title: Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.
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.
authors.affiliation: Department of Neurorehabilitation, Royal Berkshire and Battle NHS Trust, Reading, UK. christine.collin@rbbh-tr.nhs.uk
authors.forename: C
authors.initials: C
authors.lastname: Collin
authors.forename: P
authors.initials: P
authors.lastname: Davies
authors.forename: I K
authors.initials: IK
authors.lastname: Mutiboko
authors.forename: S
authors.initials: S
authors.lastname: Ratcliffe
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002185:Cannabidiol / Q000008:administration & dosage / Q000009:adverse effects; D002186:Cannabinoids / Q000008:administration & dosage* / Q000009:adverse effects; D002490:Central Nervous System / Q000187:drug effects / Q000503:physiopathology; D004311:Double-Blind Method; D013759:Dronabinol / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D010919:Placebos; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D002186:Cannabinoids; D010919:Placebos; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol