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.