Suitability of ivy extract for the treatment of paediatric cough.
- 2012-04-25
- Phytotherapy research : PTR 26(12)
- M Schmidt
- M Thomsen
- U Schmidt
- PubMed: 22532491
- DOI: 10.1002/ptr.4671
Study Design
- Type
- Clinical Trial
- Population
- 268 children aged 0-12 yr
- Methods
- Two open, non-interventional studies with identical design; 268 children treated with syrup or cough drops for up to 14 days; effects on cough-related symptoms assessed on a verbal rating scale
- Blinding
- Open-label
- Duration
- up to 14 days
- Funding
- Unclear
Two galenical formulations of an ivy herbal extract, syrup and cough drops, were tested for their efficacy and safety in the paediatric treatment of cough and bronchitis in two independent open, non-interventional studies with identical design. Two-hundred and sixty-eight children aged 0-12 yr were treated with one of the two preparations for up to 14 days. The effects on cough-related symptoms were addressed on a verbal rating scale. At the end of the study the major symptoms rhinitis, cough and viscous mucus, were found to be only mildly expressed or absent in 93, 94.2 and 97.7% of cases. The global effect was rated as 'good' or 'very good' in 96.5% of cases. Tolerability and compliance were found 'good' to 'very good' in 99% (syrup) and 100% (drops) of patients on completion of the study. A subgroup analysis according to four different age and dosing groups did not reveal differences in treatment response. Safety was confirmed and corresponded to literature findings. Five adverse events classified as mild and non-serious were reported (1.9%). In conclusion, ivy leaf extract in the form of syrup and of cough drops was confirmed as an effective and safe treatment of cough in children.
Research Insights
At the end of the study the major symptoms rhinitis, cough and viscous mucus, were found to be only mildly expressed or absent in 93, 94.2 and 97.7% of cases.
- Effect
- Beneficial
- Effect size
- Large
- Dose
- up to 14 days
At the end of the study the major symptoms rhinitis, cough and viscous mucus, were found to be only mildly expressed or absent in 93, 94.2 and 97.7% of cases.
- Effect
- Beneficial
- Effect size
- Large
- Dose
- up to 14 days
At the end of the study the major symptoms rhinitis, cough and viscous mucus, were found to be only mildly expressed or absent in 93, 94.2 and 97.7% of cases.
- Effect
- Beneficial
- Effect size
- Large
- Dose
- up to 14 days
Adverse Events Reported
Tolerability and compliance were found 'good' to 'very good' in 99% (syrup) and 100% (drops) of patients on completion of the study.
- Finding
- Reported
Five adverse events classified as mild and non-serious were reported (1.9%).
- Finding
- Reported
- Grade
- mild