Zusammenfassung:
Einleitung: Die Aussagekraft offener Studien zur Wirksamkeit von Neuroleptika wird aus methodischen
Gründen oft bezweifelt. Bislang existieren jedoch kaum Studien, die Ergebnisse offener
mit denen doppelblinder, kontrollierter Studien vergleichen. Ziel der vorliegenden
Untersuchung war der Vergleich von Wirksamkeit und Verträglichkeit in Abhängigkeit
von der gewählten Methode, um einen Anhalt für die Wertigkeit der Ergebnisse offener
Studien zu gewinnen. Methodik: Nach einer Literaturrecherche wurden nach Anwendung der Einschlusskriterien fünf
Neuroleptika identifiziert, für die mindestens je drei offene und doppelblinde, kontrollierte
Studien mit ausreichender Fallzahl und Behandlungsdauer vorlagen, aus denen das Behandlungsresultat
methodisch ausreichend quantifizierbar und vergleichbar (BPRS-Score, Responserate)
zu entnehmen war. Ergebnisse: Es existieren keine Unterschiede hinsichtlich der Reduktion des BPRS-Scores oder
der Responserate zwischen offenen und kontrollierten Untersuchungen für alle fünf
Neuroleptika. Auch die Wirksamkeit der Präparate untereinander unterschied sich nicht.
Diskussion: Doppelblinde, kontrollierte Studien bleiben unverändert unverzichtbar in der Prüfung
neuer Substanzen. Die Ergebnisse zur Wirksamkeit von Neuroleptika aus methodisch gut
durchgeführten offenen Studien sind aber aussagekräftig und verdienen mehr Beachtung
als bisher. Sie können sinnvoll zur Vorbereitung und Durchführung doppelblinder, kontrollierter
Studien beitragen.
Objective: Due to methodological reservations, results concerning the efficacy of neuroleptics
in open trials are often regarded with doubt. Until now, there are nearly no studies
comparing findings of controlled double-blind with those of open trials. Aim of this
study was to investigate if results of an open or double-blind approach differ and
hereby to gain information about the validity of open trials. Methods: After a literature research, five neuroleptics were identified for which at least
3 open and 3 double-blind trials exist which met the inclusion criteria and from which
either the reduction of the BPRS (Brief Psychiatric Rating Scale)-score or the response
rate could be determined. Results: There were no differences in the reduction of the BPRS-score or response rate for
all 5 neuroleptics between open and double-blind trials. Furthermore, the efficacy
of all 5 neuroleptics was comparable. Conclusions: Double-blind controlled studies are essential in the investigation of new compounds.
But results of methodologically well performed open studies are valid and deserve
more attention. Preceding open trials may help in the design of double-blind studies.
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Dr. Frank-Gerald Pajonk
Klinik für Psychiatrie und Psychotherapie
Universitätskrankenhaus Hamburg-Eppendorf
Martinistr. 52
20246 Hamburg
Email: pajonk@uke.uni-hamburg.de
