Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2006; 11: 14–5
To investigate the efficacy and tolerability of a fluid extract combination of thyme and ivy leaves (TIC) in patients with acute bronchitis.
In a double-blind, placebo-controlled study 361 outpatients with acute bronchitis [≥10 coughing fits/day, bronchial mucus production for ≤2 days prior to recruitment, Bronchitis Severity Score (BSS) ≥5] were assigned to an 11-day treatment (5.4 ml t.i.d.) with TIC (Bronchipret Saft) (n = 182) or placebo (n = 179). After visit 1 (day 0), control visits were scheduled on days 4 and 10. Efficacy was assessed by patient’s daily counting of coughing fits/day (manual counter) documented in a diary, assessment of disease-related symptoms and BSS. Tolerability was evaluated on adverse effect (AE) monitoring and measurement of vital signs. Primary outcome was the change in frequency of coughing fits during days 7–9.
The mean reduction in coughing fits on days 7–9 relative to baseline was 68.7% under TIC compared to 47.6% under placebo (P < 0.0001). Under TIC a 50% reduction in coughing fits from baseline was reached 2 days earlier. BSS improved rapidly in both groups, but regression of symptoms was faster and responder rates (P < 0.0001) were higher on day 4 (83.0 vs. 53.9%) and day 10 (96.2 vs. 74.7%) under TIC. No severe/serious AEs were reported and the frequency and severity of AEs were within the same range for TIC and placebo.
Treatment with TIC was superior to placebo in terms of efficacy and well tolerated.
The trial was funded by Bionorica AG, Neumarkt, Germany.
