Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice

Vermersch, Patrick; Trojano, María

doi:10.1159/000449413

Cited by 46 publications

(49 citation statements)

References 15 publications

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“…These studies demonstrated a meaningful reduction on physician‐judged relief of resistant spasticity in 75 per cent of patients after 1 month of treatment . There was improved spasticity scores and spasticity‐related symptoms at 3 months . The lack of a treatment comparison limits interpretation.…”

Section: Resultsmentioning

confidence: 98%

“…Two large ( n =334 and n =433) multisite prospective observational studies were conducted using the same protocol . They examined the effects of nabiximols on spasticity in patients with multiple sclerosis .…”

Section: Resultsmentioning

confidence: 99%

“…22 Two large (n=334 and n=433) multisite prospective observational studies were conducted using the same protocol. 24,25 They examined the effects of nabiximols on spasticity in patients with multiple sclerosis. 24,25 These studies demonstrated a meaningful reduction on physicianjudged relief of resistant spasticity in 75 per cent of patients after 1 month of treatment.…”

Section: Studies In Adult Patients With Multiple Sclerosis Observatiomentioning

confidence: 99%

“…24,25 They examined the effects of nabiximols on spasticity in patients with multiple sclerosis. 24,25 These studies demonstrated a meaningful reduction on physicianjudged relief of resistant spasticity in 75 per cent of patients after 1 month of treatment. 25 There was improved spasticity scores and spasticity-related symptoms at 3 months.…”

Section: Studies In Adult Patients With Multiple Sclerosis Observatiomentioning

confidence: 99%

“…25 There was improved spasticity scores and spasticity-related symptoms at 3 months. 24 The lack of a treatment comparison limits interpretation.…”

Section: Studies In Adult Patients With Multiple Sclerosis Observatiomentioning

confidence: 99%

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Cannabinoids for the treatment of spasticity

Nielsen

Murnion

Campbell

et al. 2019

Develop Med Child Neuro

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This review summarizes studies that examined the effectiveness of cannabinoids in treating spasticity, with a focus on understanding the relevance of the existing evidence to paediatric populations. MEDLINE, Embase, PsycINFO, and the Cochrane Library were searched to identify studies that examined the use of cannabinoids in spasticity. We identified 32 studies in adult and paediatric populations. Results were summarized by condition, with adult and paediatric studies considered separately. There is evidence from randomized controlled clinical trials that cannabinoids are more effective than placebo in reducing symptoms of spasticity in adults with multiple sclerosis. Most positive effects were based on patient‐rated rather than clinician‐rated measures, were modest in size, and should be considered in the context of the narrow therapeutic index of cannabinoids for spasticity and adverse effects. There were comparatively few, and no large studies, of spasticity in conditions other than multiple sclerosis. Few studies have been conducted in paediatric populations. Paediatric studies of spasticity provide low quality evidence and are inadequate to inform clinical practice. Cannabinoids have modest efficacy in reducing muscle spasticity in adults with multiple sclerosis. There is limited evidence of efficacy for cannabinoid use in other conditions, particularly in paediatric populations. Studies in paediatric populations have been of low quality and are insufficient to inform clinical practice.

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Section: Resultsmentioning

confidence: 98%

Section: Resultsmentioning

confidence: 99%

Section: Studies In Adult Patients With Multiple Sclerosis Observatiomentioning

confidence: 99%

Section: Studies In Adult Patients With Multiple Sclerosis Observatiomentioning

confidence: 99%

“…25 There was improved spasticity scores and spasticity-related symptoms at 3 months. 24 The lack of a treatment comparison limits interpretation.…”

Section: Studies In Adult Patients With Multiple Sclerosis Observatiomentioning

confidence: 99%

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Cannabinoids for the treatment of spasticity

Nielsen

Murnion

Campbell

et al. 2019

Develop Med Child Neuro

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Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria

