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.