title: 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.
abstract: 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.
authors.affiliation: Department for Sports Medicine and Rehabilitation, 2nd Medical Faculty of the Charles University Prague, Prague. miroslav.kucera@lfmotol.cuni.cz
authors.forename: Miroslav
authors.initials: M
authors.lastname: Kucera
authors.forename: Milos
authors.initials: M
authors.lastname: Barna
authors.forename: Ondrej
authors.initials: O
authors.lastname: Horácek
authors.forename: Jaroslava
authors.initials: J
authors.lastname: Kováriková
authors.forename: Alexander
authors.initials: A
authors.lastname: Kucera
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D016512:Ankle Injuries / Q000188:drug therapy*; D020844:Comfrey; D004311:Double-Blind Method; D004487:Edema / Q000188:drug therapy; D005260:Female; D006801:Humans; D004204:Joint Dislocations / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts