47CLINICAL STUDIES NON-RANDOMIZED OBSERVATIONAL STUDIES

Conclusion Traumeel® was at least equivalent to NSAID therapy in reducing pain and improving mobility in the early treatment of epicondylitis.

Results Both treatments showed similar improvements in all five variables in the first

week with no significant differences in time to onset of action. Traumeel® showed markedly greater improvements in the variables pain at rest

(p<0.01), change in extensional joint mobility (p<0.05) and change in torsional joint mobility (p<0.01) compared with NSAIDs in the second week of treatment (p values from non-inferiority analysis at end of week 2).

Although the study was designed to assess non-inferiority, the analysis showed Traumeel® to be equivalent to NSAIDs on all variables and trended towards superiority on the variables pain at rest, extensional joint mobility and torsional joint mobility (Figure 19).

In global assessment, treatment was judged very good or good in 71% of Traumeel® patients compared with 44% of NSAID patients (p=0.013).

Compliance was reported as very high or high in 92% of Traumeel® patients compared with 81% of NSAID patients (p=0.11).

Figure 19 Mean difference with 97.5% confidence interval between symptom scores after two weeks for patients treated with NSAIDs (n=77) and Traumeel® (n=86).

Favors NSAIDs

-0.5 -0.4 -0.3 0.3 0.4-0.2 0.2-0.1 0.10.0

Favors Traumeel®

0.5 ∞-∞

* indicates statistically significant superiority of Traumeel® at p<0.05 ** indicates significant superiority of Traumeel® at p<0.01

Non-inferiority limit pain

Local pressure pain

Pain with movements

Pain at rest**

Extensional joint mobility*

Torsional joint mobility**Non-inferiority limit joint mobility