Guger¹,

Hatschenberger²,

Leutmezer

2023

Brain and Behavior

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Background and purpose Randomized controlled trials and observational studies of nabiximols oromucosal spray in patients with multiple sclerosis (MS) spasticity have shown improvement in a range of associated symptoms (pain, spasms, fatigue, bladder dysfunction, and sleep disturbances). This study evaluated the effectiveness and tolerability of add‐on nabiximols in the routine management of patients with MS spasticity in Austria, with a focus on spasticity‐associated symptoms. Methods This was an open, prospective, multicenter, observational, non‐interventional study of patients with MS spasticity receiving add‐on treatment with nabiximols oromucosal spray. Main endpoints were patient‐reported changes from baseline in the frequency (counts) or severity (mean Numerical Rating Scale [NRS] scores) of spasticity‐associated symptoms, and patient‐reported changes from baseline in impairment of daily activities due to spasticity, after 1 and 3 months of nabiximols treatment. No analyses were conducted for statistical significance. Results There were 55 patients in the effectiveness population, and 62 in the safety population. Patients reported clinically relevant reductions from baseline to month 3 in the average number of spasms/day (−68.2%) and number of urinary incontinence episodes (−69.3%) in the week prior to the clinic visit, and reductions in mean 0−10 NRS scores for sleep impairment (−47.2%), fatigue (−26.4%), pain (40.4%), and spasticity severity (39.0%). There was no change from baseline in daily activity impairment due to spasticity. The majority of patients were at least partly satisfied with add‐on nabiximols for spasticity‐associated symptoms. There were 31 adverse events (27 treatment related) reported in 19 patients, with no new safety signals. Conclusions Add‐on nabiximols improved the severity of MS spasticity and a range of spasticity‐associated symptoms during real‐world use in Austria. Nabiximols is an option for patients with MS spasticity who fail first‐line oral antispasticity treatment.

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Non‐psychotropic Cannabis sativa L. phytocomplex modulates microglial inflammatory response through CB2 receptors‐, endocannabinoids‐, and NF‐κB‐mediated signaling

Borgonetti

Benatti

Governa

et al. 2022

Phytotherapy Research

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Cannabis sativa L. is increasingly emerging for its protective role in modulating neuroinflammation, a complex process orchestrated among others by microglia, the resident immune cells of the central nervous system. Phytocannabinoids, especially cannabidiol (CBD), terpenes, and other constituents trigger several upstream and downstream microglial intracellular pathways. Here, we investigated the molecular mechanisms of a CBD‐ and terpenes‐enriched C. sativa extract (CSE) in an in vitro model of neuroinflammation. We evaluated the effect of CSE on the inflammatory response induced by exposure to lipopolysaccharide (LPS) in BV‐2 microglial cells, compared with CBD and β‐caryophyllene (CAR), CB2 receptors (CB2r) inverse and full agonist, respectively. The LPS‐induced upregulation of the pro‐inflammatory cytokines IL‐1β, IL‐6, and TNF‐α was significantly attenuated by CSE and only partially by CBD, whereas CAR was ineffective. In BV‐2 cells, these anti‐inflammatory effects exerted by CSE phytocomplex were only partially dependent on CB2r modulation and they were mediated by the regulation of enzymes responsible for the endocannabinoids metabolism, by the inhibition of reactive oxygen species release and the modulation of JNK/p38 cascade with consequent NF‐κB p65 nuclear translocation suppression. Our data suggest that C. sativa phytocomplex and its multitarget mechanism could represent a novel therapeutic strategy for neuroinflammatory‐related diseases.

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Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice

Cited by 46 publications

References 15 publications

Cannabinoids for the treatment of spasticity

Cannabinoids for the treatment of spasticity

Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria

Non‐psychotropic Cannabis sativa L. phytocomplex modulates microglial inflammatory response through CB2 receptors‐, endocannabinoids‐, and NF‐κB‐mediated signaling

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