Treatment of acute bronchitis with EPs 7630: randomized, controlled trial in children and adolescents.
Study Design
- Study Type
- Randomized Controlled Trial
- Sample Size
- 220
- Population
- Children and adolescents with acute bronchitis
- Duration
- 1 weeks
- Intervention
- Treatment of acute bronchitis with EPs 7630: randomized, controlled trial in children and adolescents. 3x10-30 drops/day (age-adjusted)
- Comparator
- Placebo drops
- Primary Outcome
- Bronchitis Severity Score (BSS) change
- Effect Direction
- Positive
- Risk of Bias
- Low
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.
TL;DR
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.
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