Evaluation of Blood Alcohol Concentrations after Oral Administration of a Fixed Combination of Thyme Herb and Primrose Root Fluid Extract to Children with Acute Bronchitis.

BACKGROUND

The application of alcohol-containing medicinal products to children has been a subject of discussion for many years. A safety threshold of 0.125‰ blood alcohol concentration following the administration of a single dose has been recommended by the European Medicines Agency.The aim of this clinical study was to prove the safety of administering a fixed combination of thyme herb and primrose root fluid extract (Bronchicum(®) Elixir) containing 4.9% ethanol.

METHODS

The herbal drug was administered for a period of 7-9 days to 16 children (ages 1-12 years) suffering from acute bronchitis for ≤ 48 h. After 3-5 days, a blood sample was taken 45 min (children ≥ 5 years: also 0 and 90 min) after application of the drug. The efficacy was assessed using the Bronchitis Severity Score. Global efficacy and tolerability were rated by the investigator and patients.

RESULTS

All measured blood ethanol concentrations were below the threshold (mean value after 45 min: 0.0029 ± 0.0057‰ and after 90 min: 0.0051 ± 0.0078‰). The Bronchitis Severity Score decreased from 6.6 ± 1.0 to 0.9 ± 1.6 points. Global efficacy was assessed as "very good" and "good" in 60% (investigator) and 80% (patients) of cases. Global tolerability was rated as "very good" and "good" in more than 90% of cases.

CONCLUSIONS

In conclusion, oral administration of the drug containing 4.9% ethanol to children (age 1-12 years) demonstrated a favourable risk/benefit ratio of the drug.