequently observed events were infections (syrup: 7.2%; solution: 7.4%) or gastrointestinal disorders (syrup: 2.7%; solution: 3.2%). After one week's treatment, more than 90% of the children experienced an improvement or remission of the symptoms of the BSS-ped. Further respiratory symptoms decreased similarly in both groups. At Day 7, more than 80% of the whole study population had completely recovered or showed a major improvement as assessed by the investigator and the proxy, respectively. Parents were “very satisfied” or “satisfied” with the treatment in 86.1% of patients in the combined syrup and solution group.

          Conclusion

          Both pharmaceutical forms, EPs 7630 syrup and oral solution, were shown to be equally safe and well tolerated in pre-school children suffering from AB. Improvement of health status and of complaints were similar in both groups.

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          Most cited references38

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          Extrapulmonary manifestations of severe respiratory syncytial virus infection – a systematic review

          Introduction Respiratory syncytial virus (RSV) bronchiolitis is the most important cause for admission to the paediatric intensive care unit in infants with lower respiratory tract infection. In recent years the importance of extrapulmonary manifestations of RSV infection has become evident. This systematic review aimed at summarizing the available evidence on manifestations of RSV infection outside the respiratory tract, their causes and the changes in clinical management required. Methods Databases searched were Medline (1950 to present), EMBASE (1974 to present), PubMed and reference lists of relevant articles. Summarized were the findings of articles reporting on manifestations of RSV infection outside the respiratory tract in patients of all age groups. Results Extrapulmonary manifestations reported in previous observational studies included cardiovascular failure with hypotension and inotrope requirements associated with myocardial damage as evident from elevated cardiac troponin levels (35–54% of ventilated infants), cardiac arrhythmias like supraventricular tachycardias and ventricular tachycardias, central apnoeas (16–21% of admissions), focal and generalized seizures, focal neurological abnormalities, hyponatraemia (33%) associated with increased antidiuretic hormone secretion, and hepatitis (46–49% of ventilated infants). RSV or its genetic material have been isolated from cerebrospinal fluid, myocardium, liver and peripheral blood. Conclusion The data summarized indicate a systemic dissemination of RSV during severe disease. Cerebral and myocardial involvement may explain the association of RSV with some cases of sudden infant death. In infants with severe RSV infection cardiac rhythm, blood pressure and serum sodium need to be monitored and supportive treatment including fluid management adjusted accordingly.
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            Pelargonium sidoides extract for treating acute respiratory tract infections.

            Pelargonium sidoides (P. sidoides), also known as Umckaloabo, is a herbal remedy thought to be effective in the treatment of acute respiratory infections (ARIs).
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              Liver involvement during influenza infection: perspective on the 2009 influenza pandemic

              Please cite this paper as: Papic et al. (2011) Liver involvement during influenza infection: perspective on the 2009 influenza pandemic. Influenza and Other Respiratory Viruses 6(3), e2–e5. Elevation of liver transaminase levels is a frequent observation during systemic infections. The aim of our study was to investigate liver damage during pandemic 2009 influenza A/H1N1 infection in comparison with seasonal influenza. Serum levels of aspartate aminotransferase, alanine aminotransferase, and gamma‐glutamyl transpeptidase (GGT) were significantly higher in patients with pandemic influenza compared to seasonal influenza, which was strongly correlated with hypoxia. Moreover, a positive correlation between C‐reactive protein and serum GGT, alkaline phosphatase, and lactate dehydrogenase was noticed. Our findings support the hypothesis that the pandemic 2009 influenza A/H1N1 is an illness with a significant immune response to infection leading to hepatocellular injury.
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                Author and article information

                Contributors
                Journal
                Front Pediatr
                Front Pediatr
                Front. Pediatr.
                Frontiers in Pediatrics
                Frontiers Media S.A.
                2296-2360
                14 February 2023
                2023
                : 11
                : 1107984
                Affiliations
                [ 1 ]Children’s Hospital, Evangelic Hospital , Hamm, Germany
                [ 2 ]Faculty of Medicine, Pomeranian Medical University , Szczecin, Poland
                [ 3 ]Pediatric Practice , Kehl, Germany
                [ 4 ]Pediatric Practice , Detmold, Germany
                [ 5 ]General Practice , Remscheid, Germany
                [ 6 ]Research and Development, Dr. Willmar Schwabe GmbH & Co. KG , Karlsruhe, Germany
                Author notes

                Edited by: Thomas Brendler, PlantaPhile®, United States

                Reviewed by: Klaus Peter Latté, Independent researcher, Berlin, Germany Ludger Klimek, Centre for Rhinology and Allergology, Germany

                [* ] Correspondence: Wolfgang Kamin paediatrie.hamm@ 123456valeo-kliniken.de

                Specialty Section: This article was submitted to Pediatric Infectious Diseases, a section of the journal Frontiers in Pediatrics

                Abbreviations AE, Adverse event; ALT, Alanine aminotransferase; ARTIs, Acute respiratory tract infections; AST, Aspartate aminotransferase; CI, Confidence interval; CRP, C-reactive protein; IMOS, Integrative Medicine Outcomes Scale; IMPSS, Integrative Medicine Patient Satisfaction Scale; γGT, Gamma-glutamyltransferase.

                Article
                10.3389/fped.2023.1107984
                9971625
                36865690
                9749ff4e-5611-472e-8d3a-2b4bba573ff8
                © 2023 Kamin, Behre, Helm, Reling, Funk and Malek.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 25 November 2022
                : 19 January 2023
                Page count
                Figures: 2, Tables: 5, Equations: 0, References: 38, Pages: 0, Words: 0
                Funding
                Funded by: Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany, sponsored this research and funded its publication.
                Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany, sponsored this research and funded its publication.
                Categories
                Pediatrics
                Clinical Trial

                acute bronchitis,children,pelargonium sidoides dc. root extract (eps® 7630),clinical trial,safety

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