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Probleme der „evidence-based medicine“ in der Psychopharmakotherapie: Problematik der Evidenzgraduierung und der Evidenzbasierung komplexer klinischer Entscheidungsprozesse

Problems of evidence-based medicine in psychopharmacotherapy: problems of evidence grading and of the evidence basis for complex clinical decision making

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Zusammenfassung

Die Psychopharmakotherapie soll, analog zu anderen Bereichen der therapeutischen Medizin, im Sinne der Evidenzbasierung reglementiert werden. Das ist prinzipiell eine sinnvolle Entwicklung, die sich vorteilhaft auf die Routineversorgung auswirken wird. Allerdings dürfen die damit zusammenhängenden Probleme nicht übersehen werden. Ein wichtiges Problem ist die unterschiedliche Definition von Evidenzgraden. Werden placebokontrollierte Studien dabei zu einseitig priorisiert, so entfernt sich die Evidenz zu sehr von den Gegebenheiten des klinischen Alltags. Andererseits führt die Beschränkung auf Vergleichsuntersuchungen gegen Standardpräparate ohne Placebokontrolle möglicherweise zu Fehlschlüssen über die Wirksamkeit. Die Bevorzugung metaanalytischer Ergebnisse anstelle der Fokussierung auf relevante Einzelstudien führt zu einer dem Zulassungsverfahren entgegengesetzten Entscheidungslogik.

Wegen inhärenter methodischer Probleme des metaanalytischen Ansatzes, sollte im Sinne einer komplementären Sichtweise das narrative systematische Review seine traditionelle Bedeutung behalten. Ansätze zur Psychopharmakotherapie im Sinne der evidenzbasierten Medizin zu regeln, stoßen umso mehr an die Grenzen, je komplexer die klinische Situation und die diesbezügliche Entscheidungslogik ist. Auch in Zeiten der evidenzbasierten Medizin ist weiterhin ein Großteil komplexer klinischer Entscheidungen in der Psychopharmakotherapie mehr auf den Konsens über klinische Erfahrungen und Traditionen gestützt als auf eine entsprechende empirische Datenbasis.

Summary

Psychopharmacotherapy should now be regulated in the sense of evidence based medicine, as is the case in other areas of therapeutic medicine. In general, this is a meaningful development which will have a positive impact on routine health care. However, related problems should not be ignored. One important problem is the different definition of degrees of evidence. If placebo-controlled studies are prioritized, evidence deviates too much from the conditions of routine clinical care. However, the restriction to active comparative trials could lead to false conclusions about efficacy. In addition, if the focus is placed on the results of meta-analyses instead of considering relevant single studies, the result is a decision making logic contrary to that of the licensing process.

Due to inherent methodological problems of the meta-analytical approach, the narrative, systematic review should retain its traditional importance and be used to provide a complementary view. Attempts to regulate psychopharmacotherapy in the sense of evidence based medicine come closer to their limits the more complex the clinical situation and the respective decision making logic are. Even in times of evidence based medicine, a large part of complex clinical decision making in psychopharmacotherapy still relies more on a consensus about clinical experience and traditions than on relevant empirical databases.

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Der korrespondierende Autor weist auf folgende Beziehungen hin: Professor Möller hat von den folgenden Firmen Forschungsgelder erhalten bzw. er ist Mitglied des Advisory Boards oder erhält Honorare für Vorträge: AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Eisai, GlaxoSmithKline, Janssen Cilag, Lundbeck, Merck, Novartis, Organon, Pfizer, Sanofi Aventis, Sepracor, Servier, Wyeth. Professor Maier hat von den folgenden Firmen Forschungsgelder erhalten, bzw. er ist Mitglied des Advisory Boards oder erhält Honorare für Vorträge: AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen Cilag, Lundbeck, Merck, Pfizer, Sanofi Aventis, Schering, Böhringer. Die Präsentation des Themas ist unabhängig und die Darstellung der Inhalte produktneutral.

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Möller, HJ., Maier, W. Probleme der „evidence-based medicine“ in der Psychopharmakotherapie: Problematik der Evidenzgraduierung und der Evidenzbasierung komplexer klinischer Entscheidungsprozesse. Nervenarzt 78, 1014–1027 (2007). https://doi.org/10.1007/s00115-007-2291-3

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