Efficacy and safety of a once-daily formulation of Ginkgo biloba extract EGb 761 in dementia with neuropsychiatric features: a randomized controlled trial

• Published in: International journal of geriatric psychiatry 2011-11, Vol.26 (11), p.1186-1194
• Main Authors: Ihl, Ralf, Bachinskaya, Natalia, Korczyn, Amos D., Vakhapova, Veronika, Tribanek, Michael, Hoerr, Robert, Napryeyenko, Oleksandr
• Format: Article
• Language: English
• Subjects: Activities of Daily Living; Aged; Aged, 80 and over; Alzheimer's disease; Biological and medical sciences; Dementia; Dementia - drug therapy; Dementia - psychology; Double-Blind Method; EGb 761; Female; Free Radical Scavengers; Fundamental and applied biological sciences. Psychology; General aspects; Geriatric psychiatry; Geriatric psychology; Geriatrics; Ginkgo biloba; Herbal medicine; Humans; Male; Medical sciences; Mental health care; Middle Aged; Neuroprotective Agents - adverse effects; Neuroprotective Agents - therapeutic use; Neuropsychology; Phytotherapy; Plant Extracts - adverse effects; Plant Extracts - therapeutic use; Psychiatric Status Rating Scales; Psychoanalysis; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Quality of Life; randomized controlled trial; vascular dementia
• ISSN: 0885-6230; 1099-1166; 1099-1166
• DOI: 10.1002/gps.2662

Objective To test the efficacy and safety of a once‐daily formulation of EGb 761 in the treatment of patients with dementia with neuropsychiatric features. Methods Multi‐centre trial of 410 outpatients with mild to moderate dementia (Alzheimer's disease, vascular dementia or mixed form) scoring between 9 and 23 on the SKT cognitive test battery, at least five on the Neuropsychiatric Inventory (NPI) and three or higher in at least one item of the NPI. Patients were randomly allocated to double‐blind treatment with 240 mg of EGb 761 or placebo once daily for 24 weeks. Primary outcomes were the changes from baseline in the SKT total score and the NPI total score. The Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS‐CGIC), Activities of Daily Living International Scale (ADL‐IS), NPI distress score, DEMQOL‐Proxy quality‐of‐life scale and Verbal Fluency Test were secondary outcomes. Results At endpoint, patients treated with EGb 761 (n = 202) improved by −1.4 (95% confidence interval −1.8; −1.0) points on the SKT and by −3.2 (−4.0; −2.3) on the NPI total score, whereas those receiving placebo (n = 202) deteriorated by +0.3 (−0.1; 0.7) on the SKT and did not change on the NPI total score (−0.9; 0.9). Both drug‐placebo comparisons were significant at p