Treatment of acute bronchitis with EPs 7630: Randomized, controlled trial in children and adolescents

Background: The aim of this trial was to investigate the efficacy and tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides, in children and adolescents suffering from acute bronchitis, outside the strict indication for antibiotics. Methods: A total of 220 patients with acute bronchitis were randomized and given either verum containing EPs 7630 (1-6 years/> 6-12 years/> 12-18 years: 3 10/3 20/3 30 drops/day) or matching placebo for 7 days. The main outcome measure was the change in the total score of bronchitis-specific symptoms (BSS) from day 0 to day 7. Results: The decrease in the BSS total score was significantly higher for EPs 7630 compared to placebo (change day 0-day 7: 4.4 1 1.6 vs 2.9 1 1.4 points; P < 0.0001). Improvements were most pronounced for 'coughing' and 'rales at auscultation'. Tolerability was similarly good in both groups. Conclusions: EPs 7630 proved to be an efficacious and well-tolerated option for the treatment of acute bronchitis in children and adolescents outside the strict indication for antibiotics.