Acute bronchitis therapy with ivy leaves extracts in a two-arm study: A double-blind, randomised study vs. an other ivy leaves extract
Abstrakt
Ivy leaves extracts are authorised in medicinal products for the treatment of acute bronchitis. Different studies and the long experience on the market show safety and efficacy of this drug.
A double-blind, randomised study was conducted to assess the efficacy and tolerability of ivy leaves soft extract with an other ivy leaves extract. 590 patients with acute bronchitis participated in this study. They were treated with test or comparator for 7 days (+/-1).
The Bronchitis Severity Score (BSS) decreased gradually and to a similar extent from Day 1 to Day 7 in both treatment groups. Starting from values of 6.2-6.3 +/- 1.2, the BSS decreased by approximately 4.7-4.9 points until Day 7, so that patients left the study with a mean BSS of 1.4-1.6.
The BSS subscales cough, sputum, rhales/rhonchi, chest pain during coughing, and dyspnoea improved to a similar extent in both treatment groups. Overall, 2.7% of patients (per group and overall) experienced an adverse event, all of which were non-serious.
Fewer patients younger than ten years had adverse events than would have been expected from their share of the study population (p = 0.015; Fisher's exact test). As a conclusion, the test product with ivy leaves soft extract proved to be non-inferior to the comparator ivy leaves extract in improving symptoms of acute bronchitis.