Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.

Full Abstract

Symptoms relating to spasticity are common in multiple sclerosis (MS) and can be difficult to treat. We have investigated the efficacy, safety and tolerability of a standardized oromucosal whole plant cannabis-based medicine (CBM) containing delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), upon spasticity in MS. A total of 189 subjects with definite MS and spasticity were randomized to receive daily doses of active preparation (n = 124) or placebo (n = 65) in a double blind study over 6 weeks. The primary endpoint was the change in a daily subject-recorded Numerical Rating Scale of spasticity. Secondary endpoints included a measure of spasticity (Ashworth Score) and a subjective measure of spasm. The primary efficacy analysis on the intention to treat (ITT) population (n = 184) showed the active preparation to be significantly superior (P = 0.048). Secondary efficacy measures were all in favour of active preparation but did not achieve statistical significance. The responder analysis favoured active preparation, 40% of subjects achieved >30% benefit (P = 0.014). Eight withdrawals were attributed to adverse events (AEs); six were on active preparation and two on placebo. We conclude that this CBM may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS.

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Author information

Author/s: Collin, C (C); Davies, P (P); Mutiboko, I K (IK); Ratcliffe, S (S); Sativex Spasticity in MS Study Group;

Affiliation: Department of Neurorehabilitation, Royal Berkshire and Battle NHS Trust, Reading, UK. christine.collin(-atsign-)rbbh-tr.nhs.uk

Journal and publication information

Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: European journal of neurology : the official journal of the European Federation of Neurological Societies (Eur J Neurol), published in England. (Language: eng)

Reference: 2007-Mar; vol 14 (issue 3) : pp 290-6

Dates: Created 2007/03/14; Completed 2007/05/10;

PMID: 17355549, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Administration, Oral
Adult
Cannabidiol - administration & dosage; adverse effects
Cannabinoids - administration & dosage; adverse effects
Central Nervous System - drug effects; physiopathology
Double-Blind Method
Female
Humans

Male
Middle Aged
Multiple Sclerosis - complications; drug therapy; physiopathology
Muscle Spasticity - drug therapy; etiology; physiopathology
Placebos
Plant Extracts - administration & dosage; adverse effects
Tetrahydrocannabinol - administration & dosage; adverse effects
Treatment Outcome

Associated Chemicals: Cannabinoids (0) ; Placebos (0) ; Plant Extracts (0) ; Cannabidiol (13956-29-1) ; Tetrahydrocannabinol (1972-08-3)

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