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Optimierung von Plazebos für klinische Doppelblindprüfungen

Erfahrungen mit einem Phytopharmakon

Paul G. Knipschild a , Robert Hörr b , Rainer Oschmann b , Erik van Rossum a und Martien C. J. M. van Dongen a

Abteilung Epidemiologie, Universität Maastricht a , Maastricht (Niederlande) (Leiter: Paul G. Knipschild), und Abteilung Klinische Forschung (R. H.) und Pharmazeutische Entwicklung (R. O.), Dr. Willmar Schwabe GmbH & Co.b , Karlsruhe

Optimization of Placebos for Double-Blind Clinical trials / Experience with a Phytopharmaceutical

The maintenance of double-blind conditions in placebo-controlled trials depends on the quality of the placebo preparation. The placebo should match the active substance-containing preparation as closely as possible, but it should not contain any substances that might themselves be pharmacologically active. Active substances characterized by a particular colour, taste, smell or other easily perceptible properties constitute a challenge to researchers. The way of developing a placebo that matches a phytopharmaceuti-cal to a satisfactory extent is described and discussed.

Key words Doppelblindmethode · Ginkgo-biloba-Extrakt · Kontrollierte klinische Studie · Plazebo