Zur Problematik klinischer Prüfungen mit Phytopharmaka

Journal/Book: Ärztezeitschrift für Naturheilverfahren. 1993; 34/10: 848-855.

Abstract: Clinical tests with phytopreparations are an principle subject to the requirements with respect to studies of the efficacy according to § 41 of the Act an Drugs. Specific problems render the practical performance difficult. The agents that determine the efficacy are often unknown and, thus, such constituents render any comparison with similar phytopreparations difficult (problem of the standard preparation). There are often no suitable pharmacological models for a clear statement as to pharmacodynamics, thus, rendering it difficult to assess the number of cases. Controlled tests against placebo are often not possible (especially in case of liquids). Criteria for inclusion and exclusion, selection of suitable parameters for the test and sufficient dosage have to be considered especially carefully.

Keyword(s): Phytopharmaka

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