Purpose To evaluate the efficacy and safety of Ginkgo biloba extract (GBE) in acute ischaemic stroke and its impact on the recurrence of vascular events.
Methods We conducted a multicentre, prospective, randomised, open label, blinded, controlled clinical trial enrollingpatients with an onset of acute stroke within 7 days from five hospitals in China Jiangsu Province. Participants were assigned to the GBE group (450 mg GBE with 100 mg aspirin daily) or the control group (100 mg aspirin daily) for 6 months. The primary outcome was the decline in the Montreal Cognitive Assessment score at 6 months. Secondary outcomes were other neuropsychological tests of cognitive and neurological function, the the incidence of adverse events and vascular events.
Results 348 patients were enrolled: 179 in the GBE group and 169 in the control group. With 18 patients lost to follow-up, the dropout rate was 5.17%. Admission data between two groups were similar, but in the GBE group there was a marked slow down in the decline in the Montreal Cognitive Assessment scores (−2.77±0.21 vs −1.99±0.23, P=0.0116 (30 days); −3.34±0.24 vs −2.48±0.26, P=0.0165 (90 days); −4.00±0.26 vs −2.71±0.26, P=0.0004 (180 days)) compared with controls. The National Institutes of Health Stroke Scale scores at 12 and 30 days, the modified Rankin Scale scores for independent rate at 30, 90 and 180 days, and the Barthel Index scores at 30, 90 and 180 days in the GBE group were significantly improved compared with controls. Improvements were also observedin GBE groups for Mini-Metal State Examination scores of 30, 90 and 180 days, Webster’s digit symbol test scores at 30 days and Executive Dysfunction Index scores at 30 and 180 days. No significant differences were seen in the incidence of adverse events or vascular events.
Conclusions We conclude that GBE in combination with aspirin treatment alleviated cognitive and neurological deficits after acute ischaemic stroke without increasing the incidence of vascular events.
Trial registration number ChiCTR-TRC-12002688.
- ginkgo biloba extract
- ischemic stroke
- neurological function
- cognitive function
- incidence of vascular events
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SL, XZ, QF, JZ and MZ contributed equally.
Contributors YX designed the study, interpreted the data and revised the paper. SL, XZ, QF, JZ, HW, YW and LQ took charge of implementing the clinical study, following-up of the patients and collecting the data. BX and YC were responsible for the statistical analysis. SL and MZ wrote the paper. The corresponding author has the right to grant on behalf of all authors and does grant on behalf of all authors, an exclusive licence (or non exclusive for government employees) on a worldwide basis to the BMJ Publishing Group Ltd and its Licensees to permit this article (if accepted) to be published in Stroke and Vascular Neurology editions and any other BMJPGL products to exploit all subsidiary rights, as set out in our licence.
Funding The work was supported by the National Natural Science Foundation of China (81230026, 81630028), the Science and Technology Department of Jiangsu Province (BE2016610) and Jiangsu Province Key Medical Discipline (ZDXKA2016020).
Competing interests None declared.
Patient consent Obtained.
Ethics approval The study was approved by the ethics committee of the Affiliated Drum Tower Hospital of Nanjing University Medical School.
Provenance and peer review Not commissioned; externally peer reviewed.
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