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.
Kucera
Miroslav
M
Department of Sports Medicine and Rehabilitation, 2nd Medical Faculty, Charles University in Prague, Czech Republic.
Barna
Milos
M
Horàcek
Ondrej
O
Kàlal
Jan
J
Kucera
Alexander
A
Hladìkova
Marie
M
D000328:Adult; D001416:Back Pain / Q000628:therapy*; D020844:Comfrey; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009038:Motion; D010147:Pain Measurement; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*
D028321:Plant Preparations