[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].
OBJECTIVE
For the investigation of the benefits and tolerability of a syrup made of extracts from thyme and ivy (Bronchipret Saft) in children and adolescents (ages: 2-17 years) with acute bronchitis and productive cough, a non-interventional postmarketing surveillance study was carried out.


METHODS
Prerequisites for participation in the surveillance study were productive cough for a maximum of two days, at least ten coughing fits per day prior to the initiation of treatment (estimation of the parents or adolescent) 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 carried out using age-appropriate dosages prescribed by the doctor on a case-by-case basis in accordance with the summary of product characteristics. Documentation of the course of treatment for the surveillance study was to be taken on treatment days 0, 4 and 10.


RESULTS
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 about ten days of treatment. Compared to that of the initial examination, the number of documented coughing fits had decreased on the average by 18.7 (81.3%) on day 10. The responder rates of the various age groups were 92.0% to 96.5%. The tolerability was rated as very good to good by the physicians in 96.5% of the cases. Two female patients had temporary, not serious adverse drug reactions (stomache ache, mild nausea).


CONCLUSIONS
Acute bronchitis with productive cough in (young) children and adolescents can be treated safely and effectively with the thyme and ivy syrup. A ten-day treatment using age-appropriate dosages led to a clear improvement in the symptoms or cure with very good tolerability.
Marzian
Olav
O
Facharzt für Kinderheilkunde, Hannover.
D000208:Acute Disease; D000293:Adolescent; D000996:Antitussive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D003371:Cough / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D013943:Thymol / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D004338:Drug Combinations
D000996:Antitussive Agents; D010936:Plant Extracts; D013943:Thymol; C475160:thyme extract and ivy extract drug combination; D004338:Drug Combinations