Probleme des Wirksamkeitsnachweises bei immunstimulierenden Arzneimitteln, dargestellt am Beispiel eines pflanzlichen Immunmodulators

Abstract: The efficacy of drugs is demonstrated through clinical trials. Criteria for estimating the quality of clinical studies are named and discussed. Often it is impossible to determine whether these criteria have been observed or not without looking into the trial protocol and the original data.Basically, the principles of controlled clinical trials can be applied to phytotherapeutics as well. In detail there can be particularities.When evaluating clinical studies on immune modulators the particularity e.g. is that the effect of the preparation (immune Stimulation is not yet the therapeutical aim. The efficacy of immune modulators should rather be assessed through reduced infection rates or a more favourable course of infections. lt may be difficult to define a limited figure of effect parameters.Nevertheless an analysis of the duration of the disease (with or without immune modulation) represents a possible way to estimate the efficacy. Biometric methods can be applied similar to those of the survival time-analysis.Four clinical studies involving patients suffering from viral or bacterial respiratory infections are assessed by the example of a plant immune modulator. These trials are all controlled ones (verum versus placebo or antibiotical therapy plus immune modulation versus a sole antibiotic therapy).Through a summarizing assessment of studies by means of the Meta-analysis information on the efficacy can be improved and put on a broader inductive foundation. The studies are adequate for demonstrating the efficacy in accordance with the guidelines for the conduct of clinical trials.In this sense the efficacy of the testing drug for the treatment of viral and bacterial infections has been demonstrated.

Keyword(s): Klinische Prüfung

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