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37CLINICAL STUDIES RANDOMIZED CONTROLLED CLINICAL TRIALS

Conclusion Traumeel® is significantly more effective than placebo in the treatment of acute musculoskeletal injuries.

Figure 13 Changes in maximum muscle force and decrease in pain after 15 days of treatment in %.

Pe rc

en ta

ge c

ha ng

e

Traumeel® ointment N = 34

Placebo N = 34

100

90

80

70

60

50

40

30

20

10

0 Reduction in difference in maximum muscle force*

92

72

Decrease in pain intensity

79

63

* Between affected and healthy body part.

Results Swelling decreased more in the Traumeel® group than in the placebo group. By day 15, improvement in maximum muscle force was greater in the group

receiving Traumeel® versus placebo (92% improvement versus 72%, see Figure 13).

By day 15, pain was reduced by nearly 80% in the Traumeel® group and 63% in the placebo group (p<0.001) (Figure 13).

Normal activities were resumed earlier in patients receiving Traumeel® compared with placebo (mean 12.1 days versus 13.5 days, respectively).

Treatment with Traumeel® was assessed as very good or good by 85% of patients and 74% of physicians, compared with 50% and 35% for placebo treatment, respectively. In no case was treatment with Traumeel® assessed as poor compared with 35% of physician s assessments of placebo.

At the end of the study, all patients and physicians evaluated the tolerance of both Traumeel® and placebo either as good or very good .

No undesired side effects were observed during the course of the study.

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