Efficacy of artisanal preparations of cannabidiol for the treatment of epilepsy: Practical experiences in a tertiary medical center

Abstract

Medically refractory epilepsy continues to be a challenge worldwide, and despite an increasing number of medical therapies, approximately 1 in 3 patients continues to have seizures. Cannabidiol (CBD), one of many constituents of the Cannabis sativa or marijuana plant, has received renewed interest in the treatment of epilepsy. While highly purified CBD awaits Food and Drug Administration (FDA) approval, artisanal formulations of CBD are readily available and are seeing increased use in our patient population. Although randomized controlled trials of CBD are ongoing and promising, data regarding artisanal formulations of CBD are minimal and largely anecdotal. Here, we report a retrospective study to define the efficacy of artisanal CBD preparations in children with epilepsy. Given the known interaction between CBD and clobazam, we also conducted a subgroup comparison to determine if clobazam use was related to any beneficial effects of CBD. Additionally, we compared response rates with CBD and with clobazam alone within an overlapping patient cohort. A pediatric cohort with epilepsy of 108 patients was identified through a medical record search for patients using CBD oil. The addition of CBD resulted in 39% of patients having a >50% reduction in seizures, with 10% becoming seizure-free. The responder rate for clobazam was similar. No patients achieved CBD monotherapy, although the weaning of other antiepileptic drugs (AEDs) became possible in 22% of patients. A comparable proportion had AED additions during CBD therapy. With concomitant use of clobazam, 44% of patients had a 50% reduction in seizures upon addition of CBD compared with 33% in the population not taking clobazam; this difference was not statistically significant. The most common reported side effect of CBD was sedation in less than 4% of patients, all of whom were also taking clobazam. Increased alertness and improved verbal interactions were reported in 14% of patients in the CBD group and 8% of patients in the CBD and clobazam group. Benefits were more marked in the CBD alone group, in contrast to the CBD and clobazam group, but this difference was not statistically significant. In summary, these findings support efficacy of artisanal CBD preparations in seizure reduction with few significant side effects. The response to CBD was independent of concurrent clobazam use, although clobazam may contribute to the sedation seen with concurrent CBD use.

Cannabis‐based products for pediatric epilepsy: A systematic review

“…Subsequently, 142 records were screened in full‐text format, with 92 records meeting the eligibility criteria (Appendix ). Of these, 25 records corresponded to 23 unique published studies (four RCTs, 19 NRSs). An additional 33 records corresponded to trial registration records in ClinicalTrial.gov without reported results, and 34 corresponded to conference abstracts.…”

“…Of the 19 NRSs, two were comparative cohort studies (one prospective, one retrospective), 12 were single‐arm cohort studies (eight prospective, four retrospective), four were cross‐sectional surveys, and one was a case series (Appendix ). In total, the NRSs involved 1,115 participants (range = 5‐214) with variable baseline seizure frequency, and variable treatment durations (10 days to 57 months).…”

“…In total, the NRSs involved 1,115 participants (range = 5‐214) with variable baseline seizure frequency, and variable treatment durations (10 days to 57 months). Fourteen NRSs included participants with multiple forms of DRE (Appendix ), whereas some studies focused on specific syndromes, including Dravet syndrome, tuberous sclerosis complex (TSC), Sturge‐Weber syndrome, and febrile infection‐related epilepsy . The range of mean ages of included participants, where available, was between 7 and 14 years (Appendix ).…”

“…In total, four RCTs and 17 NRSs reported at least one outcome of interest and form the evidence base for this review. The evidence summary, including GRADE assessment, is shown in Table and .…”

Cannabis - current trends and methods of bioavailability

“…(1,2) While the popularity of cannabis as a recreational drug is rooted in its ability to alter sensory perception, a growing body of research also points to several medical benefits, including the relief of chronic and neuropathic pain, and as a treatment for insomnia, anxiety, epileptic seizures and nausea. (3,4,5,6,7,8) The Growing Acceptance of Cannabis…”