OBJECTIVE: The safety of comfrey herbal cream application to broken skin is still a matter of regulatory debate. It was therefore examined in children with intact and with broken skin treated for blunt traumas and sports injuries, with the aim of collecting data for pharmacovigilance and clinical safety assessments. METHODS: A total of 712 children (386 children with intact skin and 326 children with abrasions and superficial wounds) were openly treated for up to 2 weeks with 1-5 applications daily of comfrey herb cream after presenting for blunt traumas and sports accidents. The incidence rate of adverse events was calculated, next to a global assessment of treatment effects. RESULTS: No adverse events occurred in the group of children with intact skin, and one intolerability reaction (burning and reddening) was observed after application to broken skin. The overall incidence rate of intolerability reactions per patient was calculated as 0.14% (95% CI 0.00-0.78%) and that of systemic adverse effects as 0.00% (95% CI 0.00-0.42%). Accordingly, the probability of the occurrence of local reactions and systemic adverse events is well below, which is one in 100 treated patients. The global assessment of effects corresponded to previously published experience. CONCLUSION: These studies confirm an excellent benefit-to-risk ratio for the application of comfrey herb cream in the treatment of blunt traumas and sports injuries in children with intact and with broken skin.

2nd Medical Faculty of the Charles University 5 Úvalu 84 15006 Prague 5 Czech Republic

Department of Medical Informatics 2nd Faculty of Medicine Charles University of Prague 5 Úvalu 84 CZ 15006 Prague 5 Czech Republic

Ordination for Rehabilitation Marakova 3 263 16000 Prague 6 Czech Republic

Ottillinger Life Sciences Foehrenstrasse 12 D 85649 Brunnthal Hofolding Germany

Outpatient Department of Dermatovenerology Jugoslávská 13 CZ 61300 Brno 2 Czech Republic

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