Der wundheilende Effekt einer Symphytum-Herba-Extrakt-Creme (Symphytum x uplandicum Nyman): Ergebnisse einer randomisierten, kontrollierten Doppelblindstudie
[Wound healing effects of a Symphytum herb extract cream (Symphytum x uplandicum NYMAN: ): results of a randomized, controlled double-blind study]
Language German Country Austria Media print
Document type Clinical Trial, Phase IV, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial
- MeSH
- Child MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Phytotherapy * MeSH
- Wound Healing drug effects MeSH
- Comfrey * MeSH
- Skin injuries MeSH
- Middle Aged MeSH
- Humans MeSH
- Ointments MeSH
- Pain Measurement MeSH
- Adolescent MeSH
- Child, Preschool MeSH
- Prospective Studies MeSH
- Plant Extracts therapeutic use MeSH
- Aged MeSH
- Athletic Injuries drug therapy MeSH
- Check Tag
- Child MeSH
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Male MeSH
- Child, Preschool MeSH
- Aged MeSH
- Female MeSH
- Publication type
- English Abstract MeSH
- Journal Article MeSH
- Clinical Trial, Phase IV MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Ointments MeSH
- Plant Extracts MeSH
- Traumaplant MeSH Browser
METHOD: Wound healing effects of a topically applied preparation (Traumaplant) containing a concentrate (10 % active ingredient) from the aerial parts of medicinal comfrey (Symphytum x uplandicum NYMAN: ) were examined in a randomized clinical double-blind study including 278 patients with fresh abrasions (verum: n = 137), among them 64 patients of up to 20 years of age (verum n = 29, reference product n = 35). An otherwise identical low-dose preparation (1 % active ingredient; n = 141) was used as a reference. RESULTS: After 2-3 days of application of the study medication a highly significantly and clinically relevantly faster initial reduction of wound size of 49 + or - 19 % versus 29 + or - 13 % per day in favour of verum (p < 5x10(-21)) was found. From linear regression time to complete healing was determined to be 2.97 days faster with verum than with reference (4.08 vs. 7.05 days, p = 7.4 x 10(-45) in the t-Test comparison of regression lines). The physicians rated efficacy as good to very good in 93.4 % of cases, as compared to 61.7 % in the group treated with the reference product (p = 2 x 10(-11)). On a scale of 0-100 verum was rated with 84.4 + or - 10.1 points by the patients themselves. The reference product was rated with 65.5 + or - 24.8 points (p = 6.1 x 10(-18)). In subgroup analyses no significant influence of abrasion area, gender and age on healing effects was found, albeit a tendency towards better effects with increasing age was observed. No adverse effects or problems with drug tolerability occurred. Specifically, cutaneous reactions were observed in none of the patients throughout the 10 day observation phase. CONCLUSIONS: Symphytum herb extract can be attributed distinct wound healing effects, effects that can explicitly be used in paediatry.
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