Abstract

Summary Objective: Psychopharmacotherapy should now be regulated in the sense of evidence-based medicine (EBM), as is the case in other areas of clinical treatment in medicine. Methods: Descriptive overview of limitations and problems of EBM in pharmacopsychiatry. Results: In general this is a meaningful development, which principally will have a positive impact on routine health care in psychiatry. But several related problems should not be ignored. So far consensus on an internationally accepted evidence graduation could not be reached, due to several difficulties related to this. For example, to focus on the results of meta-analyses instead of considering relevant single studies results in a decision-making logic which is in conflict with the rationale applied by drug authorities in the licensing process. Attempts to regulate psychopharmacotherapy in the sense of EBM come closer to their limits the more complex the clinical situation and the respective decision-making logic are. Conclusion: EBM has severe problems and limitations. Even in times of EBM a large part of complex clinical decision-making in psychopharmacotherapy still relies more on clinical experience and a consensus about clinical experience, traditions and belief systems than on results of efficacy oriented phase-III and effectiveness-oriented phase-IV clinical studies.

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