Epilepsy
Study register · detail Pilot-Studie (prospektiv, unkontrolliert) · Epilepsy · 2019

A preliminary study of the effects of cannabidiol (CBD) on brain structure in patients with epilepsy.

Mixed GRADE Moderate 13 citations
Samplen = 27 Pat.
Durationfrom baseline until reaching a…
EndpointGray matter / cortical…
Blindingn.a.
DesignPilot-Studie (prospektiv, unkontrolliert)
Cannabinoidcbd
Routeoral
Key finding

CBD showed no adverse effects on cortical macrostructure, but significantly reduced seizure frequency and severity.

Summary

Pilot study (n=27 recruited, n=18 MRI subgroup), highly purified CBD 15–25 mg/kg/day in treatment-resistant epilepsy: Significant reduction in seizure frequency [t(17)=3.08, p=0.0069] and clinical seizure severity (CSSS) [t(17)=5.77, p<0.001] as well as adverse event profile (AEP) [t(17)=3.04, p=0.0074]. No significant changes in cerebral macrostructure (GMV, cortical thickness) detected.

P
PopulationPatients with treatment-resistant epilepsy, n=27 (MRI analysis n=18)
I
InterventionHighly purified CBD (Epidiolex®), 15–25 mg/kg/day, oral, daily
O
OutcomeNo significant changes in gray matter volume or cortical thickness; seizure frequency significantly reduced [t(17)=3.08, p=0.0069]
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size
Blinding
Effect size Mixed
Citations / year
Authors
Sharma AA, Nenert R, Allendorfer JB, Gaston TE, Grayson LP, Hernando K, Szaflarski JP.
DOI 10.1016/j.ebr.2019.100341
Design: Pilot-Studie (prospektiv, unkontrolliert)
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Abstract
Cannabis use is associated with changes in brain structure and function; its neurotoxic effects are largely attributed to Δ<sup>9</sup>-tetrahydrocannabidiol. Whether such effects are present in patients with epilepsy exposed to a highly-purified cannabidiol isolate (CBD; Epidiolex®; Greenwich Biosciences, Inc.) has not been investigated to date. This preliminary study examines whether daily CBD dose of 15-25 mg/kg produces cerebral macrostructure changes and, if present, how they relate to changes in seizure frequency. Twenty-seven patients with treatment-resistant epilepsy were recruited from the University of Alabama at Birmingham CBD Program. Participants provided seizure frequency diaries (SF), completed the Chalfont Seizure Severity Scale (CSSS) and Adverse Events Profile (AEP), and underwent MRI before CBD (baseline) and after achieving a stable CBD dosage (on-CBD). We examined T1-weighted structural images for gray matter volume (GMV) and cortical thickness changes from baseline to on-CBD in 18 participants. Repeated measures t-tests confirmed decreases in SF [t(17) = 3.08, <i>p</i> = 0.0069], CSSS [t(17) = 5.77, <i>p</i> < 0.001], and AEP [t(17) = 3.04, <i>p</i> = 0.0074] between the two time-points. Voxel-level paired samples t-tests did not identify significant changes in GMV or cortical thickness between these two time-points. In conclusion, short-term exposure to highly purified CBD may not affect cortical macrostructure.

The impediment to action advances action. — Marcus Aurelius