A new study in America has shown that a medication derived from celery seed along with prompt treatment of stroke, helps patients to have better outcomes.
People who had an ischaemic stroke and were treated with either clot-busting medicine and/or mechanical clot removal and also received butlyphthalide, which is a medication initially compounded from celery seed, experienced milder neurological symptoms with better functioning at three months after the stroke, in comparison to stroke patients who had their clots treated, but received a placebo medicine.
Previous research in China showed that butylphthalide has the potential to safely protect and preserve the brain from possible damage related to stroke in animal models with a clot-caused stroke.
The current study evaluated whether treatment with butylphthalide may improve the outcomes of people who initially received the intravenous clot-busting medication tissue plasminogen activator (tPA) and/or a mechanical clot removal procedure to physically remove the clot plus butylphthalide.
In china, butylphthalide is already licensed for use in treating ischaemic stroke; however is not licensed in the US.
Baixue Jia, co-author of the study, says: “This is the first trial to show the benefit of using a medication that protects the brain from damage caused by a lack of oxygen to brain tissue. The medication was given to patients with acute ischemic stroke who were also receiving treatment to restore blood flow to the brain.”
For the study, the researchers examined 90-day outcomes in 1,216 adults (average of 66 years; 68 per cent men) after they suffered a stroke that was initially treated with tPA or mechanical clot removal therapy.
The participants were treated between 2018 and 2022 at one of 59 medical centres in China. Individuals who had minimal stroke symptoms on their initial exam (defined as 0-3 on the National Institutes of Health Stroke Scale, or NIHSS) or had severe stroke symptoms (defined as >26 on the NIHSS) were excluded from this study.
Along with their physician-chosen initial treatment, participants were randomly assigned to receive either butylphthalide or a look-alike placebo administered by daily intravenous injection for the first 14 days, followed by 76 days of oral capsules.
The patients were randomly assigned to the butylphthalide treatment group (607 adults) or the placebo group (609 adults).
Neither the patients nor the research team knew which patients were assigned to which treatment.
Favourable outcomes were deemed by the following markers at 90-days post-stroke:
- an initially mild to moderate stroke (4-7 on the NIHSS) and had no symptoms (0 on the modified Rankin Scale, a scale that measures disability and dependence) after treatment;
- an initially moderate to serious stroke (8-14 on the NIHSS) and had no residual symptoms or mild symptoms that did not impair their ability to perform routine activities of daily living without assistance (0-1 on the disability scale); or
- an initially serious to severe stroke (15-25 on the NIHSS) had no remaining symptoms or a slight disability that impaired some activities yet still allowed a person to conduct their own affairs without assistance (0-2 on the disability scale).
Study Findings
- Participants in the butylphthalide group were 70% more likely to have a favorable 90-day outcome compared to the placebo group.
- Butylphthalide improved function equally well in the subsets of patients who initially received tPA, those who received endovascular therapy or those who received both tPA and endovascular treatment.
- Secondary events, such as recurrent stroke and intracranial hemorrhage (brain bleeds), were not significantly different between the butylphthalide and placebo groups.
Jia says: “Patients who received butylphthalide had less severe neurological symptoms and a better living status at 90-days post-stroke compared to those who received the placebo. If the results are confirmed in other trials, this may lead to more options to treat strokes caused by clots.
“How butylphthalide works isn’t clear, with animal studies suggesting various possible mechanisms. The next step should be investigating the exact mechanisms of butylphthalide in humans”
This study was limited by being based on participants who all received initial treatment with clot-busting intravenous medication or a procedure to remove the blood clot or both, meaning results may not be generalisable to stroke patients who received other treatments.
Results from this trial conducted in China may not be generalisable to other populations.
