49CLINICAL STUDIES SURVEILLANCE STUDIES
Results The overall therapeutic results were graded mostly as very good (48.3%) or
good (38.4%). Treatment was unsuccessful in only 2% of cases and only one case was reported as worsening (Figure 20).
Results were rated as good or very good in 98.9% of patients with hematoma, 97.0% contusion, 96.3% sprain, 93.2% edema, 92.1% bursitis, 88.1% tenosynovitis, 84.9% myogelosis, 80.4% epicondylitis, 71.6% periarthritis of the shoulder and 54.3% degenerative joint disease.
Ratings appear higher when Traumeel® was administered without concomitant therapies: 92.2% good or very good for monotherapy, 86.8% additional non-medical therapy, 86.6% additional medical therapy, and 76.9% additional medical and non-medical therapies.
Traumeel® was well tolerated (see Clinical Safety section, page xx).
Figure 20 Results of therapy for patients with the biological medication Traumeel® ointment (n=3,422).
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
11.3
Very good/good
86.7
0.03
WorsenedUnsuccessful
2.0
Conclusions Traumeel® satisfies all pre-requisites for low-risk therapy of trauma and its sequelae of soft tissue swelling, as well as inflammatory degenerative processes and processes associated with inflammation as manifested in the musculoskeletal system.
