Randomized Double-Blind Study: Wound-Healing Effects of a Symphytum Herb Extract Cream (Symphytum×uplandicum Nyman) in Children

 

 Buy Article Permissions and Reprints

Abstract

The wound healing effects of the topically applied preparation Traumaplant^® containing a concentrate (10% active ingredient) from the aerial parts of medicinal comfrey (Symphytum × uplandicum Nyman) were examined in a randomized, controlled, clinical double-blind study. An otherwise identical low-dose preparation (1% active ingredient) was used as a control. The study population consisted of 108 children aged 3–12 years (n=54/group) with fresh abrasions. A 50% healing rate was reached 0.9 days earlier with the higher than with the lower concentration cream. The difference in the healing rate (0.38±0.18/day [95% CI 0.33–0.4] vs. 0.26±0.14/day [95% CI 0.222–0.297]) was statistically significant (p=0.0002). Physicians and children/parents both rated the efficacy of the 10% cream as significantly better than that of the control preparation (physicians’ assessment after 2–3 and 7–9 days for verum vs. control: 90.7 and 92.6% vs. 55.6 and 74.0% of the healing rates were rated as ”good“ or “very good“, respectively; p=0.0004 and 0.01). In subgroup analyses, there was no significant influence on the healing rate of the time elapsed between the accident and the first consultation, the wound surface, the affected body part, the origin of the injury and gender. There were no reported adverse effects or problems with tolerability such as local skin irritations. The results justify application of the Symphytum herb extract cream in children with blunt traumata with or without abrasions.

• References

• 1 D’Anchise R, Bulitta M, Giannetti B. Comfrey extract ointment in comparison to diclofenac gel in the treatment of acute unilateral ankle sprains (distortions). Arzneimittelforschung 2007; 57: 712-716
  Article in Thieme ConnectPubMedGoogle Scholar
• 2 Predel HG, Giannetti B, Koll R et al. Efficacy of a comfrey root extract ointment in comparison to a diclofenac gel in the treatment of ankle distortions: results of an observer-blind, randomized, multicenter study. Phytomedicine 2005; 12: 707-714
  CrossrefPubMedGoogle Scholar
• 3 Koll R, Buhr M, Dieter R et al. Efficacy and tolerance of a comfrey root extract (Extr. Rad. Symphyti) in the treatment of ankle distorsions: results of a multicenter, randomized, placebo-controlled, double-blind study. Phytomedicine. 2004. 11. 470-477
  Google Scholar
• 4 Hess H. Wirkung einer Symphytum-Salbe bei Sportverletzungen des Kniegelenks. Dtsch Z Sportmed 1991; 42: 156-162
  PubMedGoogle Scholar
• 5 Kucera M, Kalal J, Polesna Z. Effects of Symphytum ointment on muscular symptoms and functional locomotor disturbances. Adv Ther 2000; 17: 204-210
  CrossrefPubMedGoogle Scholar
• 6 Kucera M, Barna M, Horacek O et al. 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. Wien Med Wochenschr 2004; 154: 498-507
  CrossrefPubMedGoogle Scholar
• 7 Mayer G. Die Lokalbehandlung der akuten lateralen Distorsion des oberen Sprunggelenkes mit einer Symphytum-Wirkstoffkomplexsalbe. Acta Ther 1991; 17: 89-100
  PubMedGoogle Scholar
• 8 Mayer G. Die Lokalbehandlung von Kontusionen und Distorsionen des Kniegelenkes mit einer Symphytum-Wirkstoffkomplex-Salbe. Erfahrungsheilkunde 1992; 41: 888-891
  PubMedGoogle Scholar
• 9 Schmidt M. Hochleistungssorte ´Harras´ als Beitrag zu Qualität, Wirksamkeit und Sicherheit von Beinwell (Symphytum x uplandicum Nyman). Z Arznei-Gewurzpfla 2008; 13: 182-184
  PubMedGoogle Scholar
• 10 Grünwald J, Bitterlich N, Nauert C et al. Anwendung und Verträglichkeit von Beinwellcreme (Symphyti herba) bei Kindern mit akuten stumpfen Traumen. Z Phytother 2010; 31: 61-65
  Article in Thieme ConnectPubMedGoogle Scholar
• 11 Schmidt M. Symphytum. Effizienz auch bei Kindern belegt. Naturamed 2011; 26: 36-39
  PubMedGoogle Scholar
• 12 Niedner R. Beeinflussung der Epithelialisierung durch einen Wirkstoffkomplex aus Symphytum. Acta Ther 1989; 15: 289-297
  PubMedGoogle Scholar
• 13 Barna M, Kucera A, Hladicova M et al. Der wundheilende Effekt einer Symphytum-Herbaextraktcreme (Symphytum x uplandicum Nyman): Ergebnisse einer randomisierten, kontrollierten Doppelblindstudie. Wien Med Wochenschr 2007; 157: 569-574
  CrossrefPubMedGoogle Scholar
• 14 Sachs L. Applied Statistics. A Handbook of Techniques. 2nd Ed Berlin: Springer-Verlag; 1984. 440.
  Google Scholar
• 15 Jessup RL. What is the best method for assessing the rate of wound healing? A comparison of 3 mathematical formulas. Adv Skin Wound Care 2006; 19: 138-147
  CrossrefPubMedGoogle Scholar
• 16 Gilman TH. Parameter for measurement of wound closure. Wounds 1990; 3: 95-101
  PubMedGoogle Scholar
• 17 Snowden JM. Wound closure: an analysis of the relative contributions of contraction and epithelialization. J Surg Res 1984; 37: 453-463
  CrossrefPubMedGoogle Scholar
• 18 Kucera M, Barna M, Horacek O et al. Topical Symphytum herb concentrate cream against myalgia: a randomized controlled double-blind clinical study. Adv Ther 2005; 22: 681-692
  CrossrefPubMedGoogle Scholar
• 19 Kucera M, Stepan J, Kolar P. Traumaplant Anwendung beim Heilungsvorgang von Decubitusdefekten. Medicina Sportiva Boh Slov 2007; 16: 26-32
  PubMedGoogle Scholar
• 20 Mayer G. Die Lokalbehandlung des akuten Supraspinatussehnen-Syndroms mit einer Symphytum-Wirkstoffkomplex-Salbe. Dtsch Z Sportmed 1993; 44: 121-124
  PubMedGoogle Scholar