Tolerability and effectiveness of an antitrauma cream with comfrey herb extract in pediatric use with application on intact and on broken skin

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11130%2F18%3A10393655" target="_blank" >RIV/00216208:11130/18:10393655 - isvavai.cz</a>

Alternative codes found

RIV/00064203:_____/18:10393655

Result on the web

<a href="https://doi.org/10.1016/j.ijpam.2018.11.002" target="_blank" >https://doi.org/10.1016/j.ijpam.2018.11.002</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.ijpam.2018.11.002" target="_blank" >10.1016/j.ijpam.2018.11.002</a>

Result language

angličtina

Original language name

Tolerability and effectiveness of an antitrauma cream with comfrey herb extract in pediatric use with application on intact and on broken skin

Original language description

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.

Czech name

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Czech description

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Type

J_ost - Miscellaneous article in a specialist periodical

CEP classification

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OECD FORD branch

30209 - Paediatrics

Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2018

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

International Journal of Pediatrics and Adolescent Medicine

ISSN

2352-6467

e-ISSN

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Volume of the periodical

5

Issue of the periodical within the volume

4

Country of publishing house

SA - THE KINGDOM OF SAUDI ARABIA

Number of pages

7

Pages from-to

135-141

UT code for WoS article

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EID of the result in the Scopus database

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