OBJECTIVES: To evaluate the efficacy, the dose-dependence, and the durability of the effect of the ginkgo biloba special extract EGb 761 (ginkgo) in older people with dementia or age-associated memory impairment. DESIGN: A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. SETTING:Homes for the elderly in the southern part of the Netherlands. PARTICIPANTS: Older persons with dementia (either Alzheimer's dementia or vascular dementia; mild to moderate degree) or age-associated memory impairment (AAMI). 214 Participants were recruited from 39 homes for the elderly. INTERVENTION: The participants were allocated randomly to treatment with EGb 761 (2 tablets per day, total dosage either 240 (high dose) or 160 (usual dose) mg/day) or placebo (0 mg/d). The total intervention period was 24 weeks. After 12 weeks of treatment, the initial ginkgo users were randomized once again to either continued ginkgo treatment or placebo treatment. Initial placebo use was prolonged after 12 weeks. MEASUREMENTS: Outcomes were assessed after 12 and 24 weeks of intervention. Outcome measures included neuropsychological testing (trail-making speed (NAI-ZVT-G), digit memory span (NAI-ZN-G), and verbal learning (NAI-WL)), clinical assessment (presence and severity of geriatric symptoms (SCAG), depressive mood (GDS), self-perceived health and memory status (report marks)), and behavioral assessment (self-reported level of instrumental daily life activities). RESULTS: An intention-to-treat analysis showed no effect on each of the outcome measures for participants who were assigned to ginkgo (n = 79) compared with placebo (n = 44) for the entire 24-week period. After 12 weeks of treatment, the combined high dose and usual dose ginkgo groups (n = 166) performed slightly better with regard to self-reported activities of daily life but slightly worse with regard to self-perceived health status compared with the placebo group (n = 48). No beneficial effects of a higher dose or a prolonged duration of ginkgo treatment were found. We could not detect any subgroup that benefited from ginkgo. Ginkgo use was also not associated with the occurrence of (serious) adverse events. CONCLUSIONS: The results of our trial suggest that ginkgo is not effective as a treatment for older people with mild to moderate dementia or age-associated memory impairment. Our results contrast sharply with those of previous ginkgo trials.
RCT Entities:
OBJECTIVES: To evaluate the efficacy, the dose-dependence, and the durability of the effect of the ginkgo biloba special extract EGb 761 (ginkgo) in older people with dementia or age-associated memory impairment. DESIGN: A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. SETTING: Homes for the elderly in the southern part of the Netherlands. PARTICIPANTS: Older persons with dementia (either Alzheimer's dementia or vascular dementia; mild to moderate degree) or age-associated memory impairment (AAMI). 214 Participants were recruited from 39 homes for the elderly. INTERVENTION: The participants were allocated randomly to treatment with EGb 761 (2 tablets per day, total dosage either 240 (high dose) or 160 (usual dose) mg/day) or placebo (0 mg/d). The total intervention period was 24 weeks. After 12 weeks of treatment, the initial ginkgo users were randomized once again to either continued ginkgo treatment or placebo treatment. Initial placebo use was prolonged after 12 weeks. MEASUREMENTS: Outcomes were assessed after 12 and 24 weeks of intervention. Outcome measures included neuropsychological testing (trail-making speed (NAI-ZVT-G), digit memory span (NAI-ZN-G), and verbal learning (NAI-WL)), clinical assessment (presence and severity of geriatric symptoms (SCAG), depressive mood (GDS), self-perceived health and memory status (report marks)), and behavioral assessment (self-reported level of instrumental daily life activities). RESULTS: An intention-to-treat analysis showed no effect on each of the outcome measures for participants who were assigned to ginkgo (n = 79) compared with placebo (n = 44) for the entire 24-week period. After 12 weeks of treatment, the combined high dose and usual dose ginkgo groups (n = 166) performed slightly better with regard to self-reported activities of daily life but slightly worse with regard to self-perceived health status compared with the placebo group (n = 48). No beneficial effects of a higher dose or a prolonged duration of ginkgo treatment were found. We could not detect any subgroup that benefited from ginkgo. Ginkgo use was also not associated with the occurrence of (serious) adverse events. CONCLUSIONS: The results of our trial suggest that ginkgo is not effective as a treatment for older people with mild to moderate dementia or age-associated memory impairment. Our results contrast sharply with those of previous ginkgo trials.
Authors: Bruce Diamond; Susan Johnson; Kathleen Torsney; Jennifer Morodan; Brian Prokop; Dana Davidek; Patricia Kramer Journal: Drugs Aging Date: 2003 Impact factor: 3.923