Objective: Efficacy and safety of an oral thyme/ivy syrup for the treatment of acute cough was previously demonstrated in a randomized clinical trial. Here, we present real-life data from a pharmacy-based, observational study on the effectiveness and tolerability of another thyme/ivy combination (BNO 1200, Bronchipret drops).
Methods: This observational, prospective, uncontrolled study was conducted in 305 German pharmacies. Cough and associated symptoms, cough severity and health related quality of life (HRQoL) were assessed at baseline, after 4 days and at individual end of treatment (EoT) in patients with acute cough due to upper respiratory tract infections who bought BNO 1200. Patients took BNO 1200 until resolution of cough and completed three validated questionnaires: patient-adapted Bronchitis Severity Score (BSS), cough severity visual analogue scale (VAS) and the Leicester Cough Questionnaire (LCQ-acute). They also rated speed of onset of treatment action on a VAS and tolerability.
Results: A total of 749 patients participated in the study; 730 were included in the analysis. Mean treatment duration was 7.0 ± 3.6 days. Symptom severity assessed by BSS improved from 8.7 ± 3.8 score points (baseline) to 2.4 ± 2.6 at EoT (p < .0001). Clinically relevant improvements (MCID = 17 mm) in cough severity were reported by 87.2% of patients at EoT. HRQoL improved significantly (12.2 ± 3.3 points at baseline vs. 18.5 ± 2.7 at EoT; p < .0001), exceeding the MCID (=2 points) in 90.0% of patients. Tolerability was rated "good" or "very good" by 98.0% of patients. No adverse drug reactions were reported.
Conclusion: Patients with acute cough taking BNO 1200 had a significant reduction in BSS, cough severity and improvement in HRQoL confirming RCT data with the syrup formulation. BNO 1200 was well tolerated.
Keywords: Bronchitis; antitussive; cough; observational study; plant-based.