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 ofcough after treatment with a combined herbal preparationcontaining dry ivy leaf extract as main active ingredient, decoctionof thyme and aniseed, and mucilage of marshmallowroot (Weleda Hustenelixier, new formulation) and its tolerabilitywere investigated in an open clinical trial (‘Anwendungsbeleg’).Patients and Methods: Between January andMarch 2004, 13 general practitioners recruited and treated62 patients with a mean age of 50 years (range 16-89). Thepatients had irritating cough in consequence of commoncold (n = 29), bronchitis (n = 20) or respiratory tract diseaseswith formation of viscous mucus (n = 15). The mean dailyintake was 10 ml (range 7.5-15) of syrup, and the mean durationof treatment was 12 days (range 3-23 days). Treatmentresults were assessed on the basis of changes in thesymptom scores for cough and expectoration. Safety wasevaluated by means of an analysis of adverse events. In addition,efficacy and tolerability were analyzed from the judgmentsof the doctors and patients. Results: At the final visit,all symptom scores showed an improvement as comparedto baseline. Doctors and patients assessed efficacy as goodor very good in 86% and 90% of the cases, respectively. Tolerabilitywas assessed as good or very good by 97% of thedoctors and patients. Only one adverse event was reported.However, a relation to the medication was classified to beunlikely. Conclusion: Considering the traditional use of ivyleaves, thyme herb, aniseed and marshmallow root inpreparations for cough, the reduction in the symptom scoreas well as the good tolerability the investigated combinedherbal cough syrup seems to alleviate cough in consequenceof common cold, bronchitis or respiratory tract diseaseswith formation of mucus.