alexa Tolerability and Treatment Effects of Pelargonium sidoides Preparation EPs 7630 in Adults Suffering from Acute Rhinopharyngitis A Prospective, Open-Label Trial
ISSN: 2327-5162

Alternative & Integrative Medicine
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Research Article

Tolerability and Treatment Effects of Pelargonium sidoides Preparation EPs 7630 in Adults Suffering from Acute Rhinopharyngitis A Prospective, Open-Label Trial

Keck T1*, Strobl A2 and Stracke B3

1Department of Oto-laryngology, Elisabethinen GmbH Graz, Austria

2Department of ENT Medicine, Head and Neck Surgery, ENT Centre Linz, Austria

3Department of Clinical Research, Karlsruhe, Germany

*Corresponding Author:
Tilman Keck
Krankenhaus der Elisabethinen Graz GmbH
Elisabethinergasse 14, 8020 Graz, Austria
Tel: 43 316 70 63 1140
Fax : 43 316 70 63 1620
E-mail: [email protected]

Received date: October 12, 2015 Accepted date: October 30, 2015 Published date: November 6, 2015

Citation: Keck T, Strobl A, Stracke B (2015) Tolerability and Treatment Effects of Pelargonium sidoides Preparation EPs 7630 in Adults Suffering from Acute Rhinopharyngitis – A Prospective, Open-Label Trial. Altern Integr Med 4:204. doi:10.4172/2327-5162.1000204

Copyright: © 2015 Keck T, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Background: EPs 7630 has already been proven effective in acute rhinopharyngitis (ARP) and other acute respiratory diseases. We conducted an open-label, non-comparative, interventional multicenter study to obtain additional information on the tolerability and effectiveness of EPs 7630 in a clinical practice setting. Methods: 120 adults with clinical ARP diagnosis and at least 2 out of a set of 10 common cold symptoms received 3 × 1 film-coated 20 mg EPs 7630 tablet daily, for 10 days. Assessment of tolerability and safety was based on adverse event (AE) elicitation and safety laboratory measures. The intensity of ARP-associated symptoms was assessed daily and treatment outcome and satisfaction were evaluated. Results: At treatment end, 42% of patients were completely recovered, 42% showed major improvements. The majority of patients were satisfied with treatment. Over-all AE incidences were 0.017 (all AEs) and 0.010 (potentially related AEs) events/day of exposure. Most common events were gastrointestinal complaints and skin reactions. None of the events were serious. Conclusions: The results confirm the excellent tolerability of EPs 7630. Potentially attributable AEs were limited to the drug’s known spectrum of adverse effects. The majority of patients showed a favorable course of ARP which is unlikely to be explained by the natural course of the disease alone.

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