TRAUMEEL® PRODUCT MONOGRAPH40

Figure 16 Mean (95% CI) change from baseline in 50 ft walk pain versus study day.

Ch an

ge fr

om b

as el

in e

(m m

)

1

Traumeel® / Zeel®T N = 117

Placebo N = 111

* p<0.05

8 15 29 43 57 71 85 99 0

-10

-20

-30

-40

-50

injections 2nd 3rd1st

Study day

*

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The statistically normalized (Hedges g*) efficacy effect sizes for Traumeel® and Zeel® T compared to saline for the WOMAC OA Pain Subscale indicated persistent efficacy over time. These values were comparable or superior to the statistically normalized effect

sizes of independently reported standard-of-care IA and oral treatments versus IA placebo treatments published in the meta-analysis by Bannuru et al.36

Secondary endpoints Stiffness and physical function WOMAC Scores showed greater mean (SD)

decreases from baseline to end-of-study visit in Traumeel® and Zeel® T compared with saline but statistical significance was reached at Day 43 only (p= 0.0276).

Mean (SD) change in pain (VAS) from baseline to end-of-study following an unassisted 50-foot walk test improved significantly for Traumeel® and Zeel® T compared to the saline control (p = 0.0466). Traumeel® and Zeel® T was significantly superior to saline (p<0.05) on all days post-Day 8 (time of 2nd of 3 weekly injections) except Day 29 (p=0.0501) (Figure 16).

Overall, 102 patients receiving Traumeel® and Zeel® T and 87 in the saline-control group reported taking rescue-medication, with a median number of 23.5 and 46.0 tablets, respectively. No rescue medication was needed by 20 (17.1%) patients receiving Traumeel® and Zeel® T and 13 (11.7%) in the saline-control group.

Both Patient (PGA) and Physician Global Assessments (PhGA) improved during the course of the study, with greater improvement in patients who received