Efficacy and tolerability of escin/diethylamine salicylate combination gels in patients with blunt injuries of the extremities.
The aim of this confirmative, monocentre, double-blind, controlled clinical trial was to investigate whether different escin combinations show differences in comparison to placebo with regard to pain reactions in the topical treatment of sports injuries. A total of 126 patients with blunt injuries of the extremities were randomly allocated to four parallel groups: Reparil-Gel N (n = 32), Reparil-Gel (n = 31), Reparil-Sportgel (n = 32) and a placebo gel (n = 31). All patients were evaluated for efficacy (intention to treat) and tolerability. A per-protocol analysis was also carried out, in which 12 of the 126 patients were excluded due to protocol violations. The intention-to-treat and per-protocol analyses produced similar results. The patients had suffered contusions while participating in soccer, hockey, karate, tae-kwon-do, handball, American football, rugby or tennis. The measured variable was the pressure required at the centre of the lesion to elicit the first pain reaction (tenderness reaction) at measuring time 0 (baseline) and then 1, 2, 3, 4, 6 and 24 h after the injury. The primary variable was the area under the curve (AUC) for tenderness over a six-hour period. The mean AUC differed significantly in the four groups (Kruskal-Wallis test p = 0.0001). Then six pairwise comparisons of two treatment groups each were carried out using the Mann-Whitney test. To control the multiple significance level of 5%, the adjusted p-values according to the Holm-Shaffer method were used in these tests. The three active gels were significantly superior to the placebo gel (Mann-Whitney test, p = 0.0004 in each case) in terms of the AUC. There were no significant differences between the active test substances in terms of the primary variable. The intensity of the pain was also measured on a visual analogue scale (VAS). The pain diminished more rapidly with the Reparil gels than with the placebo. The tolerability of all test substances was good. No adverse events were observed in any of the 126 patients. Escin combination gels are more effective than a placebo and are also well tolerated. Therefore, they can be recommended for the treatment of blunt injuries caused during sports and leisure activities.
Pabst
H
H
Hirtenweg 2a, Grünwald, Germany.
Segesser
B
B
Bulitta
M
M
Wetzel
D
D
Bertram
S
S
D000287:Administration, Topical; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D019540:Area Under Curve; D001134:Arm Injuries / Q000150:complications / Q000188:drug therapy*; D001265:Athletic Injuries / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004338:Drug Combinations; D004928:Escin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006801:Humans; D007869:Leg Injuries / Q000150:complications / Q000188:drug therapy*; D008297:Male; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010147:Pain Measurement; D017060:Patient Satisfaction; D012459:Salicylates / Q000008:administration & dosage*; D014949:Wounds, Nonpenetrating / Q000150:complications / Q000188:drug therapy*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D005782:Gels; D012459:Salicylates; C026191:diethylamine salicylate; D004928:Escin