TRAUMEEL® PRODUCT MONOGRAPH34

Topical Traumeel® vs. Placebo: Treatment of acute sprains of the ankle

Zell J, Connert WD, Mau J, Feuerstake G. Behandlung von akuten Sprunggelenksdistorsionen: Doppelblindstudie zum Wirksamkeitsnachweis eines homöopathischen Salbenpräparats. Fortschr Med. 1988;106(5):96 100. English translation available in Biol Ther.*

* Zell J, Connert WD, Mau J, Feuerstake G. Treatment of acute sprains of the ankle: a controlled doubleblind trial to test the effectiveness of a homeopathic ointment. Biol Ther. 1989;VII(1):1 6.

Study design Patients with distortion of the articular-capsule ligaments (sprain) and of the

tendons of the ankle were randomized to: Traumeel® n=33: 25 male, 8 female; mean age 23; mean time from injury

10.8 hours. placebo n=36: 25 male, 11 female; mean age 22; mean time from injury

10.5 hours. Treatment was administered on an out-patient basis for 2 weeks patients visited

clinic on days 1, 3, 5, 8, 10, 12 and 15. Both therapist and patients were blinded to medication. All patients received electrotherapy as basic treatment. Approximately 10 12 g of either Traumeel® or vehicle (placebo) was

administered by applying a compression ointment bandage.

End points Primary end point: a pilot study identified the difference in total angulation of

the joint measured in extension and flexion between affected and non-affected joints as a quantifiable objective measure for the degree of improvement in ankle mobility.

Secondary end points: the inversion angle (supination). the degree of pain suffered upon movement measured on a 3-point scale

with the score values of: 0=no pain; 1=mild pain; 2=severe pain.

Results In both groups, the basic treatment produced an improvement in joint mobility.

At day 10, the difference in total angulation of the joint between affected and non-affected joints was significantly less in Traumeel®-treated patients compared with placebo (p=0.015) (Figure 11).

Treatment was defined as successful if the difference in the angular sums between injured and non-injured ankles decreased to ≤10 by day 10. The probability of successful treatment was significantly greater with Traumeel® than placebo (p=0.03).

STUDY DESIGN FORMULATION INDICATION(S) Randomized, placebo-controlled double-blind study.

Traumeel® ointment. Activity-related ankle sprains.