Escin/diethylammonium salicylate/heparin combination gels for the topical treatment of acute impact injuries: a randomised, double blind, placebo controlled, multicentre study
- 1Research and Development, Madaus AG, Cologne, Germany
- 2Deutsche Sporthochschule, Cologne
- 3Orthopaedic Surgery, Fütererstr 21, Munich, Germany
- 4Orthopaedic Surgery, Hohenzollernstr 88, Munich, Germany
- 5CRM GmbH, Rheinbach, Germany
- Correspondence to: Mr Bulitta, CRM GmbH, Weiherstr 19, D-53359 Rheinbach, Germany;
- Accepted 6 December 2001
Objectives: To investigate the clinical efficacy and safety of escin-containing gels in the topical treatment of blunt impact injuries.
Methods: 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 randomised 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.
Results: 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 (a priori ordered hypotheses testing controlling the multiple α = 5% significance level) than placebo (p1 = 0.0001 and p2 = 0.0002 respectively). The treatment effects were 5.7 kp h/cm2 (95% confidence interval (CI) 2.9 to 8.5) and 5.9 kilopond (kp) h/cm2 (95% CI 2.9 to 8.8) between 1% escin and placebo and between 2% escin and placebo respectively. These results were supported by secondary efficacy variables. The time to reach the baseline contralateral tenderness value (resolution of pain) at the injured site was shorter in the treatment groups than in the placebo group (p<0.0001). 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: Escin/diethylammonium salicylate/heparin combination gel preparations are effective and safe for the treatment of blunt impact injuries.
- topical treatment
- escin/diethylammonium salicylate/heparin combination gel
- DEAS, diethylammonium salicylate
- AUC, area under the curve
- ITT, intention to treat
- PP, per protocol
- kp, kilopond (1 kp = 9.80665 N)