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

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.

Arnica/Hydroxyethyl salicylate combination spray for ankle distortion: a four-arm randomised double-blind study.

570 patients with acute ankle joint distortion were randomized to four treatment groups: a combination spray of arnica tincture and hydroxyethyl salicylate (HES; group A, n = 228), arnica (B, n = 57), HES (C, n = 228), and placebo (D, n = 57). The medication was applied 4-5 times daily for 10 days. Efficacy was assessed on day 3-4 by evaluating pain on motion on a visual analogue scale (VAS). Pain improvement in group A was significantly superior over groups B-D (t-test with unadjusted baseline values, P < 4 × 10(-7) and ANCOVA after adjustment, P < 5 × 10(-11)) and approximately corresponded to the cumulative effect of the single constituents (12.1, 7.5, and 18.7 mm VAS for A versus B, A versus C, and A versus D; 95% CI 8.0-16.2, 4.7-10.4, and 14.8-22.5 mm). The combination is justified by the additive effects of the single active constituents.

[Wound healing effects of a Symphytum herb extract cream (Symphytum x uplandicum NYMAN: ): results of a randomized, controlled double-blind study]. / Der wundheilende Effekt einer Symphytum-Herba-Extrakt-Creme (Symphytum x uplandicum Nyman): Ergebnisse einer randomisierten, kontrollierten Doppelblindstudie.

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.

Topical symphytum herb concentrate cream against myalgia: a randomized controlled double-blind clinical study.

The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (P<5 x 10 -9 ), pain at rest (P<.001), and pain on palpation (P=5 x 10 -5 ) was significantly more pronounced than that attained with the reference product and was clinically highly relevant. A number needed to treat of 3.2 was calculated from the study results. Global efficacy was significantly better (P=1 x 10 -8 ) and onset of effects was faster (P=4 x 10 -7 ) with the high-concentration product. Tolerability of the highly concentrated study product was good to excellent in all patients. Study results confirm the known anti-inflammatory and analgesic effects of topical (Symphytum cream. As a new finding, applicability in certain forms of back pain can be concluded.

Efficacy and safety of topically applied Symphytum herb extract cream in the treatment of ankle distortion: results of a randomized controlled clinical double blind study.

In a controlled, double blind, randomized multicentre study, the efficacy and safety of the topical comfrey product Traumaplant (10% active ingredient of a 2.5:1 aqueous ethanolic pressed juice of freshly harvested, cultivated comfrey herb (Symphytum x uplandicum NYMAN), corresponding to 25 g of fresh herb per 100 g of cream; n = 104) was tested against a 1% product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n = 99) in 203 patients with acute ankle distortion. With the high concentration, decrease of the scores for pain on active motion, pain at rest and functional impairment was highly significant and clinically relevant on days T3-4 as well as T7 (p < 0.001). Amelioration of swellings as compared to reference was also significant on day 3-4 (p < 0.01). Efficacy was judged good to excellent in 85.6% of cases with verum and in 65.7% of cases with reference on day 3-4. Overall tolerability was excellent.