Tolerance, safety and efficacy of Hedera helix 1 extract in inflammatory bronchial diseases under clinical practice conditions: A prospective, open, multicentre postmarketing study in 9657 patients

Phytomedicine

Volume 16, Issue 1, January 2009, Pages 17–24

• S. Fazio^a,
• J. Pouso^b,
• D. Dolinsky^c,
• A. Fernandez^d,
• M. Hernandez^e,
• G. Clavier^f,
• M. Hecker^{g, , 2,}

• ^a Megapharma, Leyenda Patria 2942/801, CP 11300, Montevideo, Uruguay
• ^b Cufre 1835, Montevideo, Uruguay
• ^c De los Juncos M32 S1, Ciudad de la Costa, Canelones, Uruguay
• ^d Rivera 6224, CP 11500, Montevideo, Uruguay
• ^e Londres No. 105 P. B. COL. COYOACAN C.P. 04000 Deleg. Coyoacan Mexico D.F.
• ^f Avenida 5 de Julio con calle Arismendi, Puerto La Cruz Estado Anzoátegui, CP 6023 Venezuela
• ^g Engelhard Arzneimittel GmbH & Co. KG, Herzbergstr. 3, 61138 Niederdorfelden, Germany

Available online 24 July 2006

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doi:10.1016/j.phymed.2006.05.003

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Abstract

In this postmarketing study 9657 patients (5181 children) with bronchitis (acute or chronic bronchial inflammatory disease) were treated with a syrup containing dried ivy leaf extract. After 7 days of therapy, 95% of the patients showed improvement or healing of their symptoms. The safety of the therapy was very good with an overall incidence of adverse events of 2.1% (mainly gastrointestinal disorders with 1.5%). In those patients who got concomitant medication as well, it could be shown that the additional application of antibiotics had no benefit respective to efficacy but did increase the relative risk for the occurrence of side effects by 26%. In conclusion, it is to say that the dried ivy leaf extract is effective and well tolerated in patients with bronchitis. In view of the large population considered, future analyses should approach specific issues concerning therapy by age group, concomitant therapy and baseline conditions.

Keywords

• Hedera helix;
• Bronchitis;
• Safety;
• Efficacy

Corresponding author. Tel.: +49 0 6101 539 662; fax: +49 0 6101 539 663.

1

Prospan^® in Venezuela and worldwide except Mexico: Panoto-s^®, Argentina: Athos^® and rest of Latin America: Abrilar^®.

2

Includes doctors from Argentina, Centroamerica, Chile, Colombia, Dominicana, Ecuador, Mexico, Paraguay, Peru, Uruguay and Venezuela.

Copyright © 2006 Elsevier GmbH. All rights reserved.