←Multiple Sclerosis

Study register · detail Prospektive Beobachtungsstudie (Dual-Task-Experiment) · Multiple Sclerosis · 2019

Balance worsening associated with nabiximols in multiple sclerosis.

Castelli et al. ·Multiple Sclerosis Journal

Harm GRADE Very low 16 citations

Samplen = 22 Pat.

Duration1, 3 and 12 months

EndpointStatic posturography

Blindingn.a.

DesignProspektive Beobachtungsstudie (Dual-Task-Experiment)

Cannabinoidkombination

THC:CBD1:1

Routeoromukosal

Key finding

Nabiximols worsened postural control in MS patients, especially under dual-task conditions.

Summary

n=22 MS patients under nabiximols; after 1–12 months worsened postural control in Continuers (n=11) vs. Quitters (n=11): single task F=3,07, p=0,044; dual task F=4,90, p=0,005. Nabiximols had a negative effect on balance under multi-tasking conditions — relevant negative finding for therapeutic use in MS.

PopulationAdults with multiple sclerosis, n=22 (Continuers n=11, Quitters n=11)

InterventionNabiximols (oromucosal cannabis spray), treatment duration up to 12 months

OutcomeSignificantly greater impairment of postural control in Continuers vs. Quitters in Single-Task (F=3.07, p=0.044) and Dual-Task (F=4.90, p=0.005); cognitive-motor interference (Stroop Dual-Task: F=3.17, p=0.038)

Confidence in the evidence

Very low

The lowest GRADE level, the effect estimate remains uncertain.

Downgraded for

Imprecision

Quality profile

Sample size ★★★★★

Blinding —

Effect size Harm

Citations / year ★★★★★

Authors

Castelli L, Prosperini L, Pozzilli C.

DOI 10.1177/1352458518765649↗

Design: Prospektive Beobachtungsstudie (Dual-Task-Experiment)

Abstract

We performed a dual-task experiment to explore the effect of nabiximols on postural control in 22 patients with multiple sclerosis. They were assessed with static posturography and Stroop test in single- and dual-task conditions at treatment start and after 1, 3 and 12 months. At follow-up, we found more impaired postural control in single-task ( F = 3.07, p = 0.044) and dual-task ( F = 4.90, p = 0.005) conditions in patients who continued treatment (continuers, n = 11) compared with those who discontinued (quitters, n = 11). Continuers were more impaired at Stroop test only in dual-task condition ( F = 3.17, p = 0.038). Our findings suggest that nabiximols had a detrimental effect on postural control, especially in multi-tasking conditions.

The impediment to action advances action. — Marcus Aurelius