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Study register · detail Prospektive Pilotstudie (unkontrolliert) · Chronic Pain · 2018

Medical Cannabis for Pediatric Moderate to Severe Complex Motor Disorders

Libzon et al. ·Journal of Child Neurology

Clear benefit GRADE Moderate 79 citations

Samplen = 25 Pat.

Duration5 months

EndpointSpasticity and dystonia

Blindingoffen

DesignProspektive Pilotstudie (unkontrolliert)

Cannabinoidkombination

THC:CBD1:20

Routeoral

Key finding

CBD-rich cannabis oil significantly improved spasticity, dystonia, sleep, pain and quality of life in children with complex movement disorders.

Summary

n=25 children (1–17 y.) with complex movement disorder, CBD-rich cannabis oil over 5 months; significant improvement in pain intensity in the overall cohort regardless of formulation group; accompanying improvements in quality of life and sleep also reported.

PopulationChildren with moderate to severe complex movement disorders (spasticity, dystonia), n=25, age 1–17 years

InterventionCBD-enriched cannabis oil 5%: group 1 with 0,25% THC (CBD:THC 20:1) or group 2 with 0,83% THC (CBD:THC 6:1), oral, 5 months

OutcomeSignificant improvement in spasticity/dystonia, sleep disturbances, pain intensity and quality of life in the overall cohort (p not specified); adverse events in 5/25 patients

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 Open-label

Effect size Clear benefit

Citations / year ★★★★★

Authors

Libzon S, Schleider L B, Saban N et al.

DOI 10.1177/0883073818773028↗

Design: Prospektive Pilotstudie (unkontrolliert)

Abstract

A complex motor disorder is a combination of various types of abnormal movements that are associated with impaired quality of life (QOL). Current therapeutic options are limited. We studied the efficacy, safety, and tolerability of medical cannabis in children with complex motor disorder. This pilot study was approved by the institutional ethics committee. Two products of cannabidiol (CBD) enriched 5% oil formulation of cannabis were compared: one with 0.25% δ-9-tetrahydrocannabinol (THC) 20:1 group, the other with 0.83% THC 6:1 group. Patients aged 1 to 17 years (n = 25) with complex motor disorder were enrolled. The assigned medication was administered for 5 months. Significant improvement in spasticity and dystonia, sleep difficulties, pain severity, and QOL was observed in the total study cohort, regardless of treatment assignment. Adverse effects were rare and included worsening of seizures in 2 patients, behavioral changes in 2 and somnolence in 1.

The impediment to action advances action. — Marcus Aurelius