Escin/diethylammonium salicylate/heparin combination gels for the topical treatment of acute impact injuries: a randomized, double blind, placebo controlled, multi-center study

D. Wetzel, W. Menke, R. Dieter, V. Smasal, B. Giannetti, and M. Bulitta

British Journal of Sports Medicine 2002; 36:183-188

This study investigated the clinical efficacy and safety of escin-containing gels in the topical treatment of blunt impact injuries.

Competitors in soccer, handball, or karate competitions were enrolled within two hours of sustaining a strain, sprain, or contusion and treated three times with the trial gel within a period of eight hours. Patients were randomized to three parallel groups consisting of two active treatment gels, containing escin (1% or 2%), 5% diethylammonium salicylate, and 5000 IU heparin, or placebo gel. Tenderness produced by pressure was measured at 0 (baseline), 1, 2, 3, 4, 6, and 24 hours after enrolment (within two hours of the injury). Tenderness was defined as the amount of pressure (measured by a calibrated caliper at the centre of the injury) that first produced a pain reaction as reported by the patient.

A total of 158 patients were enrolled; 156 were evaluated in the intention to treat analysis. The primary efficacy variable was the area under the curve for tenderness over a six-hour period. The gel preparations containing 1% and 2% escin were significantly more effective than placebo. The time to reach resolution of pain at the injured site was shorter in the treatment groups than in the placebo group. Both active gel preparations produced more rapid pain relief than the placebo gel. No relevant differences were detected between the two active gels. The safety and tolerability of the escin-containing gels were excellent.

Conclusions. scin/diethylammonium salicylate/heparin combination gel preparations are effective and safe for the treatment of blunt impact injuries.