Study register · detailSystematic Review · Epilepsy · 2019
Cannabis-based products for pediatric epilepsy: A systematic review
Elliott et al.·EpilepsiaImpact 4.1
MixedGRADEHigh82 citations
Samplek = 23 Studien
Durationunclear
ControlPlacebo
EndpointSeizure freedom
Blindingdoppelblind
DesignSystematic Review
Cannabinoidcbd
”Key finding
Cannabidiol showed a statistically significant reduction in monthly seizure frequency of 19,8% in RCTs and increased 50% seizure reduction compared to placebo, but no significant difference in seizure freedom, quality of life or sleep disturbances; increased diarrhoea rate.
Summary
Living systematic review on cannabis-based products in paediatric epilepsy; k=23 (4 RCTs + 19 observational studies), primarily cannabidiol. RCT evidence (moderate certainty/GRADE): significant reduction in median monthly seizure frequency with CBD vs. placebo (-19,8%, 95% CI -27,0% to -12,6%; 3 RCTs), RR=1,76 (95% CI 1,07-2,88; 1 RCT) for ≥50% seizure reduction. Increased risk of diarrhoea (RR=2,25, 95% CI 1,38-3,68; 3 RCTs). No significant differences in seizure freedom, quality of life or sleep disturbances.
P
PopulationChildren with epilepsy (predominantly pharmacoresistant epilepsy), pooled from 4 RCTs and 19 non-randomised studies
OutcomeSignificant reduction in monthly seizure frequency under cannabidiol vs. placebo (−19,8%, 95%-CI −27,0% to −12,6%; 3 RCTs); ≥50% seizure reduction significant (RR=1,76, 95%-CI 1,07–2,88; 1 RCT); no significant difference in seizure freedom, quality of life, sleep disturbances or vomiting; significantly increased risk of diarrhoea (RR=2,25, 95%-CI 1,38–3,68)
Confidence in the evidence
Very lowLowModerateHigh
High
The highest of four GRADE levels, the effect estimate is very reliable.
Objective: To assess the benefits and harms of cannabis-based products for pediatric epilepsy.
Methods: We identified in this living systematic review randomized controlled trials (RCTs) and nonrandomized studies (NRSs) involving children with epilepsy treated with cannabis-based products. We searched MEDLINE, Embase, PsycINFO, Cochrane Library, and gray literature (April 25, 2018). The primary outcome was seizure freedom; secondary outcomes were seizure frequency (total, >/=50% reduction), quality of life, sleep, status epilepticus, death, gastrointestinal adverse events, and visits to the emergency room. Data were pooled by random-effects meta-analysis. Risk of bias was assessed for each study, and GRADE was used to assess the quality of evidence for each outcome.
Results: Four RCTs and 19 NRSs were included, primarily involving cannabidiol. All RCTs were at low risk of bias, whereas all NRSs were at high risk. Among RCTs, there was no statistically significant difference between cannabidiol and placebo in seizure freedom (relative risk [RR] = 6.77, 95% confidence interval [CI] = 0.36-128.38; 1 RCT), quality of life (mean difference = 0.6, 95% CI = -2.6 to 3.9; 3 RCTs), sleep disruption (mean difference = -0.3, 95% CI = -0.8 to 0.2; 3 RCTs), or vomiting (RR = 1.00, 95% CI = 0.51-1.96; 4 RCTs). There was a statistically significant reduction in the median frequency of monthly seizures with cannabidiol compared with placebo (-19.8%, 95% CI = -27.0% to -12.6%; 3 RCTs) and an increase in the number of participants with at least a 50% reduction in seizures (RR = 1.76, 95% CI = 1.07-2.88; 1 RCT) and diarrhea (RR = 2.25, 95% CI = 1.38-3.68; 3 RCTs). Death and status epilepticus were infrequently reported.
Significance: Evidence from high-quality RCTs suggests that cannabidiol probably reduces seizures among children with drug-resistant epilepsy (moderate certainty). At this time, the evidence base is primarily limited to cannabidiol, and these findings should not be extended to all cannabis-based products.