Treatment of acute bronchitis in children and adolescents. Non-interventional postmarketing surveillance study confirms the benefit and safety of a syrup made of extracts from thyme and ivy leaves
Marzian, O.
MMW Fortschritte der Medizin 149(27-28 (Suppl): 69-74
2007
ISSN/ISBN: 1438-3276 PMID: 17619603 Document Number: 613162
A surveillance study was carried out to investigate the benefits and tolerability of a syrup made from thyme and ivy leaf extracts (Bronchipret Saft) in children and adolescents (aged 2-17 years) with acute bronchitis and productive cough. Prerequisites for participation in the study were: productive cough for a maximum of two days, at least 10 coughing fits per day prior to treatment and a Bronchitis Severity Score (BSS) of at least five points. The primary outcome measure was the change in the clinical symptoms based on the BSS. Treatment was conducted using age-appropriate dosages on a case-to-case basis in accordance with the summary of product characteristics. Documentation of the treatment course was taken on treatment days 0, 4 and 10. For the descriptive, statistical evaluation of the surveillance study, the data from 1234 children and adolescents (623 boys and 611 girls) in the age groups <2 years (n=12), 2-5 years (n=372), 6-11 years (n=438) and 12-17 years (n=412) were available. The correspondence of the dosages to the age-specific recommendations of the valid summary of product characteristics varied from 81.7% to 93.9% in the different age groups. The average BSS value decreased from 8.8 points to 4.8 on treatment day 4 and to 1.3 points after ~10 days of treatment. Compared to the initial examination, the number of documented coughing fits decreased, on average, by 18.7 (81.3%) on day 10. The responder rates of the various age groups were 92.0-96.5%. The tolerability was very good to good in 96.5% of the cases. Two female patients had temporary, non-serious adverse drug reactions (stomach ache, mild nausea). Acute bronchitis with productive cough in (young) children and adolescents can be treated safely and effectively with the thyme and ivy syrup.
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