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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.

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