33CLINICAL STUDIES RANDOMIZED CONTROLLED CLINICAL TRIALS

At 6 weeks, all patients reported total pain relief and normal functioning. Median time to return to normal activity was 19.09, 19.35 and 19.39 days for

Traumeel® ointment, Traumeel® gel and diclofenac groups, respectively. Adverse events (n=43) were reported by 31/447 patients (6.9%).

Events were mostly mild or moderate in severity, none was serious and all treatments were equally well tolerated.

Conclusions In this large-scale trial, Traumeel® ointment and gel decreased pain and improved

joint function to the same extent as diclofenac 1% gel in acute ankle sprain. All treatments demonstrated a good tolerability profile. Traumeel® can be considered an effective first-line local treatment option and an

alternative to topical diclofenac 1% gel for treating acute ankle sprain.

Table 3 Secondary efficacy variables

Traumeel® ointment N = 143

Traumeel® gel N = 140

Diclofenac gel N = 137

Ankle pain (VAS) score, median

Change from baseline (day 14), % -94.3 -93.4 -94.8

Baseline 52.6 53.1 55.7

Absolute score (day 14) 3.1 4.1 3.1

FAAM ADL subscale score, median points

Change from baseline (day 14) 41.7 40.5 41.7

Baseline 51.2 56.0 51.2

FAAM Sports subscale score, median points

Change from baseline (day 14) 50.0 50.0 50.0

Baseline 18.8 25.0 18.8

Ankle swelling, figure of eight , median, cm

Change from baseline (day 14) -0.67 -0.67 -0.57

Baseline 55.13 54.07 54.00

Normal function/activity, participants reporting scores of 0 or 1 n (%)

Day 14 128 (89.5%) 133 (95.0%) 131 (95.6%)

Baseline 29 (20.3%) 23 (16.4%) 27 (19.7%)

Global assessment of treatment efficacya

Day 14, mean 1.6 1.6 1.5

No. (%) participants reporting treatment as very good / good

131 (92.3%) 128 (92.1%) 127 (92.7%)

Rescue medication (paracetamol)

No. (%) participants (treatment/ follow up periods) 28 (19.7%) 29 (20.7%) 20 (14.6%)

Tablets per participant, mean 1.5 1.6 1.0

Negative figures indicate a reduction. a Participant assessed on a 5-point rating scale (1 = very good, 2 = good, 3 = satisfactory, 4 = no improvement, 5 = worsening of symptoms)