Abstract
To assess the effects of EGb 761® on specific BPSD, we analyzed data from all randomized, placebo-controlled, at least 20-week, trials of EGb 761® enrolling patients with dementia (probable Alzheimer's disease (AD), probable vascular dementia or probable AD with cerebrovascular disease) who had clinically significant BPSD (Neuropsychiatric Inventory (NPI) total score at least 6). Data were pooled and joint analyses of NPI single item composite and caregiver distress scores were performed by meta-analysis with a fixed effects model. Four trials involving 1628 patients (EGb 761®, 814; placebo, 814) were identified; treatment duration was 22 or 24 weeks; the daily dose of EGb 761® was 240 mg in all trials. Pooled analyses including data from the full analysis sets of all trials (EGb 761®, 796 patients; placebo, 802 patients) revealed significant superiority of EGb 761® over placebo in total scores and 10 single symptom scores. Regarding caregiver distress scores, EGb 761®-treated patients improved significantly more than those receiving placebo in all symptoms except delusions, hallucinations, and elation/euphoria. The benefit of EGb 761® mainly consists of improvement in symptoms present at baseline, but the incidence of some symptoms was also decreased. Twenty two- to twenty four-week treatment with Ginkgo biloba extract EGb 761® improved BPSD (except psychotic-like features) and caregiver distress caused by such symptoms.
Highlights
Behavioral and psychological symptoms of dementia (BPSD; referred to as neuropsychiatric symptoms, NPS) are common manifestations of Alzheimer’s disease (AD) as well as vascular dementia (VaD; Lyketsos et al, 2000)
Regarding the single item composite scores, most pronounced net effects were found for apathy (LSMD −0.82; 95% CI −1.00 to −0.64), sleep/nighttime behavior (−0.64; −0.80 to −0.47), depression (−0.59; −0.72 to −0.46), anxiety (−0.58; −0.73 to −0.43), and irritability/lability (−0.48; −0.63 to −0.33), p < 0.001 for all in favor of EGb 761® compared to placebo (Figure 1)
Net effects on the caregiver distress scale were largest for depression (LSMD −0.40; 95% CI −0.48 to −0.31), sleep/nighttime behavior (−0.38; −0.46 to −0.29), apathy (−0.37; −0.46 to −0.28), anxiety (−0.36; −0.45 to −0.27), and irritability/lability (−0.28; −0.37 to −0.19), p < 0.001 for all in favor of EGb 761® compared to placebo (Figure 2)
Summary
Behavioral and psychological symptoms of dementia (BPSD; referred to as neuropsychiatric symptoms, NPS) are common manifestations of Alzheimer’s disease (AD) as well as vascular dementia (VaD; Lyketsos et al, 2000). They adversely affect the patients’ quality of life (Karttunen et al, 2011), cause distress to caregivers (Cummings and McPherson, 2001), increase the risk for nursing home placement (Tun et al, 2007), and increase the cost of care (Jönsson et al, 2006). Ginkgo biloba extract EGb 761® has been found to be effective in the treatment of behavioral and psychological symptoms of dementia (BPSD)
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