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May 2024

Behandlung von Sportverletzungen mit Traumeel-Salbe - Kontrollierte Doppelblindstudie

Author(s): Ambrus, P.

Journal/Book: Biologische Medizin. 1992; Heft 4: 260-268.

Abstract: A controlled double-blind study was conducted on outpatients with sports injuries, to compare with a placebo the effectiveness of Trau-meel Ointment in its normal com-mercially available form (Traumeel--S), and in a form of this preparation containing only six constituents (Traumeel-Sine). The primary crite-ria employed to assess medication effectiveness were regression of swelling and reduction in skin tem-perature. Secondary criteria for ef-fectiveness were the following: in-crease in maximum muscle force, reduction of pain intensity (pain index), time until resumption of effectiveness by patient and physi-cian.A total of 102 patients was inclu-ded in this study, with breakdown into groups of 34 patients Bach. It was possible to evaluate data for all patients except one (who was dis-qualified for not satisfying criteria for acceptance into the study). All other patients completed the study in compliance with the criteria for conduct of the study.With respect to the main criteria of skin temperature, no differences became apparent among the three treatment groups; variance was de-termined, however, for swelling. Convincing evidence has been ob-tained that there is no difference between the effectiveness of both differs from that of the placebo. Pu-rely formally, however, in the sense of control of multiple-Level alpha, only the difference between Traumeel-Sine and the placebo was able to be verified.All secondary criteria - such as maximum muscle force, pain index, resumption of training, and overall evaluation - confirm without exception, and with low P values, that there is no difference in effec-tiveness between the two Traumeel-preparations, but that a great diffe-rence does exist between these pre-parations and the placebo. The values of P on the 15th day were smaller than 0.001 for the pain index and the overall evulation. In addition, the Mann-Whitney cha-racteristic P(X<Y) reveals that these differences are of considerable clinical significance. At the end of the study, the patients and the physician evaluated the tolerance of the tested substances as good to very good. No undesired side effects were observed in any of the tree treatment groups. -

Keyword(s): Traumeel


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