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Probleme und Ansätze zur Anlage und Bewertung von Therapiestudien bei Kopfschmerzpatienten

Problems in and approaches to the design and evaluation of therapeutic studies in patients with headache

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Abstract

A review of studies on migraine therapy shows a large heterogeneity in the clinical evaluation of different drugs and behavioral approaches. The percentages of efficacy of beta-blockers or behavior therapy (relaxation, biofeedback) range from 30% to 80%. Methodological differences from one author to another in the design and conduct of the studies might be causes of this variation. For both clinical practice and empirical research (e.g. replication of treatment studies) an uniformity in the application of different methodological techniques should be sought. This paper discusses the influence of methodological aspects on the success rates of treatment for chronic headaches, especially migraine. We question the present practice of applying traditional group experiments in headache research. Double-blind and placebo-controlled studies are often required, but this demand often cannot be niet in empirical reality because of the individuality of the patient or the heterogeneity of the symptoms. We discuss some alternative approaches that could be used in empirical research on headache therapy. The application of single-case experiments as well as methods of time-series analysis are described as a more appropriate approach to the evaluation of studies on chronic headaches.

Zusammenfassung

Die Angaben zur Wirksamkeit verschiedener Migräneprophylaktika und nichtmedikamentöser Behandlungsverfahren schwanken in der Literatur erheblich. Ein wesentlicher Grund dafür liegt in der Uneinheitlichkeit der verwendeten Forschungsmethoden. Dieser Beitrag diskutiert die verschiedenen methodischen Ansätze bei der Planung und Durchführung von klinischen Therapiestudien bei chronischen Kopfschmerzen. Ausgehend von versuchsplanerischen Überlegungen werden traditionelle Gruppenexperimente und deren implizite Forderungen (Doppelblind-Experimente, Placebokontrolle, Randomisierung) in Frage gestellt. Einzelfallanalytische Verfahren werden als mögliche methodische Alternative vorgestellt. Dabei werden spezifische Effizienzkriterien operational definiert. Der Vorteil von zeitreihenanalytischen Auswertungsverfahren insbesonderen bei Verlaufsmessungen mittels Kopfschmerztagebücher wird aufgezeigt. Der Beitrag soll Möglichkeiten der Anlage von Kopfschmerzstudien aufzeigen und zugleich zur Vereinheitlichung und Transparenz in der Kopfschmerzforschung anregen.

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Authors and Affiliations

  1. Zentrum für Nervenheilkunde der Universität, Niemannsweg 147, D-2300, Kiel

    Wolf-Dieter Gerber, Dieter Soyka & Uwe Niederberger

  2. Psychologisches Institut der Universität Freiburg i. Br., Freiburgi. B, Deutschland

    Gunther Haag

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  1. Wolf-Dieter Gerber
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  2. Dieter Soyka
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  3. Uwe Niederberger
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  4. Gunther Haag
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Gerber, WD., Soyka, D., Niederberger, U. et al. Probleme und Ansätze zur Anlage und Bewertung von Therapiestudien bei Kopfschmerzpatienten. Schmerz 1, 81–91 (1987). https://doi.org/10.1007/BF02527734

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