45CLINICAL STUDIES NON-RANDOMIZED OBSERVATIONAL STUDIES

Conclusion Traumeel® ointment is an effective and well-tolerated alternative to diclofenac 1% gel for the acute symptomatic treatment of patients with tendinopathy of varying etiology.

Non-inferiority analysis showed that Traumeel® was non-inferior to diclofenac for all variables assessed. For most variables, differences trended toward favoring the Traumeel® group (Figure 18). In particular, Traumeel® showed greater benefits on mobility. However, as this study was designed to show non-inferiority and did not include a superiority hypothesis, the possibility of superiority of Traumeel® over diclofenac on mobility variables could not be confirmed using these data.

Treatments were well-tolerated ( very good was reported in 92.5% and 87.9% of Traumeel® and diclofenac patients, respectively), with no treatment-related adverse events. Compliance was high or very high n both treatment groups in >95% of cases.

Figure 18 Point estimate and one-sided 95% confidence interval for the difference between scores for Traumeel® and control for all variables.

Favors diclofenac

Non-inferiority margin

-0.5 0.0 Favors Traumeel®

0.5 ∞

(Positive values indicate a favorable effect of Traumeel®; negative values favor the diclofenac group. The border of non-inferiority is shown as a dotted line. The zero line indicates no differences between therapeutic effects.)

Pressure

Stretch

Rest

Load

Pronation

Supination

Overall pain

Extension

Flexion

Rotation

Adduction

Overall mobility

All clinical variables

Abduction