Evidence for the efficacy and effectiveness of THC-CBD oromucosal spray in symptom management of patients with spasticity due to multiple sclerosis

Zettl et al. ·Therapeutic Advances in Neurological Disorders Impact 3.7

Clear benefit 54 citations

SampleNarrative Review

Durationunclear

Endpointspasticity

Blindingunklar

DesignNarrative Review

Cannabinoidkombination

THC:CBD1:1

Routeoromukosal

Key finding

THC-CBD oromucosal spray shows efficacy in MS-induced spasticity with predominantly mild to moderate side effects (dizziness, fatigue).

Summary

Narrative review on THC-CBD oral spray in MS spasticity (affects >80% of MS patients); summarizes phase III RCTs (n≈1.600 patients or 1.500 patient-years) and real-world studies (>1.000 patients or >1.000 patient-years). Most common side effects: dizziness and fatigue, mostly mild to moderate.

PopulationMS patients with spasticity (moderate to severe, treatment-resistant spasticity); RCTs approx. 1600 patients, real-world studies >1000 patients

InterventionTHC-CBD oromucosal spray (nabiximols) as add-on therapy

OutcomeEvidence for efficacy and safety; most common adverse events: dizziness and fatigue (mostly mild to moderate)

Quality profile

Sample size ★★★★★

Blinding —

Effect size Clear benefit

Citations / year ★★★★★

Authors

Zettl UK, Rommer P, Hipp P, Patejdl R

DOI 10.1177/1756285615612659↗

Design: Narrative Review

Abstract

Spasticity, one of the main symptoms of multiple sclerosis (MS), can affect more than 80% of MS patients during the course of their disease and is often not treated adequately. delta-9-Tetrahydrocannabinol-cannabidiol (THC-CBD) oromucosal spray is a plant-derived, standardized cannabinoid-based oromucosal spray medicine for add-on treatment of moderate to severe, resistant multiple sclerosis-induced spasticity. This article reviews the current evidence for the efficacy and safety, with dizziness and fatigue as the most common treatment-related adverse events, being mostly mild to moderate in severity. Results from both randomized controlled phase III studies involving about,1600 MS patients or 1500 patient-years and recently published studies on everyday clinical practice involving more than 1000 patients or more than,1000 patient-years are presented.

The impediment to action advances action. — Marcus Aurelius