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
