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Psychother Psychosom Med Psychol 2006; 56(5): 193-201
DOI: 10.1055/s-2005-915449
Originalarbeit
© Georg Thieme Verlag KG Stuttgart · New York

Evidence Based Medicine: Widersprüche zwischen Surrogatergebnissen und klinischen Endpunkten

Surrogate End Point Fallacies - The Urge for Randomized Trials with Clinical EndpointsIngrid  Mühlhauser1 , Gabriele  Meyer1
  • 1Universität Hamburg, MIN-Fakultät, Fachwissenschaft Gesundheit
Further Information

Publication History

Eingegangen: 10. Oktober 2005

Angenommen: 3. Januar 2006

Publication Date:
03 March 2006 (online)

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Zusammenfassung

Folgenschwere Trugschlüsse und Irrtümer in der Medizin sind durch falsche Auswahl von Parametern zur Bewertung von Wirksamkeit und Sicherheit von Behandlungsmaßnahmen entstanden. Man hat sich auf Surrogate verlassen und nicht die für den Patienten relevanten Endpunkte untersucht. In Laboruntersuchungen und klinischen Experimenten können erwünschte Wirkungen auf messbare patho-/physiologische Parameter nachweisbar sein. Trotzdem kann das für den Patienten relevante Ergebnis ausbleiben oder sogar schädlich sein. Es werden Beispiele aus der medizinischen Prävention (menopausale Hormontherapie, Vitamine, Behandlung kardiovaskulärer Risikofaktoren), der klinischen Medizin (Herzmedikamente, Osteoporose), der Psychiatrie und Psychologie (Depression, Debriefing), der Pflege, sowie pädagogischer und sozialer Interventionen vorgestellt. Die Beispiele unterstreichen die Forderungen der evidenzbasierten Medizin, Wirksamkeit und Sicherheit von Interventionen durch randomisiert-kontrollierte Studien mit relevanten Endpunkten anstatt von Surrogatparametern nachzuweisen.

Abstract

Evidence increases that reliance on surrogate endpoints may be detrimental. This is particularly relevant for preventive medicine. Most impressive examples are hormone replacement therapy, vitamin therapy, and drug treatment of cardiovascular risk factors. Only a few of the oral antidiabetic agents have been studied in randomised trials using clinically relevant outcome measures. Most of these drugs or drug combinations turned out to be more dangerous than beneficial. They increased morbidity and mortality despite their blood glucose lowering effects (surrogate endpoints). New compounds are used without evidence of clinical benefit in millions of people worldwide. There is also an increasing number of examples on surrogate end point fallacies related to non-drug interventions (psychological, nursing, educational, social policy).

Key words

Evidence-based medicine - biological markers - treatment outcome

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Univ.-Prof. Dr. med. Ingrid Mühlhauser

Universität Hamburg · MIN-Fakultät, Gesundheit

Martin-Luther-King-Platz 6

20146 Hamburg

Email: Ingrid_Muehlhauser@uni-hamburg.de

URL: http://www.chemie.uni-hamburg.de/igtw/Gesundheit/gesundheit.htm

URL: http://www.gesundheit.uni-hamburg.de/

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