The study concludes that 3 months following a stroke caused by a clot, participants who received the celery seed drug, butylphthalide, in addition to prompt treatment for the clot, developed less severe neurological symptoms and resume satisfactory operation more quickly.
Derived from celery, butylphthalide protects brain tissue
Previous studies conducted in China have already documented the potential of butylphthalide to safely protect and preserve the brain from possible stroke-related damage, in the animal model of ischemic stroke. In China, butylphthalide is approved for use in the treatment of ischemic stroke, however it has yet to be approved in the rest of the world.
“This is the first trial to show the benefit of using a drug that protects the brain from damage caused by a lack of oxygen to brain tissue”says lead author Dr. Baixue Jia, an interventional neuroradiology clinician in the Department of Neurology at Beijing Tiantan Hospital (Beijing).
The clinical trial looked at 1,216 66-year-old participants with stroke initially treated with tPA or mechanical clot-busting therapy whether butylphthalide improved outcomes. Only participants, assessed 90 days following stroke who had minimal or moderate stroke symptoms were included in the study, excluding patients with severe symptoms (defined as >26 on the National Institutes Stroke Scale of Health, or NIHSS). The 607 participants in the intervention group therefore received butylphthalide, by daily intravenous injection for the first 14 days, followed by 76 days of oral capsules, the 609 controls receiving a placebo. Finally, the results were considered “favourable” in the event of:
- Initially mild to moderate stroke (4-7 on the NIHSS) with no symptoms following treatment;
- Stroke initially moderate to severe (8-14 on the NIHSS) and without residual symptoms or mild symptoms following treatment;
- Initially severe stroke (15-25 on the NIHSS) but with no residual symptoms or only mild disability.
The analysis reveals that:
- participants in the intervention group are 70% more likely to have a favorable outcome at 90 days vs controls;
- butylphthalide significantly improved function in patients who initially received tPA, those who received endovascular therapy, or those who received both tPA and endovascular therapy;
- there is no difference between the intervention group and the control group regarding secondary events, such as recurrent strokes and intracranial hemorrhage (cerebral hemorrhage).
- thus, patients who developed ischemic stroke treated with anti-clot medication and/or mechanical clot removal and who also received butylphthalide, developed milder neurological impairment, with fewer symptoms and better functioning at 3 months following the stroke.
What process? How butylphthalide works is unclear, and the team plans further research into the mechanisms of action of butylphthalide in humans.
Finally, while butylphthalide, originally made from celery seed extract, is not ready for use in standard stroke treatment, these very promising data call for larger clinical trials.
