Open trial to assess aspects of safety and efficacy of a combined herbal cough syrup with ivy and thyme.

Abstract

Background and objectives: Changes in the symptoms of cough after treatment with a combined herbal preparation containing dry ivy leaf extract as main active ingredient, decoction of thyme and aniseed, and mucilage of marshmallow root (Weleda Hustenelixier, new formulation) and its tolerability were investigated in an open clinical trial ('Anwendungsbeleg').

Patients and methods: Between January and March 2004, 13 general practitioners recruited and treated 62 patients with a mean age of 50 years (range 16-89). The patients had irritating cough in consequence of common cold (n = 29), bronchitis (n = 20) or respiratory tract diseases with formation of viscous mucus (n = 15). The mean daily intake was 10 ml (range 7.5-15) of syrup, and the mean duration of treatment was 12 days (range 3-23 days). Treatment results were assessed on the basis of changes in the symptom scores for cough and expectoration. Safety was evaluated by means of an analysis of adverse events. In addition, efficacy and tolerability were analyzed from the judgments of the doctors and patients.

Results: At the final visit, all symptom scores showed an improvement as compared to baseline. Doctors and patients assessed efficacy as good or very good in 86% and 90% of the cases, respectively. Tolerability was assessed as good or very good by 97% of the doctors and patients. Only one adverse event was reported. However, a relation to the medication was classified to be unlikely.

Conclusion: Considering the traditional use of ivy leaves, thyme herb, aniseed and marshmallow root in preparations for cough, the reduction in the symptom score as well as the good tolerability the investigated combined herbal cough syrup seems to alleviate cough in consequence of common cold, bronchitis or respiratory tract diseases with formation of mucus.