Karina Schönknecht1, Andrzej M Fal2, Agnieszka Mastalerz-Migas3, Monika Joachimiak1, Zbigniew Doniec4. 1. Department of Scientific Information, Phytopharm Klęka Inc. 2. Department of Health Care Organization And Economy, National Institute of Public Health, National Institute of Hygiene, Warsaw, Poland, Clinical Department of Internal Medicine and Allergology, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland. 3. Department of Family Medicine, Medical University, Wrocław, Poland. 4. Department of Allergology and Pneumonology, National Research Institute for Tuberculosis and Lung Disease, Rabka Zdroj Branch, Rabka-Zdrój, Poland.
Abstract
OBJECTIVE: Introduction: Coughing is a physiological, spontaneous defense mechanism against irritants that stimulate respiratory mucosa. Productive cough should be not suppressed; instead, mucus-dissolving agents are recommended. One of the expectorants, which increases the excretion volume, is the herbal medicine derived from ivy leaves. The ivy extract contains triterpene saponins, which have secretory properties. The aim of this study was to determine the effectiveness and safety of the treatment with the medicinal product Hedussin®, containing dry ivy extract, in the therapy of productive cough in the course of the respiratory tract infection. PATIENTS AND METHODS: Material and methods:This was a non-randomized, non-interventional, multicenter, open-label, post-authorization effectiveness study (PAES). The study group consisted of 464 patients aged 2-12 years with productive cough. The study was supported by a questionnaire that included: the type of cough etiological factor, Bronchitis Severity Score (BSS), temperature, and prescription of antibiotic therapy. Effectiveness and safety of the therapy with Hedussin® was assessed at the follow-up visit. RESULTS: Results and conclusion: Improvement in cough was reported in 93.3% subjects; improvement in chest pain on coughing was reported in 84.7%, in wheezing - in 90.0%, in dyspnoea - in 88.7%, and in auscultation changes - in 94.8%. In addition, decline or normalization of body temperature was found in 96.0% of subjects. No adverse drug reactions were reported in the study population. The non-antibiotic treated group showed similar proportions. The results of this study support the efficacy of Hedussin® prescribed for the treatment of productive cough in the course of respiratory tract infections. Hedussin® was well tolerated by sick children aged 2-12 years.
OBJECTIVE: Introduction: Coughing is a physiological, spontaneous defense mechanism against irritants that stimulate respiratory mucosa. Productive cough should be not suppressed; instead, mucus-dissolving agents are recommended. One of the expectorants, which increases the excretion volume, is the herbal medicine derived from ivy leaves. The ivy extract contains triterpenesaponins, which have secretory properties. The aim of this study was to determine the effectiveness and safety of the treatment with the medicinal product Hedussin®, containing dry ivy extract, in the therapy of productive cough in the course of the respiratory tract infection. PATIENTS AND METHODS: Material and methods:This was a non-randomized, non-interventional, multicenter, open-label, post-authorization effectiveness study (PAES). The study group consisted of 464 patients aged 2-12 years with productive cough. The study was supported by a questionnaire that included: the type of cough etiological factor, Bronchitis Severity Score (BSS), temperature, and prescription of antibiotic therapy. Effectiveness and safety of the therapy with Hedussin® was assessed at the follow-up visit. RESULTS: Results and conclusion: Improvement in cough was reported in 93.3% subjects; improvement in chest pain on coughing was reported in 84.7%, in wheezing - in 90.0%, in dyspnoea - in 88.7%, and in auscultation changes - in 94.8%. In addition, decline or normalization of body temperature was found in 96.0% of subjects. No adverse drug reactions were reported in the study population. The non-antibiotic treated group showed similar proportions. The results of this study support the efficacy of Hedussin® prescribed for the treatment of productive cough in the course of respiratory tract infections. Hedussin® was well tolerated by sick children aged 2-12 years.
Authors: Peter Kardos; Walter Lehmacher; Andrea Zimmermann; Juliette Brandes-Schramm; Petra Funk; Heinrich Matthys; Wolfgang Kamin Journal: Multidiscip Respir Med Date: 2022-08-03