title: Efficacy and safety ofGinkgo bilobastandardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial.
abstract: OBJECTIVE
  The aim of this randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety ofGinkgo bilobaextract in patients diagnosed with vascular cognitive impairment (VCI).
  
  
  METHODS
  A total of 90 patients (aged 67.1±8.0 years; 59 women) were randomly allocated (1:1:1) to receiveG. biloba120 mg,G. biloba60 mg, or placebo during a 6-month period. Assessment was made for efficacy indicators, including neuropsychological tests scores (Sandoz Clinical Assessment Geriatric Scale, Folstein Mini-Mental State Examination, Mattis Dementia Rating Scale, and Clinical Global Impression) and transcranial Doppler ultrasound findings. Safety indicators included laboratory findings, reported adverse reactions, and clinical examination.
  
  
  RESULTS
  At the end of 6-month study period,G. biloba120 and 60 mg showed a statistically significant positive effect in comparison with placebo only on the Clinical Global Impression score (2.6±0.8 vs 3.1±0.7 vs 2.8±0.7, respectively;P=0.038). The Clinical Global Impression score showed a significant deterioration from the baseline values in the placebo group (-0.3±0.5;P=0.021) as opposed toG. bilobagroups. No significant differences were found in the transcranial Doppler ultrasound findings. Adverse reactions were significantly more common and serious in the placebo group (16 subjects) than in either of the twoG. bilobaextract groups (eight and nine subjects, respectively), whereas laboratory findings and clinical examinations revealed no differences between the groups receivingG. bilobaextract and placebo.
  
  
  CONCLUSIONS
  According to our results,G. bilobaseemed to slow down the cognitive deterioration in patients with VCI, but the effect was shown in only one of the four neuropsychological tests administered. However, because of this mild effect in combination with a few adverse reactions, we cannot say that it is ineffective or unsafe either. Further studies are still needed to provide unambiguous evidence on the efficacy and safety ofG. bilobaextract.
authors.affiliation: Department of Neurology, University Hospital Center "Sestre Milosrdnice"; International Institute for Brain Health.
authors.forename: Vida
authors.initials: V
authors.lastname: Demarin
authors.affiliation: Department of Neurology, University Hospital Center "Sestre Milosrdnice".
authors.forename: Vanja
authors.initials: V
authors.lastname: Bašić Kes
authors.affiliation: Department of Neurology, University Hospital Center "Sestre Milosrdnice".
authors.forename: Zlatko
authors.initials: Z
authors.lastname: Trkanjec
authors.affiliation: Department of Neurology, University Hospital Center "Sestre Milosrdnice".
authors.forename: Mislav
authors.initials: M
authors.lastname: Budišić
authors.affiliation: Department of Neurology, University Hospital Center Zagreb, Zagreb; Department of Neurology, School of Medicine, University Josip Juraj Strossmayer, Osijek.
authors.forename: Marija
authors.initials: M
authors.lastname: Bošnjak Pašić
authors.affiliation: Department of Neurology, Stroke and Intensive Care Unit, University Hospital "Sveti Duh", Zagreb, Croatia.
authors.forename: Petra
authors.initials: P
authors.lastname: Črnac
authors.affiliation: Department of Neurology, School of Medicine, University Josip Juraj Strossmayer, Osijek; Department of Neurology, Stroke and Intensive Care Unit, University Hospital "Sveti Duh", Zagreb, Croatia.
authors.forename: Hrvoje
authors.initials: H
authors.lastname: Budinčević
keywords: Ginkgo biloba; dementia; vascular cognitive impairment