AUTHOR=Ebadi Seyyed Reza , Saleki Kiarash , Adl Parvar Tanin , Rahimi Negin , Aghamollaii Vajiheh , Ranji Sara , Tafakhori Abbas 

TITLE=The effect of cannabidiol on seizure features and quality of life in drug-resistant frontal lobe epilepsy patients: a triple-blind controlled trial

JOURNAL=Frontiers in Neurology

VOLUME=14

YEAR=2023

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1143783

DOI=10.3389/fneur.2023.1143783

ISSN=1664-2295

ABSTRACT=<sec><title>Background</title><p>Treatment-resistant epileptic seizures are associated with reduced quality of life (QoL). As polypharmacy with routine antiseizure medications has many side effects, novel add-on treatments are necessary. Recent research showed the efficacy of add-on therapy by cannabidiol (CBD) on refractory epilepsy. We attempted to extend data on the efficacy and safety profile of CBD in patients with frontal lobe treatment-resistant epilepsy.</p></sec><sec><title>Methods</title><p>A total of 27 patients were recruited into two CBD (<italic>n</italic> = 12) and placebo (<italic>n</italic> = 15) groups. The CBD group received a highly purified liposomal preparation of the drug in addition to routine antiseizure medications. The placebo group only received antiseizure medications. This experiment followed a triple-blinding protocol. Outcome measures were seizure frequency, the Chalfont seizure severity scale (CSSS), and the quality of life questionnaire score (QOLIE-31) assessed at baseline, 4 weeks, and 8 weeks.</p></sec><sec><title>Results</title><p>At 4 weeks, results indicated that a higher fraction of patients in the CBD group (66.67%) showed improvement in seizure, compared to the placebo group (20.00%). Before–after comparison revealed that CBD, unlike routine ADEs, was effective in reducing the occurrence of seizures at the study's final timepoint [mean difference 45.58, 95% CI (8.987 to 82.18), <italic>p</italic> = 0.009]. Seizure severity was not affected by study groups or time intervals (repeated-measures ANOVA <italic>p</italic> &gt; 0.05). <italic>Post-hoc</italic> tests found that the QoLI-31 score was improved at 8 weeks compared to baseline [mean diff. −5.031, 95% CI (−9.729 to −0.3328), <italic>p</italic> = 0.032]. The difference in cases who experienced enhanced QoL was meaningful between the CBD and placebo groups at 8 weeks [RR: 2.160, 95% CI (1.148 to 4.741), <italic>p</italic> = 0.018] but not at 4 weeks (<italic>p</italic> = 0.653). A positive finding for QoL improvement was associated with a positive finding for seizure frequency reduction [<italic>r</italic> = 0.638, 95% CI (0.296 to 0.835), <italic>p</italic> = 0.001]. Interestingly, limiting the correlation analysis to cases receiving CBD indicated that QoL improvement was not linked with seizure parameters such as severity and frequency (<italic>p</italic> &gt; 0.05).</p></sec><sec><title>Conclusion</title><p>The present study suggests the benefit of a purified and highly efficient preparation of CBD for seizure frequency reduction and improvement of QoL in refractory frontal lobe epilepsy. Further study with longer follow-ups and larger sample size is advised.</p></sec><sec><title>Clinical trial registration</title><p><ext-link ext-link-type="uri" xlink:href="https://www.irct.ir/trial/56790" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.irct.ir/trial/56790</ext-link>, identifier: IRCT20210608051515N1.</p></sec>