Topical symphytum herb concentrate cream against myalgia: a randomized controlled double-blind clinical study
Abstrakt
The effectiveness and tolerability of the topical Symphytum product Traumaplant(R) (Harras Pharma Curarina, Munchen, 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<5x10(-9)), pain at rest (P<.001), and pain on palpation (P=5x10(-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=4x10(-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.