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Effects of Ginkgo biloba Extract EGb 761® on neuropsychiatric symptoms of dementia: findings from a randomised controlled trial

Effekte von Ginkgo-Spezialextract EGb 761® auf neuropsychiatrische Symptome der Demenz: Ergebnisse einer randomisierten kontrollierten Studie

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Zusammenfassung

In einer 22-wöchigen, randomisierten Doppelblindstudie wurden 400 Patienten, die an einer Demenz mit neuropsychiatrischen Symptomen litten, mit Ginkgo-biloba-Extrakt EGb 761® (240 mg/die) behandelt oder erhielten Placebo. Patienten mit wahrscheinlicher Alzheimer-Krankheit, möglicher Alzheimer-Krankheit mit cerebrovaskulärer Erkrankung oder wahrscheinlicher vaskulärer Demenz wurden eingeschlossen, wenn sie Werte zwischen 9 und 23 im Syndrom-Kurztest (SKT) und mindestens 5 Punkte im Neuropsychiatrischen Inventar (NPI) aufwiesen. EGb 761® zeigte signifikant bessere Ergebnisse als Placebo in der Zielgröße (SKT) und allen Begleitgrößen. Der mittlere zusammengesetzte Skalenwert (Häufigkeit × Schwere) des NPI und der mittlere Wert für die Belastung der Betreuungsperson fiel unter EGb 761® von 21,3 auf 14,7 bzw. von 13,5 auf 8,7. Hingegen nahmen die entsprechenden Werte unter Placebo von 21,6 auf 24,1 bzw. von 13,4 auf 13,9 zu (p < 0.001). Die größten Verum-Placebo-Differenzen zugunsten von EGb 761® fanden sich für Apathie/Gleichgültigkeit, Angst, Reizbarkeit/Labilität, Depression/Dysphorie und Schlafstörungen/nächtliches Verhalten.

Summary

In a randomised, double-blind, 22-week trial 400 patients with dementia associated with neuropsychiatric features were treated with Ginkgo biloba extract EGb 761® (240 mg/day) or placebo. Patients with probable Alzheimer's disease, possible Alzheimer's disease with cerebrovascular disease or vascular dementia were eligible if they scored 9 to 23 on the SKT cognitive test battery and at least 5 on the Neuropsychiatric Inventory (NPI). EGb 761® was significantly superior to placebo with respect to the primary (SKT test battery) and all secondary outcome variables. The mean composite score (frequency × severity) and the mean caregiver distress score of the NPI dropped from 21.3 to 14.7 and 13.5 to 8.7, respectively, in the EGb 761®-treated patients, but increased from 21.6 to 24.1 and 13.4 to 13.9, respectively, under placebo (p < 0.001). The largest drug-placebo differences in favour of EGb 761® were found for apathy/indifference, anxiety, irritability/lability, depression/dysphoria and sleep/nighttime behaviour.

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Authors and Affiliations

  1. Chair of Psychiatry, Poltava Regional Psychiatry Hospital, Poltava, Ukraine

    Andrey Scripnikov

  2. Clinical Research Center of the Schwabe Group, Kyiv, Ukraine

    Alexander Khomenko

  3. Psychiatry Department, National Medical University, Kyiv, Ukraine

    Oleksandr Napryeyenko

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  1. Andrey Scripnikov
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  2. Alexander Khomenko
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  3. Oleksandr Napryeyenko
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for the GINDEM-NP Study Group

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Correspondence to Alexander Khomenko.

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Scripnikov, A., Khomenko, A., Napryeyenko, O. et al. Effects of Ginkgo biloba Extract EGb 761® on neuropsychiatric symptoms of dementia: findings from a randomised controlled trial. Wien Med Wochenschr 157, 295–300 (2007). https://doi.org/10.1007/s10354-007-0427-5

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  • DOI: https://doi.org/10.1007/s10354-007-0427-5

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