FROM:
Arch Neurol 1998 (Nov); 55 (11): 1409–1415
Oken BS, Storzbach DM, Kaye JA
Department of Neurology,
Oregon Health Sciences University,
Portland 97201, USA.
oken@ohsu.edu
OBJECTIVE: To determine the effect of treatment
with Ginkgo biloba extract on objective measures of
cognitive function in patients with Alzheimer disease (AD)
based on formal review of the current literature.
METHODS: An attempt was made to identify all English and
non-English-language articles in which G. biloba extract was
given to subjects with dementia or cognitive impairment.
Inclusion criteria for the meta-analysis were:
(1)
sufficiently characterized patients such that it was clearly
stated there was a diagnosis of AD by either Diagnostic and
Statistical Manual of Mental Disorders, Revised Third
Edition, or National Institute of Neurological Disorders and
Stroke- Alzheimer's Disease and Related Disorders
Association criteria, or there was enough clinical detail to
determine this by our review;
(2) clearly stated study
exclusion criteria, ie, those studies that did not have
stated exclusions for depression, other neurologic disease,
and central nervous system-active medications were
excluded;
(3) use of standardized ginkgo extract in any stated
dose;
(4) randomized, placebo- controlled and double-blind study
design;
(5) at least 1 outcome measure was an objective
assessment of cognitive function; and
(6) sufficient
statistical information to allow for meta-analysis.
RESULTS: Of more than 50 articles identified, the
overwhelming majority did not meet inclusion criteria, primarily
because of lack of clear diagnoses of dementia and AD. Only 4
studies met all inclusion criteria. In total there were 212
subjects in each of the placebo and ginkgo treatment groups.
Overall there was a significant effect size of 0.40
(P<.0001). This modest effect size translated into a 3%
difference in the Alzheimer Disease Assessment
Scale-cognitive subtest.
CONCLUSIONS: Based on a quantitative analysis of the
literature there is a small but significant effect of 3- to
6-month treatment with 120 to 240 mg of G. biloba extract on
objective measures of cognitive function in AD. The drug has
not had significant adverse effects in formal clinical
trials but there are 2 case reports of bleeding
complications. In AD, there are limited and inconsistent
data that preclude determining if there are effects on
noncognitive behavioral and functional measures as well as
on clinician's global rating scales. Further research in the
area will need to determine if there are functional improvements
and to determine the best dosage. Additional research will be
needed to define which ingredients in the ginkgo extract are
producing its effect in individuals with AD.