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Herbal Supplement May Protect Memory After Age 85 2-28-08
CORVALLIS, Ore., Feb. 27 -- The popular plant supplement ginkgo biloba may
help preserve memory in older octogenarians, but it may increase the risk of
stroke, researchers found.
Among 118 people 85 or older, those who took the supplement reliably had a 70%
lower risk of developing mild memory problems than those who took a placebo,
Hiroko Dodge, Ph.D., of Oregon State University here, and colleagues reported
online in Neurology.
However there were six strokes and one TIA among those taking ginko and none in
the placebo group.
The findings came from a randomized, placebo-controlled, double-blind, 42-month
pilot study with cognitively intact individuals (about 60% women) randomized to
standardized ginkgo extract or placebo. Sixty individuals took a ginkgo extract
three times a day and 58 took placebo.
Gingko biloba was chosen as a possible preventive agent because it is already
widely used even among the oldest old, is readily available, relatively
inexpensive, and it has been shown in preclinical studies to have a plausible
biologic efficacy as an antioxidant and on other brain aging mechanisms, the
researchers wrote.
Participants were recruited by mass mailings from August 2000 through September
2001 to age-eligible individuals in the greater Portland area.
All participants had annual in-person interviews with six-month follow-up to
assess changes in health status, including Mini-Mental State Examination (MMSE)
scores. These individuals had common stable medical conditions such as heart
disease and hypertension.
Kaplan-Meier estimation, Cox proportional hazard, and random-effects models were
used to compare the risk of progression
from Clinical Dementia Rating (CDR)=0 to CDR=0.5 and also the decline in
episodic memory function between the two groups.
Overall, 21 people developed mild memory problems or questionable dementia,
including 14 in the placebo group and seven who took the gingko extract, the
researchers found.
In the unadjusted intention-to-treat analysis, ginkgo showed no protective
effect on memory. The investigators found no reduced risk of progression to a
clinical dementia rating of 0.5 (log-rank test, P=0.06) in the ginkgo group.
There was also no decrease in the decline in memory function (P=0.05).
However, the researchers recognized that not all the people took the medications
reliably, so they did a secondary analysis accounting for compliance.
Controlling for medication adherence, the ginkgo group had a lower risk of
progression in the CDR=0 to CDR=0.5 (HR 0.33, 95% CI 0.12 to 0.89, P=0.02), and
a smaller decline in memory scores (P=0.04).
The almost 70% protective effect did not change after controlling for other
covariates at baseline, the researchers said. Only depressive symptoms predicted
progression.
There was no overall difference in adverse events in the two groups during the
study period (P=0.44 for difference in proportions).
However there were six ischemic strokes and one TIA (11.7%) in the ginkgo group
compared with none in the placebo group (P=0.01).
Gingko has been reported to cause bleeding-related complications, the
researchers said, but the strokes in this case were caused by blood clots, not
excessive bleeding. More studies are needed to confirm this finding, they said.
There were no deaths from stroke, and there was no difference in rates of other
events such as gastrointestinal ulcer, epitasis, or ecchymoses. Five individuals
in each group died.
Dr. Dodge noted that this is the first randomized, controlled trial of dementia
prevention in people 85 or older.
These data, he said, suggest that other larger studies should be able to
establish a brain protective effect for ginkgo, assuming that such variables as
dosing and the nature of the population samples enrolled (not a younger elderly
group) are not major determinants.
To control medication management, the researchers suggested that once-a-day
dosing might be preferable, although the optimum dosing regimen for ginkgo is
not known.
The suggestion of a protective effect in this study needs to be confirmed in
larger prevention trials taking into account medication compliance as well as
the stroke findings, the researchers said.
These results suggest that this oldest population should not be excluded because
of notions of frailty, poor adherence, or confounding medical problems. In fact,
the investigators said, the participants were pleased to contribute to science
and to "feel useful" at their advanced age.
The study was supported by grants from the National Institute on Aging and the
National Center for Complementary and Alternative Medicine. The ginkgo biloba
extract was provided by Thorne Research, Inc.