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.