Gingko Dipertene Lactone Meglumine Improves Functional Outcome in Stroke Patients

by | Sep 20, 2024 | 2023, Botanicals, Brain Health, Cardiovascular Health, Ginkgo Biloba, Stroke

Written by Chrystal Moulton, Science Writer. 50.8% of patients in the treatment group and 44.1% of patients in the placebo group achieved mRS score of 0 or 1 at 90 days (p<0.001).

elderly man gripping ballGingko biloba is composed of various active ingredients that has been shown to support neural activity by increasing blood flow to the brain, reducing edema of the brain, along with antioxidant, anti-inflammatory and anti-apoptosis properties1-4. Gingko diterpene lactone meglumine (GDLM) is a bioactive component created from gingko biloba extract, widely used in China for treatment of ischemic stroke1,5. Studies evaluating the efficacy of gingko diterpene lactone meglumine (GDLM) despite showing positive results2,6, lack in trial design and usually contain small sample size7. In the current trial, researchers investigated the effect of gingko diterpene lactone meglumine (GDLM) on patients with acute ischemic stroke7.

This study was designed as a double blind, placebo controlled, multicenter, parallel group trial. A total of 3452 eligible patients across 100 centers in China were included in this trial. Eligibility criteria for the study were:

  • Aged 18-80 years old
  • Clinically diagnosed with ischemic stroke within 48hrs of onset
    • National Institute of Health Stroke Scale [NIHSS] score 4-24
    • Modified Rankin Scale (mRS) score of 0 or 1 prior to onset
    • Upper or lower limb score of 2 on NIHSS
  • Signed informed consent

Eligible patients were assigned to either the treatment group receiving 5mL GDLM intravenous infusion daily for 14 days 48hrs after onset of stroke or placebo. Patients assigned to the placebo received saline. Both treatment and placebo were identical in appearance. The primary outcome was the proportion of patients with mRS score of 0 or 1 at 90 days. Secondary outcomes included any changes in NIHSS scores after 14 days and mRS score of 2 or less at 90 days. High scores on NIHSS and mRS indicate low physical functioning post ischemic stroke. Logistical regression was used to assess treatment affects.

Across both groups, median age of patients was 63 years old; median time for onset of stroke was 24hrs; and median baseline NIHSS score was 7. Following 14 days of GDLM treatment, 50.8% of patients in the treatment group [877 out of 1725] and 44.1% of patients in the placebo group [759 out of 1723] achieved mRS score of 0 or 1 at 90 days (p<0.001). Furthermore, the proportion of patients with improved function was 83.8% in the treatment group compared to placebo at 69.5% (p<0.001). The proportion of patients with a 1-point increase in NIHSS scores at day 7 was higher in the placebo versus the treatment group (4.6% versus 3.0%, p=0.01 respectively). Similar incidence of adverse events was reported in both treatment and placebo groups.

Overall, results from this multicenter placebo controlled trial demonstrated that GDLM treatment improved the proportion of patients with mRS scores of 0 or 1 indicating a favorable functional outcome at 90 days compared to placebo. Additional trials will be needed to verify these results.

Source: Zhang, Qian, Anxin Wang, Qin Xu, Xue Xia, Xue Tian, Yijun Zhang, Xiaolong Li et al. “Efficacy and safety of ginkgo diterpene lactone meglumine in acute ischemic stroke: a randomized clinical trial.” JAMA Network Open 6, no. 8 (2023): e2328828-e2328828.

Open Access. This is an open access article distributed under the terms of the CC-BY License.

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Posted September 20, 2024.

Chrystal Moulton BA, PMP, is a 2008 graduate of the University of Illinois at Chicago. She graduated with a bachelor’s in psychology with a focus on premedical studies and is a licensed project manager. She currently resides in Indianapolis, IN.

References:

  1. Wang TJ, Wu ZY, Yang CH, et al. Multiple Mechanistic Models Reveal the Neuroprotective Effects of Diterpene Ginkgolides against Astrocyte-Mediated Demyelination via the PAF-PAFR Pathway. Am J Chin Med. 2022;50(6):1565-1597. doi:10.1142/s0192415x22500665
  2. Zhao S, Zheng H, Du Y, et al. The Clinical Efficacy of Ginkgo biloba Leaf Preparation on Ischemic Stroke: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2021;2021:4265219. doi:10.1155/2021/4265219
  3. Zhu PC, Tong Q, Zhuang Z, et al. Ginkgolide B for Myocardial Ischemia/Reperfusion Injury: A Preclinical Systematic Review and Meta-Analysis. Frontiers in physiology. 2019;10:1292. doi:10.3389/fphys.2019.01292
  4. Han JY, Meininger G, Luo JC, Huang QB. Editorial: Traditional Chinese Medicine: Organ Vascular Injury – Volume II. Frontiers in physiology. 2021;12:677858. doi:10.3389/fphys.2021.677858
  5. Fan XX, Cao ZY, Liu MX, et al. Diterpene Ginkgolides Meglumine Injection inhibits apoptosis induced by optic nerve crush injury via modulating MAPKs signaling pathways in retinal ganglion cells. J Ethnopharmacol. Oct 28 2021;279:114371. doi:10.1016/j.jep.2021.114371
  6. Zhao H, Guo Q, Li B, Shi M. The Efficacy and Safety of Ginkgo Terpene Lactone Preparations in the Treatment of Ischemic Stroke: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Front Pharmacol. 2022;13:821937. doi:10.3389/fphar.2022.821937
  7. Zhang Q, Wang A, Xu Q, et al. Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Netw Open. Aug 1 2023;6(8):e2328828. doi:10.1001/jamanetworkopen.2023.28828

 

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