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|Title||Multiple Sclerosis and Extract of Cannabis: results of the MUSEC trial.|
|Author(s)||Zajicek JP, Hobart JC, Slade A, Barnes D, Mattison PG; on behalf of the MUSEC Research Group.|
|Journal, Volume, Issue||J Neurol Neurosurg Psychiatry. 2012 Jul 12. [Epub ahead of print]|
|Major outcome(s)||Significant improvement by the cannabis extract Cannador of spasticity and pain.|
ObjectiveMultiple sclerosis (MS) is associated with chronic symptoms, including
muscle stiffness, spasms, pain and insomnia. Here we report the results of the
Multiple Sclerosis and Extract of Cannabis (MUSEC) study that aimed to
substantiate the patient based findings of previous studies.Patients and
methodsPatients with stable MS at 22 UK centres were randomised to oral cannabis
extract (CE) (N=144) or placebo (N=135), stratified by centre, walking ability
and use of antispastic medication. This double blind, placebo controlled, phase
III study had a screening period, a 2 week dose titration phase from 5 mg to a
maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase.
The primary outcome measure was a category rating scale (CRS) measuring patient
reported change in muscle stiffness from baseline. Further CRSs assessed body
pain, spasms and sleep quality. Three validated MS specific patient reported
outcome measures assessed aspects of spasticity, physical and psychological
impact, and walking ability.ResultsThe rate of relief from muscle stiffness after
12 weeks was almost twice as high with CE than with placebo (29.4% vs 15.7%; OR
2.26; 95% CI 1.24 to 4.13; p=0.004, one sided). Similar results were found after
4 weeks and 8 weeks, and also for all further CRSs. Results from the MS scales
supported these findings.ConclusionThe study met its primary objective to
demonstrate the superiority of CE over placebo in the treatment of muscle
stiffness in MS. This was supported by results for secondary efficacy variables.
Adverse events in participants treated with CE were consistent with the known
side effects of cannabinoids. No new safety concerns were observed.
|Participants||279 with multiple sclerosis|
|Type of publication||Medical journal|
|Address of author(s)||Clinical Neurology Research Group, Peninsula College of Medicine and Dentistry, University of Plymouth, Derriford, UK.|