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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.

Arnica/Hydroxyethyl Salicylate Combination Spray for Ankle Distortion: A Four-Arm Randomised Double-Blind Study