Understanding Treatment-Resistant Epilepsy
Epilepsy is a chronic neurological condition affecting an estimated 50–70 million people globally. While many patients respond well to antiepileptic medications, approximately 30% develop treatment-resistant epilepsy (TRE), meaning seizures continue despite trials of at least two appropriate anti-seizure drugs.
This has led researchers to investigate alternative and adjunctive therapies, including pharmaceutical-grade cannabidiol (CBD).
In Malta and across the EU, interest in CBD has grown significantly, but scientific evidence must be clearly separated from consumer wellness marketing.
What Is Cannabidiol (CBD)?
Cannabidiol (CBD) is a non-intoxicating compound found in the Cannabis sativa plant.
Unlike tetrahydrocannabinol (THC), CBD does not produce psychoactive effects. In regulated medical contexts, purified CBD formulations have been studied for seizure reduction in specific severe epilepsy syndromes.
Important distinction:
• Pharmaceutical CBD (regulated, prescription-based)
• Retail CBD wellness products (food supplement framework in EU)
These are not equivalent.
What the Research Investigated
A retrospective observational study evaluated a standardized 24% CBD oil as add-on therapy in patients with refractory epilepsy of different causes.
Study Design
Participants:
• 37 patients
• Median age: 16.1 years
• Median follow-up: 68 weeks
Epilepsy types included:
• Epileptic encephalopathy (60%)
• Focal epilepsy (24%)
• Generalized epilepsy (16%)
CBD dosing:
• Started at 5–10 mg/kg/day
• Titrated up to 50 mg/kg/day
• Administered sublingually
• Adjusted according to clinical response
Seizure Reduction Outcomes
The study reported:
• 19% of patients became seizure-free
• 73% experienced more than 50% seizure reduction
• 5% had less than 50% improvement
• 1 patient discontinued due to lack of efficacy
These findings suggest meaningful seizure reduction in a majority of participants within this specific clinical setting.
Safety and Tolerability
Reported side effects were generally mild and temporary:
• Somnolence
• Reduced appetite
Observed in approximately 25% of patients.
No significant abnormalities in blood parameters or liver enzymes were identified in this cohort.
How This Fits Into Broader EU Research
CBD has been studied extensively in randomized controlled trials, particularly for:
• Dravet syndrome
• Lennox-Gastaut syndrome
• Tuberous sclerosis complex
In the European Union, specific purified CBD formulations have received regulatory approval under prescription-only frameworks.
However:
• Not all epilepsy types respond equally
• Dosing requires medical supervision
• Drug interactions must be monitored
• Liver enzyme testing may be required in some cases
CBD Regulation in Malta
In Malta:
• Prescription cannabinoid medicines fall under strict medical regulation
• Retail CBD products are regulated under EU food supplement rules
• Retail CBD is not licensed as an epilepsy treatment
Patients should never discontinue prescribed antiepileptic medication without medical supervision.
What This Means for Patients in Malta
Research suggests that standardized, medically supervised CBD formulations may reduce seizures in certain individuals with treatment-resistant epilepsy.
However:
• Evidence applies to regulated medical products
• Results vary between individuals
• Consumer CBD oils are not substitutes for prescription therapies
Anyone considering CBD in the context of epilepsy should consult a neurologist familiar with EU cannabinoid regulations.
Key Takeaways
• Treatment-resistant epilepsy affects roughly one-third of patients
• Clinical studies show promising results for regulated CBD formulations
• Most participants in this retrospective study experienced significant seizure reduction
• Side effects were generally mild
• Regulation and medical supervision are essential
CBD remains an active area of neurological research across Europe.
Educational Disclaimer
This content is for informational purposes only and does not constitute medical advice. Cannabis Clinics Malta does not promote illegal substances or make therapeutic claims. Always consult a licensed healthcare professional before making medical decisions.
