Evidence map›Paper›PMID 26289497›Full record

Trial reportJournal of neurology2015

Sativex(®) and clinical-neurophysiological measures of spasticity in progressive multiple sclerosis.

Letizia Leocani, Arturo Nuara, Elise Houdayer, Irene Schiavetti, Ubaldo Del Carro, Stefano Amadio, Laura Straffi, Paolo Rossi, Vittorio Martinelli, Carlos Vila and 2 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 8 pooled it
4.0field-weighted citation impact, top 6% 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

27 citing papers in PubMed, 8 syntheses or guidelines pooled it, 62 citations in OpenAlex.

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  7. Analgesic Effects of Cannabinoids for Chronic Non-cancer Pain: a Systematic Review and Meta-Analysis with Meta-Regression.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2020
    Pooled it
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  18. Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
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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

12 authors at 4 institutions in 2 countries.

Letizia LeocaniNeurological Department and INSPE-Institute of Experimental Neurology, Scientific Institute Hospital San Raffaele, Via Olgettina 60, 20132, Milan, Italy. leocani.letizia@hsr.it.
Arturo NuaraNeurological Department and INSPE-Institute of Experimental Neurology, Scientific Institute Hospital San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
Elise HoudayerNeurological Department and INSPE-Institute of Experimental Neurology, Scientific Institute Hospital San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
Irene SchiavettiBiostatistics Unit, Department of Health Sciences (DISSAL), University of Genova, Genoa, Italy.
Ubaldo Del CarroNeurological Department and INSPE-Institute of Experimental Neurology, Scientific Institute Hospital San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
Stefano AmadioNeurological Department and INSPE-Institute of Experimental Neurology, Scientific Institute Hospital San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
Laura StraffiNeurological Department and INSPE-Institute of Experimental Neurology, Scientific Institute Hospital San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
Paolo RossiNeurological Department and INSPE-Institute of Experimental Neurology, Scientific Institute Hospital San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
Vittorio MartinelliNeurological Department and INSPE-Institute of Experimental Neurology, Scientific Institute Hospital San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
Carlos VilaGlobal Medical Affairs, Almirall S.A., Barcelona, Spain.
Maria Pia SormaniBiostatistics Unit, Department of Health Sciences (DISSAL), University of Genova, Genoa, Italy.
Giancarlo ComiNeurological Department and INSPE-Institute of Experimental Neurology, Scientific Institute Hospital San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
San Raffaele University of Rome · ITUniversity of Genoa · ITAlmirall (Spain) · ESVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite the proven efficacy of Sativex(®) (9-delta-tetrahydrocannabinol plus cannabidiol) oromucosal spray in reducing spasticity symptoms in multiple sclerosis (MS), little is known about the neurophysiological correlates of such effects. The aim of the study was to investigate the effects of Sativex on neurophysiological measures of spasticity (H/M ratio) and corticospinal excitability in patients with progressive MS. This was a randomized, double-blind, placebo-controlled, crossover study. Consecutive subjects with progressive MS and lower limb spasticity referred to our center were randomized to 4 weeks' treatment (including 2 weeks' titration) with Sativex or placebo, with crossover after a 2-week washout. Clinical and neurophysiological measures (H/M ratio and cortical excitability) of spasticity were assessed. The H/M ratio was the primary outcome, with sample size calculation of 40 patients. Of 44 recruited patients, 34 were analyzed due to 6 drop-outs and 4 exclusions, which lowered the power of the study to show differences between treatments. Neurophysiological measures did not differ significantly according to treatment and did not correlate significantly with clinical response. Response on the modified Ashworth scale (at least 20 % improvement) was significantly more frequent after Sativex than placebo (50 vs 23.5 %; p = 0.041; McNemar). Side effects did not differ significantly according to treatment. Our findings confirm the clinical benefit of Sativex on MS spasticity. The lack of corresponding changes in corticospinal excitability and on the monosynaptic component, of the stretch reflex, although in a limited sample size, points to the involvement of other spinal and supraspinal mechanisms in the physiopathology of spasticity in progressive MS.

Indexed as

Outcome Assessment, Health CareAdultCannabidiolCerebral CortexCross-Over StudiesDouble-Blind MethodDronabinolDrug CombinationsElectric StimulationElectromyographyEvoked Potentials, MotorFemaleHumansMaleMiddle AgedMultiple Sclerosis, Chronic ProgressiveCannabidiolDronabinolDrug CombinationsnabiximolsPlant ExtractsH-reflexMultiple sclerosisSativexSpasticityTranscranial magnetic stimulation

Identifiers

PMID26289497
OpenAlexW1181448258

What OpenQuestion holds

Textmetadata
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.