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A combination of biologically active components of Ginkgo biloba given by intravenous (IV) injection for 14 days was associated with improved early cognitive recovery in patients with acute ischemic stroke, in a placebo-controlled trial.

These results will be presented at the International Stroke Conference 2024 being held this week in Phoenix, Arizona.

The study included 3452 patients from 100 Chinese centers with acute ischemic stroke enrolled within 48 hours of onset. They were randomly assigned to receive daily IV injections of ginkgo diterpene lactone meglumine (GDLM; a combination of the biologically active components of Ginkgo biloba) at a dose of 25 mg for 14 days or placebo injections.

Cognitive performance was assessed before treatment, at 14 days and at 90 days using the Montreal Cognitive Assessment score. At baseline, before beginning treatment, most patients' cognitive status was moderately impaired, with an average score of 17 out of 30.

By day 14, patients who received the Ginkgo biloba compound injections had improved cognitive scores compared with those who received the placebo, an average of 3.93 points vs 3.62 points higher.

The improvement continued to be seen at day 90, at which time the Ginkgo biloba group's score had increased by an average of 5.51 points vs 5.04 points in the placebo group. These differences were significantly significant.

Further analysis showed that the scores of visual space and execution and language in the GDLM group were significantly higher than those in the placebo control group at day 14, and the scores of visual space and execution, attention, language, and abstract in the GDLM group were significantly higher than those in the placebo control group at day 90.

"Since the follow-up time in this study was only 90 days, the longer-term effect of GDLM injections requires longer-term research," said study author, Anxin Wang, PhD, associate professor of clinical epidemiology at the Beijing Tiantan Hospital of the Capital Medical University in Beijing, China.

"GDLM has shown a neuroprotective effect through multiple mechanisms, such as improving brain cells' tolerance to hypoxia and increasing cerebral blood flow. GDLM also has neuroprotective antioxidation, anti-inflammation, and anti-apoptosis properties," Wang noted.

"Additionally, laboratory studies have previously indicated that GDLM may promote secretion of chemicals associated with avoiding neurodegenerative diseases, such as Parkinson's disease and Alzheimer's disease," she said. "If our positive results are confirmed in other trials, GDLM injections may someday be used to improve cognitive function for patients after ischemic stroke."

Ginkgo biloba is an herb extracted from the dried leaves and seeds of the ginkgo tree, one of the oldest living tree species and native to East Asia. It is widely used in traditional Chinese medicine. IV GDLM preparations are used in China as a complementary treatment for ischemic stroke. While oral Ginkgo biloba supplements are widely available in the United States, Ginkgo biloba is not approved for medicinal use by the US Food and Drug Administration (FDA).

In early 2023, researchers reported the main results from this study showing the GDLM injections to be associated with better overall recovery in patients with acute stroke.

Neuroprotective Benefits

Commenting on these latest findings, Sheryl L. Chow, PharmD, chair of the scientific statement writing committee for the 2022 American Heart Association Scientific Statement: Complementary and Alternative Medicines in the Management of Heart Failure, said she did not find the results surprising.

She pointed out that previous studies have reported some modest benefits of Ginkgo biloba in patients with dementia, and there have other studies in patients with ischemic stroke that have shown improvement in outcomes.

"Mechanistically, there are some neuroprotective benefits associated with some of the properties with ginkgo, anti-inflammatory properties, and also antioxidant. But most notably, which I think is very relevant to this particular patient population, is the antiplatelet effects," Chow, who is an associate professor of pharmacy practice and administration at Western University of Health Sciences in Pomona, California, and an associate clinical professor of medicine at the University of California, Irvine, noted.

But she cautioned that patients with stroke should not take Ginkgo biloba or other herbs or supplements without discussing it with their doctor and pharmacist.

"If this new research proves to be effective in future clinical trials, it may be a valuable tool for after-stroke care; however, efficacy and safety would need to be demonstrated to meet the same standards as all prescription medications and secure FDA approval," she said.

The study was an exploratory analysis conducted within a larger trial, so the results need to be confirmed in an independent trial. These results of adults in China may not be generalizable to people in other countries, Chow added.

The study was funded by the Jiangsu Kangyuan Pharmaceutical Co., the manufacturer of the GDLM preparations tested in this trial.