(P-168) Systematic Review and Meta-analysis: Efficacy and Safety of Medical Cannabis in Children

Background: Despite the increased use of medical cannabis (MC), the efficacy and safety for indications such as epilepsy and chemotherapy-induced nausea and vomiting among children remain uncertain.

Objectives: To study the safety and efficacy of MC medical cannabis in children, using systematic review and meta-analysis.

Methods: The meta-analysis screening included published and unpublished studies through May-2020 in MEDLINE, EMBASE, and clinicaltrials.gov databases. Selection criteria included studies evaluating efficacy and safety outcomes of MC vs. control among children (18 years old). All potentially eligible studies were independently assessed by two reviewers and considered regardless of study design. Two investigators independently reviewed the data. The risk of bias was assessed by using the Revised Cochrane risk-of-bias tool for randomized controlled trials. I2 was calculated for heterogeneity, and meta-analyses, network meta-analysis, and trial sequential analysis were performed. We assessed the decrease in seizures in children with Dravet syndrome, serious adverse events, decreased appetite, and mental state changes. Relative Risk was calculated for dichotomous outcomes. When heterogeneity was observed, we performed subgroup analyses. We conducted a network meta-analysis (NMA) to estimate if a dose response is present.

Results: Out of 9,133 results, seven studies were included, all of which are RCTs with a total of 486 patients, three examined the indication of cannabidiol treatment in Dravet syndrome, two examined Nabilone as a preventive treatment for CINV; one study assessed Nabiximols spray’s efficacy for spasticity due to cerebral palsy or traumatic; and the remaining study assessed severe behavioral problems with intellectual disability. In Dravet syndrome analysis, cannabidiol was associated with a 50% reduction in seizures rate (RR=1.69, 95%CI[1.20 to 2.36]), and caregiver global impression of change (Median Estimated difference=(-1), 95%CI[-1.39 to -0.60]) in Dravet syndrome. A dose-response association between 10mg/kg/d and 20mg/kg/d cannabidiol and decreased appetite was found as well (RR=1.23, 95%CI[0.61 to 2.47], RR=2.40 95%CI[1.39 to 4.15], respectively). Cannabidiol and other MC substances were also associated with changes in mental state (RR=2.58, 95%CI[1.62 to 4.12]).

Conclusions: Cannabidiol was associated with clinical improvement in Dravet syndrome, although more evidence is warranted in other epilepsy syndromes and other indications. In addition, cannabidiol in high dosage was associated with a decreased appetite. Cannabidiol products and other MC products were associated with changes in mental state as well.