Zusammenfassung
Placebokontrollierte Studien sind heutzutage der „Goldstandard“ für die „evidenzbasierte Medizin“ in der Untersuchung klinischer Fragestellungen wie der Schmerztherapie. Dabei steht der Placeboeffekt nicht im eigentlichen Fokus des Interesses, sondern dient lediglich als Kontrolle für die Spezifität des Effektes einer bestimmten Behandlung. Was Mediziner häufig nicht erkennen, ist, dass der Placeboeffekt ein echtes, messbares Korrelat einer psychoneurobiologischen Reaktion des Organismus darstellt und damit selbst Einfluss auf den Heilungsprozess, wie z. B. die Schmerzlinderung, nehmen kann. Placebo ist also nicht gleichbedeutend mit „keine Therapie“. Placeboresponder, Ausmaß und Dauer des Placeboeffektes stellen keinen fixen Anteil dar, sondern unterliegen deutlich größerer Variabilität als bisher angenommen. Der Mythos, dass Placeboresponder eine bestimmte Persönlichkeit haben, hat sich nicht bestätigt, jedoch können das Arzt-Patient-Verhältnis und soziokulturelle Faktoren einen entscheidenden Einfluss auf den Placeboeffekt nehmen. Psychologische Erklärungsansätze zeigen, dass die klassische Konditionierung, die gesteigerte Erwartungshaltung und die Motivation des Patienten das Ausmaß des Placeboeffektes bestimmen. Diese wiederum können Einfluss auf neurobiologische Systeme nehmen, wie z. B. das endogene Opioidsystem, das entsprechend den modernen bildgebenden Verfahren v. a. in schmerzrelevanten Arealen aktiviert wird und zum Effekt der Placeboanalgesie beiträgt. Placeboeffekte, die in kontrollierten klinischen Studien bewusst vermieden werden sollen, können in der klinischen Praxis zur Optimierung des Gesamttherapieeffektes erwünscht sein. Dies sollte die Maximierung des situativen Kontexteffektes jeder therapeutischen Intervention zur Steigerung des Gesamttherapieeffektes – wie es in den neuesten Leitlinien der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) zur postoperativen Schmerztherapie empfohlen wird –, jedoch nicht die beabsichtigte isolierte Gabe einer inerten Substanz bedeuten. Letzteres ist rigorosen ethischen Richtlinien unterworfen und nur nach vorheriger Begutachtung durch die Ethikkommission im Rahmen von kontrollierten klinischen Studien möglich. Eine denkbare Alternative mag der von Benedetti vorgeschlagene Weg sein, bei dem die versteckte Gabe eines Verums den spezifischen Effekt identifiziert, im Gegensatz zur angekündigten Gabe desselben Verums, das den spezifischen und den Placeboeffekt charakterisiert, woraus man letztendlich das Ausmaß des Placeboeffektes bestimmen kann.
Abstract
Placebo controlled studies examining clinical problems, e.g. in pain therapy, are considered the „gold standard“ for evidence-based medicine. In these studies the placebo effect itself is not the main focus of interest, but serves more as a control for the specificity of the effect of a certain treatment. What physicans in this context often do not realize is that the placebo effect itself represents a true measurable correlate of an organism’s psycho-neurobiological response and, thereby, influences the healing process, e.g. the pain relief. Placebo is, therefore, not equivalent to „no treatment“. The number of placebo responders, the degree and the duration of the placebo effect is not fixed, but are subject to a much greater variability then hitherto believed. The myth that placebo responders have a certain personality has not been proven correct; instead, the relationships between physicians and patients as well as sociocultural factors have a considerable impact on the placebo effect. Psychological theories explain that classical conditioning, enhanced expectation and motivation of the patient determine the degree of the placebo effect. These directly influence neurobiological systems such as the endogenous opioids which according to modern brain imaging are predominantly activated in pain-relevant areas and contribute to the effect of placebo analgesia. Placebo effects that should be deliberately excluded in controlled clinical trials, can be desirable in clinical practice to optimize the total therapeutic effect. This should mean that the context effect of each therapeutic intervention is maximized towards an improved therapeutic effect, as outlined in the recent AWMF guidelines for postoperative pain therapy, but should not include the administration of an inert substance. The latter is controlled by rigorous ethical guidelines and is only permitted in the context of ethically approved controlled clinical trials. A possible alternative is suggested by Benedetti et al. in which the hidden administration of an active substance identifies the specific response in contrast to the open application of the same substance characterizing the specific plus the placebo effect, after which the pure placebo effect can be determined.
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Oeltjenbruns, J., Schäfer, M. Klinische Bedeutung des Placeboeffektes. Anaesthesist 57, 447–463 (2008). https://doi.org/10.1007/s00101-008-1370-6
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DOI: https://doi.org/10.1007/s00101-008-1370-6