TRAUMEEL® PRODUCT MONOGRAPH36

Topical Traumeel® vs. Placebo: Treatment of acute musculoskeletal injuries

Böhmer D, Ambrus P. Treatment of sports injuries with Traumeel® ointment: a controlled double-blind study. Biol Ther. 1992;X(4):290 300.

Study design Patients with visible or palpable alteration in tissue, with injury as a consequence

of sprain or contusion of a slight or moderate degree of severity, were randomized to receive: Traumeel® n=34: 21 male, 13 female; mean age 31; 20 contusions, 14 sprains. placebo n=34: 23 male, 11 female; mean age 30; 11 contusions, 23 sprains.

Patients received their first medication no later than on the fourth day after the injury (no other medication was given between injury and beginning of treatment).

Following initial treatment, the patients applied 6 10 g of either Traumeel® or placebo ointment twice daily themselves, until day 15. An occlusive bandage was applied over the ointment for 30 minutes and the dressing covered with a cold compress while the injured extremity was rested.

End points Primary end point: abatement of swelling assessed by measured circumference. Secondary end points:

maximum muscle force (difference between the injured body part and the contralateral uninjured side).

pain intensity measured on a 3-point scale (0=no pain, 1=slight pain, 2=severe pain) and summed for: at rest, in motion, and under pressure (range 0 6).

time until resumption of normal activity. overall evaluation of effectiveness by patient and physician (very good, good,

moderate, poor).

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

Traumeel® ointment. Acute musculoskeletal injuries.