Universität zu Köln

Kamin, Wolfgang, Funk, Petra, Seifert, Georg, Zimmermann, Andrea and Lehmacher, Walter (2018). EPs 7630 is effective and safe in children under 6 years with acute respiratory tract infections: clinical studies revisited. Curr. Med. Res. Opin., 34 (3). S. 475 - 486. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1473-4877

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Abstract

Objective: Pelargonium sidoides preparation EPs 7630 has been proven safe and effective in acute respiratory tract infections (aRTIs), but data for young children have not been presented separately. This study reviewed clinical studies and presents an overview of known and newly analyzed data from children <6 years. Methods: MEDLINE and EMBASE were searched for interventional and non-interventional studies which investigated the effects of EPs 7630 in aRTIs and included children <6 years of age. Sub-group analyses for this age range were performed for symptom scales, global efficacy or effectiveness assessments, and safety outcomes. Results: Seven studies with 1067 children <6 years exposed to EPs 7630 were identified. Efficacy of EPs 7630 was significantly superior to placebo in reducing symptom intensity and time until complete recovery in two randomized, double-blind trials in patients with acute bronchitis (AB). Similar symptom time courses were observed in two non-comparative observational studies in AB. One non-comparative, open-label study was identified in acute tonsillopharyngitis (ATP), and one in acute rhinosinusitis (ARS). In both indications, nearly all children showed complete recovery or major symptom improvements during the treatment period, with changes that were similar to those observed in controlled trials investigating older patient populations. The results were supported by an additional observational study including children with various diagnoses of aRTIs. EPs 7630 was safe and well-tolerated. Conclusions: EPs 7630 is efficacious in children <6 years suffering from AB. The analyses also support the effectiveness of the product in ATP and in ARS. No safety concerns were identified.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kamin, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Funk, Petra UNSPECIFIED UNSPECIFIED UNSPECIFIED Seifert, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Zimmermann, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Lehmacher, Walter UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-204114
DOI:	10.1080/03007995.2017.1402754
Journal or Publication Title:	Curr. Med. Res. Opin.
Volume:	34
Number:	3
Page Range:	S. 475 - 486
Date:	2018
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1473-4877
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language HERBAL DRUG PREPARATION; ACUTE OTITIS-MEDIA; PELARGONIUM-SIDOIDES; ACUTE BRONCHITIS; VIRAL-INFECTIONS; SYNCYTIAL VIRUS; PRIMARY-CARE; DOUBLE-BLIND; IN-VITRO; EXTRACT Multiple languages Medicine, General & Internal; Medicine, Research & Experimental Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/20411