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.
Key words:
Bruises, strains, sprains, escin, heparin, Reparil, tenderness reaction.
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1 sulphated escin with heparinoid properties
M. Bulitta
CRM Biometrics GmbH
Weiherstr. 19
53359 Rheinbach
Germany
Phone: +49 (2226) 90984-30
Fax: +49 (2226) 90984-99
Email: m.bulitta@crmb.de