Study: Benefits of Cannabinoids Extend Beyond Spasticity in Those With Multiple Sclerosis

A new study has “confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients”. The study, titled Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study, was published in the journal Neurological Sciences


“The approval of 9-δ-tetrahydocannabinol (THC)+cannabidiol (CBD) oromucosal spray (Sativex®) in Italy as an add-on medication for the management of moderate to severe spasticity in multiple sclerosis (MS) has provided a new opportunity for MS patients with drug-resistant spasticity”, states the study. “We aimed to investigate the improvement of MS spasticity-related symptoms in a large cohort of patients with moderate to severe spasticity in daily clinical practice.”

Out of 1615 enrolled patients, 1432 reached the end of the first month trial period (T1). Of these, “1010 patients (70.5%) reached a ≥ 20% NRS score reduction compared with baseline (initial responders; IR). We found that 627 (43.8% of 1432) patients showed an improvement in at least one spasticity-related symptom (SRSr group), 543 (86.6%) of them belonging to the IR group and 84 (13.4%) to the spasticity NRS non-responders group.”

Based on this, researchers state that: “Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients.”

The study’s full abstract can be found below:

INTRODUCTION:

The approval of 9-δ-tetrahydocannabinol (THC)+cannabidiol (CBD) oromucosal spray (Sativex®) in Italy as an add-on medication for the management of moderate to severe spasticity in multiple sclerosis (MS) has provided a new opportunity for MS patients with drug-resistant spasticity. We aimed to investigate the improvement of MS spasticity-related symptoms in a large cohort of patients with moderate to severe spasticity in daily clinical practice.

MATERIALS AND METHODS:

MS patients with drug-resistant spasticity were recruited from 30 Italian MS centers. All patients were eligible for THC:CBD treatment according to the approved label: ≥ 18 years of age, at least moderate spasticity (MS spasticity numerical rating scale [NRS] score ≥ 4) and not responding to the common antispastic drugs. Patients were evaluated at baseline (T0) and after 4 weeks of treatment (T1) with the spasticity NRS scale and were also asked about meaningful improvements in 6 key spasticity-related symptoms.

RESULTS:

Out of 1615 enrolled patients, 1432 reached the end of the first month trial period (T1). Of these, 1010 patients (70.5%) reached a ≥ 20% NRS score reduction compared with baseline (initial responders; IR). We found that 627 (43.8% of 1432) patients showed an improvement in at least one spasticity-related symptom (SRSr group), 543 (86.6%) of them belonging to the IR group and 84 (13.4%) to the spasticity NRS non-responders group.

CONCLUSION:

Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients.

 

The study was conducted by researchers from the following locations:

  • Department “G.F. Ingrassia”, section of Neurosciences, University of Catania, Catania, Italy.patti@unict.it.
  • Department “G.F. Ingrassia”, section of Neurosciences, University of Catania, Catania, Italy.3Department of Neurology, ASL
  • Genovese, and Department of Rehabilitation, ML Novarese Hospital Moncrivello, Genoa, Italy.
  • Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Neurology, University of Verona, Verona, Italy.
  • Neurorehabilitation Unit, Department of Neurology, Neurology Institute C. Mondino, Pavia, Italy.
  • Multiple Sclerosis Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Neurology Operating Unit and Multiple Sclerosis Center, Provincial Health Authority of Cosenza, Cosenza, Italy.
  • Synaptic Immunopathology Lab, Department of Systems Medicine, Tor Vergata University, Rome, Italy.
  • Neurology Unit, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.
  • Department Neuroscience and Mental Health, Multiple Sclerosis Centre, Health and Science City University Hospital of Turin, Turin, Italy.
  • Department of Experimental and Clinical Medicine, Neurological Clinic, Marche Polytechnic University, Ancona, Italy.
  • Demyelinating Diseases Centre, Foggia Hospital, Foggia, Italy.
  • Multiple Sclerosis Centre, San Camillo-Forlanini Hospital, Rome, Italy.
  • Multiple Sclerosis Center, Medicine Department, Fidenza Hospital, Fidenza, PR, Italy.
  • Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy.
  • Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II, Naples, Italy.
  • Department of Neurology, Ospedale Cardarelli, Naples, Italy.
  • Neurobiology Unit, Neurologia 2, CReSM (Regional Referring Center Multiple Sclerosis), San Luigi Gonzaga University Hospital & Neuroscience Institute Cavalieri Ottolenghi (NICO), Orbassano, TO, Italy.
  • Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
  • Multiple Sclerosis Centre, University Hospital Pisa, Pisa, Italy.
  • Multiple Sclerosis Center of Department of Neurology and Psychiatry of Sapienza, University of Rome, Rome, Italy.
  • Department of NEUROFARBA, University of Florence, Florence, Italy.
  • Multiple Sclerosis Centre, IRCCS-Bonino Pulejo Centre, Messina, Italy.
  • Neuroimmunology Unit, Villa Sofia-Cervello Hospital, Palermo, Italy.
  • Department of Clinical and Experimental Medicine, Multiple Sclerosis Center, II Division of Neurology, University of Campania “Luigi Vanvitelli”, Naples, Italy.
  • Department of Medical Sciences and Public Health, Multiple Sclerosis Center, University of Cagliari, Cagliari, Italy.
  • Azienda Ospedaliera di Rilievo Nazionale, San Giuseppe Moscati, Avellino, Italy.
  • Multiple Sclerosis Center, Unit of Motor Neurorehabilitation, IRCCS Santa Maria Nascente, Fondazione Don Gnocchi, Milan, Italy.
  • Institute of Neurology, University “Magna Graecia”, Germaneto, Catanzaro, Italy.
  • Multiple Sclerosis Center, ASST della Valle Olona, Gallarate Hospital, Gallarate, VA, Italy.

 

More information on this study can be found by clicking here.

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