Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients.
The objective was to determine whether a cannabis-based medicinal extract (CBME) benefits a range of symptoms due to multiple sclerosis (MS). A parallel group, double-blind, randomized, placebo-controlled study was undertaken in three centres, recruiting 160 outpatients with MS experiencing significant problems from at least one of the following: spasticity, spasms, bladder problems, tremor or pain. The interventions were oromucosal sprays of matched placebo, or whole plant CBME containing equal amounts of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) at a dose of 2.5-120 mg of each daily, in divided doses. The primary outcome measure was a Visual Analogue Scale (VAS) score for each patient's most troublesome symptom. Additional measures included VAS scores of other symptoms, and measures of disability, cognition, mood, sleep and fatigue. Following CBME the primary symptom score reduced from mean (SE) 74.36 (11.1) to 48.89 (22.0) following CBME and from 74.31 (12.5) to 54.79 (26.3) following placebo [ns]. Spasticity VAS scores were significantly reduced by CBME (Sativex) in comparison with placebo (P =0.001). There were no significant adverse effects on cognition or mood and intoxication was generally mild.
Wade
Derick T
DT
Oxford Centre for Enablement, Windmill Road, Oxford OX3 7LD, UK. derick.wade@dsl.pipex.com
Makela
Petra
P
Robson
Philip
P
House
Heather
H
Bateman
Cynthia
C
D000336:Aerosols; D002185:Cannabidiol / Q000008:administration & dosage / Q000627:therapeutic use; D002188:Cannabis / Q000737:chemistry*; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D013759:Dronabinol / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D009061:Mouth Mucosa / Q000187:drug effects; D009103:Multiple Sclerosis / Q000150:complications*; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D010146:Pain / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D010147:Pain Measurement; D010936:Plant Extracts / Q000627:therapeutic use*; D014202:Tremor / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D001745:Urinary Bladder Diseases / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology
D000336:Aerosols; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol