35CLINICAL STUDIES RANDOMIZED CONTROLLED CLINICAL TRIALS
A significantly greater proportion of Traumeel® patients had no pain upon movement on day 10 compared with placebo patients (p≤0.0003) (Figures 11 and 12).
While more patients receiving Traumeel® than placebo achieved a difference in supination angle between injured and non-injured ankles of ≤7 at day 10, this did not achieve significance (p=0.13) (Figure 12).
Conclusions Traumeel® is effective in the treatment of activity-related sprains of the ankle. Traumeel® improved ankle mobility and pain significantly.
Figure 11 Proportion of patients achieving success in the different end points.
Pr op
or ti
on o
f p at
ie nt
s (%
)
Traumeel® ointment N = 33
Placebo N = 36
100
90
80
70
60
50
40
30
20
10
0 Total angulation of the joint*
p=0.015 (Bonferroni) 52
25
No pain upon movement**
p≤0.0003 (Bonferroni) 85
36
Supination angle***
76
56
p=0.13 (Fischer)
* Difference of the angular sums of flexion + extension between injured and healthy ankles decreased to 10 or less after 10 days of treatment.
** No longer pain upon movement after 10 days of treatment. *** Difference of the supination angle between the injured and non-injured ankles decreased to 7 or less
after 10 days of treatment.
Figure 12 Patients with no pain upon movement within two weeks after beginning therapy with Traumeel® ointment.
N um
b er
o f p
at ie
nt s
pa in
-f re
e
Traumeel® N = 33
Placebo N = 36
40
30
20
10
0
*p<0.0001
Day 12Day 10Day 8Day 5Day 1 Day 15
