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.