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

Pediatr Int. 2012 Apr;54(2):219-26. doi: 10.1111/j.1442-200X.2012.03598.x.

Abstract

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 ± 1.6 vs 2.9 ± 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Bronchitis / drug therapy*
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Health Status
  • Humans
  • Male
  • Phytotherapy*
  • Plant Extracts / therapeutic use*
  • Quality of Life
  • Treatment Outcome

Substances

  • EPs 7630
  • Plant Extracts