Anwendung und VertrÃ¤glichkeit von Beinwellcreme (Symphyti herba) bei Kindern mit akuten stumpfen Traumen

Grünwald, J.; Bitterlich, Norman; Nauert, C; Schmidt, Mathias

doi:10.1055/s-0030-1247646

Cited by 6 publications

(9 citation statements)

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“…The practical applicability of the same preparation as used in the two observational studies presented herein was already demonstrated in children in observational studies with blunt traumas [16] and in randomized clinical double-blind trials [13,14]. The number of children exposed to the study preparation described in the literature adds up to 529 patients.…”

Section: Discussionmentioning

confidence: 88%

“…The benefits of the comfrey cream in pediatric use were examined in observational studies including 361 children with blunt traumas [16,17] and in a clinical double-blind trial with 108 children treated for fresh abrasions [14]. The currently available data support an excellent tolerability and efficacy of the comfrey cream formulation used in these trials, including the application in children and adolescents.…”

Section: Introductionmentioning

confidence: 99%

“…For the age group of children between 4 and 12 years, the documented exposure in interventional and noninterventional clinical trials accumulates to approximately 520 patients treated for blunt traumas and abrasions [13,14,16]. The number of children treated to date would statistically translate into the conclusion of any given adverse effect being unlikely to be observed in approximately 1.5 out of 100 children with intact skin and, due to the smaller documented case numbers, in approximately 2 out of 100 cases with broken skin.…”

Section: Introductionmentioning

confidence: 99%

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

Kucera

Barna²,

Holcova³

et al. 2018

International Journal of Pediatrics and Adolescent Medicine

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ObjectiveThe 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.MethodsA 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.ResultsNo 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.ConclusionThese 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.

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Section: Discussionmentioning

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Kucera

Barna²,

Holcova³

et al. 2018

International Journal of Pediatrics and Adolescent Medicine

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“…A clear improvement, ranging from 84.5% to 100% was found for every individual parameter, such as pain on palpitation, pain in motion, functional impairment, edema and hematoma. Concomitantly, excellent tolerability and compliance were observed [160]. Later, the data from this non-interventional study were confirmed and extended with a randomized, controlled, double-blind clinical trial, composed of 108 children, from three to 12 years ( n = 54/group) with fresh abrasions [161].…”

Section: Clinical Effectiveness Of Symphytum Species In Humansmentioning

confidence: 81%

Symphytum Species: A Comprehensive Review on Chemical Composition, Food Applications and Phytopharmacology

et al. 2019

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Symphytum species belongs to the Boraginaceae family and have been used for centuries for bone breakages, sprains and rheumatism, liver problems, gastritis, ulcers, skin problems, joint pain and contusions, wounds, gout, hematomas and thrombophlebitis. Considering the innumerable potentialities of the Symphytum species and their widespread use in the world, it is extremely important to provide data compiling the available literature to identify the areas of intense research and the main gaps in order to design future studies. The present review aims at summarizing the main data on the therapeutic indications of the Symphytum species based on the current evidence, also emphasizing data on both the efficacy and adverse effects. The present review was carried out by consulting PubMed (Medline), Web of Science, Embase, Scopus, Cochrane Database, Science Direct and Google Scholar (as a search engine) databases to retrieve the most updated articles on this topic. All articles were carefully analyzed by the authors to assess their strengths and weaknesses, and to select the most useful ones for the purpose of review, prioritizing articles published from 1956 to 2018. The pharmacological effects of the Symphytum species are attributed to several chemical compounds, among them allantoin, phenolic compounds, glycopeptides, polysaccharides and some toxic pyrrolizidine alkaloids. Not less important to highlight are the risks associated with its use. In fact, there is increasing consumption of over-the-counter drugs, which when associated with conventional drugs can cause serious and even fatal adverse events. Although clinical trials sustain the folk topical application of Symphytum species in musculoskeletal and blunt injuries, with minor adverse effects, its antimicrobial potency was still poorly investigated. Further studies are needed to assess the antimicrobial spectrum of Symphytum species and to characterize the active molecules both in vitro and in vivo.

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“…In an open observational study the above mentioned topical cream was tested in 196 children from the ages of 4 to 12 yr with respect to the paediatric treatment of acute blunt traumata (contusions, strains and distortions; Grünwald et al ., 2010 ). The symptoms pain on palpitation, pain in motion, functional impairment, oedema and haematoma were included in the evaluation.…”

Section: Other Clinical Studies and Post-marketing Surveillancementioning

confidence: 99%

Comfrey: A Clinical Overview

Staiger

2012

Phytotherapy Research

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Comfrey has a centuries-old tradition as a medicinal plant. Today, multiple randomized controlled trials have demonstrated the efficacy and safety of comfrey preparations for the topical treatment of pain, inflammation and swelling of muscles and joints in degenerative arthritis, acute myalgia in the back, sprains, contusions and strains after sports injuries and accidents, also in children aged 3 or 4 and over. This paper provides information on clinical trials and non-interventional studies published on comfrey to date and further literature, substantiating the fact that topical comfrey preparations are a valuable therapy option for the treatment of painful muscle and joint complaints. Copyright © 2012 John Wiley & Sons, Ltd.

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Anwendung und VertrÃ¤glichkeit von Beinwellcreme (Symphyti herba) bei Kindern mit akuten stumpfen Traumen

Cited by 6 publications

References 0 publications

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

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

Symphytum Species: A Comprehensive Review on Chemical Composition, Food Applications and Phytopharmacology

Comfrey: A Clinical Overview

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