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Original Research

Efficacy and tolerability of EPs 7630 in children and adolescents with acute bronchitis – A randomized, double-blind, placebo-controlled multicenter trial with a herbal drug preparation from Pelargonium sidoides roots

W. Kamin, V. Maydannik, F.A. Malek and M. Kieser

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Volume 48 p. 184 - 191

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 48 – No. 3/2010 (184-191)

W. Kamin¹, V. Maydannik², F.A. Malek³ and M. Kieser⁴

¹University Hospital Pediatrics, Mainz, Germany, ²Pediatrics Faculty, National Medical University of Ukraine, Kiev, Ukraine, ³Dr. Willmar Schwabe GmbH & Co. KG Pharmaceuticals, Clinical Research Department, Karlsruhe and ⁴Institute of Medical Biometry and Informatics, Ruprecht-Karls-University Heidelberg, Heidelberg, Germany
Objective: The study aim was to demonstrate the efficacy and to investigate the tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides roots, in the treatment of patients (1 – 18 years) with acute bronchitis outside the strict indication for antibiotics. Materials and methods: A total of 200 patients were randomized to receive either active drug containing EPs 7630 (1 – 6 years: 3 × 10 drops/d; > 6 – 12 years: 3 × 20 drops/d; > 12 – 18 years: 3 × 30 drops/d) or placebo for 7 consecutive days. Primary outcome measure: change in the total score of bronchitis-specific symptoms (BSS) from Day 0 to Day 7. Main secondary outcome measures: treatment outcome, patients’ satisfaction with treatment, onset of effect, bed rest. Results: From baseline to Day 7, the mean BSS score improved significantly more for EPs 7630 compared with placebo (3.4 ± 1.8 vs. 1.2 ± 1.8 points, p < 0.0001). On Day 7, treatment outcome was significantly better (p < 0.0001), satisfaction with treatment more pronounced (77.6% vs. 25.8%, p < 0.0001), onset of effect faster, and time of bed rest shorter as compared with placebo. Tolerability was similarly good in both groups. All adverse events were assessed as non-serious. Conclusion: EPs 7630 was shown to be efficacious and safe in the treatment of acute bronchitis in children and adolescents outside the strict indication for antibiotics with patients treated with EPs 7630 perceiving a more favorable course of the disease and a good tolerability as compared with placebo.Correspondence to:
W. Kamin, PD
University Hospital Pediatrics
Langenbeckstr. 1
55101 Mainz, Germany
Email: [email protected]

Originalarbeit

Antibiotikaeinsatz bei COPD-Patienten im Rahmen einer Add-on-Therapie mit EPs 7630

Antibiotic use in patients with COPD receiving EPs 7630 as an add-on treatment

H. Matthys und F.A. Malek

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Jahrgang 41 p. 27 - 34

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