TRAUMEEL® PRODUCT MONOGRAPH32

Figure 10 Traumeel® (ointment and gel) is non-inferior to diclofenac gel 1% in reducing pain and improving function (day 7).

Traumeel® ointment (O) N = 143

Diclofenac gel 1% superiority

VAS pain (% change from baseline)

Traumeel® ointment + gel vs diclofenac

Traumeel® ointment + gel vs diclofenac

Traumeel® ointment vs diclofenac

Traumeel® ointment vs diclofenac

Traumeel® gel vs diclofenac

Traumeel® gel vs diclofenac

Mann-Whitney statistics

Intent-to-Treat population; MW, Mann-Whitney effect size; LBCI, Lower bound of the confidence interval 0.29/0.71= large difference; 0.36/0.64 = medium difference; 0.44/0.56 = small difference; 0.5 = equality

0.3 0.4 0.5 0.6 0.7

FAAM ADL subscale score: functional improvement (change from baseline)

MW=0.4910; LBCI=0.4321

MW=0.5260; LBCI=0.4656

MW=0.4682; LBCI=0.4004

MW=0.5169; LBCI=0.4485

MW=0.5142; LBCI=0.4464

MW=0.5352; LBCI=0.4666

Traumeel® ointment and gel superiority

Shaded area indicated inferiority

Traumeel® gel (G) N = 140 Diclofenac gel (D) N = 137

An overview of the primary endpoint results, day 7, is shown in Figure 10. Confidence intervals were above the predefined lower equivalence margin (0.40),

demonstrating that Traumeel® ointment and gel are non-inferior to diclofenac gel 1%.

Traumeel® ointment and gel were non-inferior to diclofenac for all secondary outcome variables (Table 3). Median reductions in ankle swelling were demonstrated by all groups on days

4, 7 and 14. On day 14, median reduction in ankle swelling was -0.67, -0.67 and -0.57 for

Traumeel® ointment, Traumeel® gel and diclofenac, respectively. Global assessment of treatment efficacy was similar between treatment

groups. On day 14, over 92% of participants rated their treatment as very good or

good in all treatment groups.