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

Abstract

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.

Cannabinoids and Epilepsy

“…Unlike Δ9-THC, CBD (or nabiximols, CBD/Δ9-THC in a 1:1 ratio) does not seem to produce significant intoxication [228], tolerance [229][230][231], or withdrawal effects [232]. CBD and/or nabiximols may counteract the Δ9-THC-dominant effects of cannabis withdrawal [233][234][235].…”

Divergent effects of cannabidiol on the discriminative stimulus and place conditioning effects of Δ9-tetrahydrocannabinol

“…The putative beneficial effects of combined THC and CBD also have been investigated recently in several clinical trials for multiple sclerosis, neuropathic pain, and varied neurogenic symptoms (Berman et al, 2004;Brady et al, 2004;Rog et al, 2005;Wade et al, 2004;Wade et al, 2003). In addition, Sativex®, a 1:1 THC: CBD ratio oromucosal spray formulation, is currently marketed in Canada for treatment of neuropathic pain associated with multiple sclerosis.…”

Cannabinoids and Tremor Induced by Motor-related Disorders: Friend or Foe?

“…The Bcannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis^(CAMS) study, where 611 of 630 patients were followed, reported 48 %, 40 %, and 33 % recuperation in tremor of patients consuming cannabis extract, Δ 9 -THC, and placebo, respectively; however, the difference in perception of tremor improvement was not statistically significant [96]. A double-blind randomized placebo controlled study failed to show any favorable effects of a cannabis-based medicinal extract on tremor in a subgroup of 13 patients [97,98]. In addition, although placebo recipients showed faster finger tapping than that of cannabis extract recipients in a randomized double-blind crossover trial amongst 14 tremulous patients, the study was unable to show any overall marked improvement on measures of objective tremor [99].…”