Wie werden Interaktionen in Studien zur konventionellen und komplementären Therapie bei menopausalen Beschwerden von Brustkrebspatientinnen berücksichtigt?

Zusammenfassung

Einleitung: Postmenopausale Symptome bei Mammakarzinompatientinnen unter antihormoneller Therapie führen zu einer hohen Abbrecherrate der Therapie. Therapeutisch kommen Methoden der konventionellen wie der komplementären Medizin infrage. Bei den natürlichen Substanzen werden Interaktionen diskutiert. Sie betreffen aber auch Substanzen der konventionellen Medizin. Ziel der Analyse ist die Frage, inwieweit in klinischen Studien und Reviews zur supportiven Therapie potenzielle Interaktionen berücksichtigt werden.

Material und Methodik: Mittels systematischer Recherche wurden klinische Studien und Reviews identifiziert und im Hinblick auf die Berücksichtigung möglicher Interaktionen analysiert.

Ergebnisse: Es wurden 46 klinische Studien und ein Cochrane-Review erfasst. Von den 35 Studien zur konventionellen medikamentösen Therapie berücksichtigten 5 (14 %) evtl. Interaktionen. Von 17 Studien zur Komplementärmedizin waren es 2 Arbeiten (11,7 %). Das Cochrane-Review geht nicht auf Interaktionen ein.

Diskussion: Für zukünftige Studien sollte bei nicht auszuschließender Interaktion eine Strategie zur Kontrolle der klinisch relevanten Folgen erarbeitet werden. Die Autoren schlagen hierfür Überlebens- und Rezidivdaten als sekundäre Endpunkte auch bei rein supportiven Therapiestudien als sinnvollen Ansatz vor. Die sich hieraus ergebenden Überlegungen für den Studienalltag werden im Artikel thematisiert.

Abstract

Introduction: Postmenopausal symptoms in breast cancer patients undergoing antihormone treatment lead to high drop-out rates from the therapy. From the therapeutic point of view, methods of both conventional and complementary medicine are concerned. Interactions are being discussed in cases of natural substances. However, they are also relevant for conventional medical substances. The aim of this analysis is to answer the question as to what extent potential interactions are taken into account in clinical studies and reviews on supportive therapies.

Materials and Methods: Clinical studies and reviews were identified by means of a systematic search and analysed with regard to the consideration of potential interactions.

Results: Altogether 46 clinical studies and one Cochrane review were found. Among the 35 studies on conventional drug therapies, 5 (14 %) took possible interactions into account. Among the 17 studies on complementary medicine, there were 2 (11.7 %) such publications. The Cochrane review did not mention interactions.

Discussion: For future studies in which interactions cannot be excluded, a strategy to control for their clinically relevant consequences should be developed. The present authors suggest that the use of survival and recurrence data as secondary endpoints, also for studies on purely supportive therapies, is a reasonable approach. The resulting considerations for study routines are listed thematically.

Schlüsselwörter

Mammakarzinom - antihormonelle Therapie - Hormonentzugserscheinungen - Komplementärmedizin - Interaktionen

Key words

breast cancer - antihormone therapy - hormone withdrawal signs - complementary medicine - interactions

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