51CLINICAL STUDIES SURVEILLANCE STUDIES
Results The overall therapeutic results were graded as very good or good in 78.6%
of cases. Treatment was unsuccessful in only 3.5% of cases and only five cases (0.1%) were reported as worsening (Figure 21).
Results were rated as good or very good in 95.0% of patients with sprains, 86.9% tendovaginitis, 80.1% myogelosis, 78.6% epicondylitis, 74.8% periathropathia humeroscapularis and 59.5% degenerative joint disease.
Ratings appear higher when Traumeel® was administered without concomitant therapies: 85.2% good or very good for monotherapy, 79.6% additional non-medical therapy, 82.8% additional medical therapy, and 71.7% additional medical and non-medical therapies.
The fraction of good or very good results was greater with shorter administration intervals between injections than for applications with longer time periods between injections; e.g. daily application resulted as good and very good comments in 90.1%, weekly application only in 68.2%.
Traumeel® was well tolerated (see Clinical Safety section, page xx).
Figure 21 Results of therapy among patients treated with Traumeel® injection (n=3,421).
Pe rc
en ta
ge o
f p at
ie nt
s
Very good Good Satisfactory Unsuccessful Worsened
100
90
80
70
60
50
40
30
20
10
0 Satisfactory
17.8
Very good/good
76.8
0.1
WorsenedUnsuccessful
3.5
Conclusions Traumeel® injection solution is effective for therapy of post-traumatic conditions (sprains), as well as inflammatory and degenerative processes affecting the musculoskeletal system.