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cannabinoids in different diseases and case reports on the use of cannabis by
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|Title||Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis|
|Author(s)||Collin C, Davies P, Mutiboko IK, Ratcliffe S, for the Sativex Spasticity in MS Study Group|
|Journal, Volume, Issue||Eur J Neurology 2007;14(3):290–296.|
|Major outcome(s)||Significantly reduction in spasticity|
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 Ä-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.
|Dose(s)||25 mg (mean)|
|Participants||189 subjects with MS and spasticity|
|Type of publication||Medical journal|
|Address of author(s)||Christine Collin, Department of Neurorehabilitation, Royal Berkshire and Battle NHS Trust, London Road Reading, Berkshire RG1 5AN, UK (tel.: 0118 322 5367; fax: 0118 322 6751; e-mail: email@example.com).|