Ginkgo-Spezialextrakt EGb 761® in der Behandlung der Demenz: Evidenz für Wirksamkeit und Verträglichkeit

Zusammenfassung

Der Ginkgo-Spezialextrakt EGb 761 greift in Pathomechanismen demenzieller Erkrankungen ein, wie Aβ-Aggregation, Störung der Mitochondrienfunktion, Insulinresistenz und Hypoperfusion. Die Wirksamkeit von EGb 761 bei demenziellen Erkrankungen (Alzheimer-Krankheit, vaskuläre Demenz) wurde in 10 randomisierten, kontrollierten Doppelblindstudien untersucht. In 3 der 4 großen, nach aktuellen Empfehlungen durchgeführten Studien, war EGb 761 dem Placebo hinsichtlich der kognitiven Leistung sowie einer oder mehrerer weiteren Messgrößen (global, funktionell oder psychopathologisch), die die klinische Relevanz der Effekte belegen, signifikant überlegen. Die Ergebnisse der 6 kleineren Studien stehen damit im Einklang. Eine Studie war inkonklusiv, wegen ungewöhnlich rigoroser Patientenselektion aber von fraglicher externer Validität. Subgruppenanalysen dieser Studie sowie die Ergebnisse der neuesten Studie legen nahe, dass Patienten mit neuropsychiatrischen Symptomen, die die Mehrheit der Demenzpatienten darstellen, am meisten von der Behandlung mit EGb 761 profitieren. Verzögerung der Symptomprogression, Responseraten und Numbers Needed to Treat (NNT) liegen für EGb 761 in derselben Größenordnung wie für Cholinesterasehemmer. Eine exploratorische Studie zum Vergleich von EGb 761 und Donepezil zeigte keine statistisch signifikanten oder klinisch relevanten Unterschiede. Damit hat EGb 761 zu Recht seinen Platz in der Behandlung von Patienten mit Demenz.

Abstract

The Ginkgo biloba extract EGb 761 interferes with pathomechanisms relevant to dementia, such as Aβ aggregation, mitochondrial dysfunction, insulin resistance, and hypoperfusion. The efficacy of EGb 761 in the treatment of dementia (Alzheimer’s disease and vascular dementia) has been studied in 10 randomised, controlled, double-blind clinical trials. In three of the four large trials conducted in accordance with recent recommendations EGb 761 was significantly superior to placebo with respect to cognitive performance and one or more further (global, functional or behavioural) outcomes demonstrating the clinical relevance of the findings. The findings from the six smaller trials are in line with those of the large trials. One trial was inconclusive, but of questionable external validity due to uncommonly rigorous patient selection. Subgroup analyses of this study together with the findings from the most recent clinical trial suggest that EGb 761 may be most beneficial to patients with neuropsychiatric symptoms, who actually constitute the majority of dementia patients. Delay in symptom progression, rates of clinically significant treatment response and numbers needed to treat (NNT) found for EGb 761 are in the same range as those reported for cholinesterase inhibitors. In an exploratory trial comparing EGb 761 and donepezil, no statistically significant or clinically relevant differences were seen. Hence, EGb 761 has its place in the treatment of dementia.

Schlüsselwörter

Demenz - Alzheimer - vaskuläre Demenz - Ginkgo biloba - EGb 761 - Review

Key words

dementia - Alzheimer’s disease - vascular dementia - Ginkgo biloba - EGb 761 - review

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