Treatment effect and safety of EPs^® 7630-solution in acute bronchitis in childhood: Report of a multicentre observational study☆

Abstract 

An open post-marketing surveillance study was conducted to examine the treatment effect and safety of EPs^® 7630-solution in the treatment of acute bronchitis in children.

This study included a total of 742 children (aged between 0 and 12 years) with acute bronchitis (83.4%) or acute exacerbations of chronic bronchitis (14.3%), who were treated with different doses of the herbal drug for up to 14 days. Five bronchitis specific symptoms (BSS) were summed up to give an overall measure of disease severity. Non-specific disease symptoms (loss of appetite, diarrhoea, headache, vomiting, and fever) were also recorded, together with adverse events and overall ratings of efficacy and tolerability.

The overall BSS score decreased during treatment from 6.0±3.0 points at baseline to 2.7±2.5 points after 7 days and to 1.4±2.1 points after 14 days. Remission or improvement in at least 80% of patients was recorded for all the individual component symptoms. The proportion of patients suffering from non-specific symptoms also substantially improved during treatment. For example, loss of appetite was present in 65.8% of patients at study begin, but only in 27.6% at the time point of last observation visit. In 88.3% of cases, the responsible physician rated the treatment as successful. Adverse events were minor and transitory.

In conclusion, EPs^® 7630-solution was shown to be a safe and an effective treatment option for acute bronchitis or acute exacerbations of chronic bronchitis in children.

Keywords: Acute bronchitis, Children, Herbal medicine, Bronchitis severity score, EPs^® 7630, Umckaloabo^®