Evidence for the efficacy and effectiveness of THC-CBD oromucosal spray in symptom management of patients with spasticity due to multiple sclerosis

Abstract

Spasticity, one of the main symptoms of multiple sclerosis (MS), can affect more than 80% of MS patients during the course of their disease and is often not treated adequately. δ-9-Tetrahydrocannabinol-cannabidiol (THC-CBD) oromucosal spray is a plantderived, standardized cannabinoid-based oromucosal spray medicine for add-on treatment of moderate to severe, resistant multiple sclerosis-induced spasticity. This article reviews the current evidence for the efficacy and safety, with dizziness and fatigue as the most common treatment-related adverse events, being mostly mild to moderate in severity. Results from both randomized controlled phase III studies involving about,1600 MS patients or 1500 patient-years and recently published studies on everyday clinical practice involving more than 1000 patients or more than,1000 patient-years are presented.

Immune Responses Regulated by Cannabidiol

“…Clinical studies that have been performed have shown that Sativex has beneficial effects on spasticity, mobility, bladder function, and pain in MS patients, and is well tolerated 22,25,28,31,[168][169][170][171][172][173][174][175] ; however, there has been little focus on the neuroprotective and immunosuppressive effects of THC:CBD mixtures in MS, and so it is difficult to say at this point if the successful results observed with CBD in the animal models of MS will be observed in MS patients. For a more complete review on the effects of Sativex in MS, see Zettl et al 176 Other autoimmune disease states CBD has been shown to attenuate experimental autoimmune hepatitis, 86 experimental autoimmune myocarditis, 126 and autoimmune diabetes 123,124 in mice. There are few studies done with CBD only in human autoimmune diseases.…”

Cannabinoid receptor expression in non-small cell lung cancer. Effectiveness of tetrahydrocannabinol and cannabidiol inhibiting cell proliferation and epithelial-mesenchymal transition in vitro

“…THC is a partial agonist of CB1 and CB2 receptors, and induces analgesia and muscle relaxation, suppresses emesis and stimulates appetite; however, the psychotropic activity of THC limits its clinical use [21]. CBD has greater affinity for CB2 than CB1 [22]. It also stimulates vanilloid pain receptors (VR1) and inhibits the uptake of anandamide [23].…”

“…It also stimulates vanilloid pain receptors (VR1) and inhibits the uptake of anandamide [23]. CBD has anti-inflammatory, neuroprotective, anticonvulsant, muscle-relaxant, and anti-psychotropic effects [22]. Combined used of THC and CBD confers greater benefits, as CBD enhances the effects of THC and reduces its psychotropic activity.…”

Cannabinoids for spasticity due to multiple sclerosis or paraplegia: A systematic review and meta-analysis of randomized clinical trials

“…One of them 45 is the largest multicentre observational study to date evaluating THC-CBD oromucosal spray effectiveness and tolerability in daily clinical practice, carried out in a routine outpatient setting. The other is a narrative review 46 that describes findings from both randomized controlled phase III trials and recent studies on everyday clinical practice. Intending to expand and complement the comprehension on the subject, we engaged on a systematic and meta-analytic approach on this present review.…”