Abstract
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.
Highlights
A combination product with arnica tincture and hydroxyethyl salicylate (HES) as active constituents in the galenical formulation of a spray registered as a medicinal product has a long history of clinical use in ankle joint distortion in Germany and the Czech Republic, there is little published clinical evidence from trials [1]
The study results indicated a superiority of the combination over the two single constituents
A sample size calculation was made based on observations from a clinical pharmacology study [11], where the increase of pain threshold was measured separately for the combination and its single constituents versus activesubstance-free control by using transcutaneous electric nerve stimulation (TENS)
Summary
A combination product with arnica tincture (aqueousethanolic extract from the flowers of Arnica montana) and hydroxyethyl salicylate (HES) as active constituents in the galenical formulation of a spray registered as a medicinal product has a long history of clinical use in ankle joint distortion in Germany and the Czech Republic, there is little published clinical evidence from trials [1]. The local analgesic effects of the combination spray with arnica tincture and HES have been shown efficacious in a pharmacodynamic proof of concept trial in healthy volunteers using transcutaneous electric nerve stimulation for the assessment of pain threshold [11]. The present study has a similar design but is performed as a confirmatory clinical trial in patients. It had a twofold aim: to demonstrate the efficacy and tolerability of the combination spray against ankle joint distortion under randomized double-blind conditions versus placebo and to provide details on the contribution to efficacy of the single constituents. It was hypothesized that the effect of the combination is superior over the effect of HES or that of arnica tincture when applied as a monopreparation
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