Evidence map›Paper›PMID 35590453›Full record

ArticleEuropean journal of neurology2022

A real-world evidence study of nabiximols in multiple sclerosis patients with resistant spasticity: Analysis in relation to the newly described 'spasticity-plus syndrome'.

Francesco Patti, Clara Grazia Chisari, Óscar Fernández, Jorge Sarroca, Elena Ferrer-Picón, Francisco Hernández Vicente, Carlos Vila Silván

Open access · hybridAbstract read
In one paragraph

Article in European journal of neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. A proof-of-concept study on the effectiveness of botulinum toxin on spasticity plus syndrome in multiple sclerosis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Article
  6. Nabiximols improves sleep architecture in multiple sclerosis: A prospective polysomnographic study.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Article
  7. Review
  8. Review
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  13. Observational
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  15. Article
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  17. Cannabinoids for spasticity in patients with multiple sclerosis: A systematic review and meta-analysis.Multiple sclerosis journal - experimental, translational and clinical
    Review
  18. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Francesco PattiSection of Neurosciences, Department "GF Ingrassia", University of Catania, Catania, Italy.ORCID 0000-0002-6923-0846
Clara Grazia ChisariSection of Neurosciences, Department "GF Ingrassia", University of Catania, Catania, Italy.ORCID 0000-0003-1607-543X
Óscar FernándezDepartment of Pharmacology, Faculty of Medicine, Institute of Biomedical Research of Malaga (IBIMA), Regional University Hospital, University of Malaga, Málaga, Spain.ORCID 0000-0003-3696-789X
Jorge SarrocaMedical Department, Almirall S.A., Barcelona, Spain.
Elena Ferrer-PicónMedical Department, Almirall S.A., Barcelona, Spain.
Francisco Hernández VicenteGlobal Clinical Statistics, Almirall S.A., Barcelona, Spain.
Carlos Vila SilvánGlobal Medical Affairs, Almirall S.A., Barcelona, Spain.
Almirall (Spain) · ESUniversity of Catania · ITInstituto de Investigación Biomédica de Málaga · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeNabiximols is a therapeutic option for patients with multiple sclerosis (MS) spasticity whose symptoms are poorly controlled by conventional oral first-line medications. This study aimed to assess the relationship between changes in spasticity severity (measured on the 0-10 numeric rating scale [NRS]) and the presence of associated symptoms in patients treated with nabiximols, and to investigate the presence of the newly described 'spasticity-plus syndrome'.

methodsWe analyzed real-world data from the Italian Medicines Agency e-Registry on 1138 patients with MS spasticity who began treatment with nabiximols. Evaluation time points were baseline, 4 weeks, and 3, 6, 12 and 18 months after treatment start.

resultsCommon symptoms associated with MS spasticity in this cohort were pain (38.4% at baseline), sleep disturbances (32.7%), and spasms/cramps (28.5%). Pain was frequently clustered with sleep disturbances (57.2% of pain cases) and spasms/cramps (43.9%). Approximately one-third of patients with data at all evaluation time points maintained treatment at 18 months. Nabiximols reduced the baseline mean spasticity 0-10 NRS score by 24.6% at Week 4, and by 33.9% at 18 months in treatment continuers. Nabiximols resolved a range of MS spasticity-associated symptoms at Week 4, and after 18 months in treatment continuers.

conclusionThis real-world analysis supports the concept of a spasticity-plus syndrome and suggests that nabiximols can favorably impact a range of spasticity-associated symptoms.

Indexed as

Central Nervous System DiseasesMultiple SclerosisCannabidiolDronabinolDrug CombinationsHumansMuscle CrampMuscle SpasticityPainSpasmTreatment OutcomeCannabidiolDronabinolDrug Combinationsnabiximolse-Registry analysismultiple sclerosisnabiximolsspasticity-plus syndromespasticity-related symptoms

Identifiers

PMID35590453
PMCPMC9539865
OpenAlexW4280558889

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.