2,381
Views
2
CrossRef citations to date
0
Altmetric
Systematic Review

A systematic review of European regional and national guidelines: a focus on the recommended use of nabiximols in the management of spasticity in multiple sclerosis

, , , &
Pages 499-511 | Received 13 Apr 2022, Accepted 05 May 2022, Published online: 01 Jun 2022

References

  • Fernandez O, Costa-Frossard L, Martínez-Ginés ML, et al. Integrated management of multiple sclerosis spasticity and associated symptoms using the spasticity-plus syndrome concept: results of a structured specialists’ discussion using the workmat(®) methodology. Front Neurol. 2021;12:722801. PubMed PMID: 34646229; PubMed Central PMCID: PMCPMC8503561. eng.
  • Rizzo MA, Hadjimichael OC, Preiningerova J, et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004Oct;10(5):589–595. PubMed PMID: 15471378; eng.
  • Kister I, Bacon TE, Chamot E, et al. Natural history of multiple sclerosis symptoms. Int J MS Care. 2013 Fall;15(3):146–158. PubMed PMID: 24453777; PubMed Central PMCID: PMCPMC3883021. eng.
  • Svensson J, Borg S, Nilsson P. Costs and quality of life in multiple sclerosis patients with spasticity. Acta Neurol Scand. 2014Jan;129(1):13–20. PubMed PMID: 23683163; eng.
  • Etoom M, Khraiwesh Y, Lena F, et al. Effectiveness of physiotherapy interventions on spasticity in people with multiple sclerosis: a systematic review and meta-analysis. Am J Phys Med Rehabil. 2018Nov;9711:793–807. PubMed PMID: 29794531; eng.
  • Khan F, Amatya B, Bensmail D, et al. Non-pharmacological interventions for spasticity in adults: an overview of systematic reviews. Ann Phys Rehabil Med. 2019Jul;624:265–273. PubMed PMID: 29042299; eng.
  • Beard S, Hunn A, Wight J. Treatments for spasticity and pain in multiple sclerosis: a systematic review. Health Technol Assess. 2003;7(40):iii, ix–x, 1–111. PubMed PMID: 14636486; eng.
  • Novotna A, Mares J, Ratcliffe S, et al. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex((®))), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol. 2011Sep;189:1122-1131. PubMed PMID: 21362108; eng.
  • Markovà J, Essner U, Akmaz B, et al. Sativex(®) as add-on therapy vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial. Int J Neurosci. 2019Feb;1292:119–128. PubMed PMID: 29792372; eng.
  • Patti F, Messina S, Solaro C, et al. Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity. J Neurol Neurosurg Psychiatry. 2016Sep;879:944–951. PubMed PMID: 27160523; PubMed Central PMCID: PMCPMC5013116. eng
  • Penn RD, Savoy SM, Corcos D, et al. Intrathecal baclofen for severe spinal spasticity. N Engl J Med. 1989 Jun 8;320(23):1517–1521. PubMed PMID: 2657424; eng.
  • Ochs G, Struppler A, Meyerson BA, et al. Intrathecal baclofen for long-term treatment of spasticity: a multi-centre study. J Neurol Neurosurg Psychiatry. 1989Aug;528:933–939. PubMed PMID: 2487035; PubMed Central PMCID: PMCPMC1031830. eng
  • Romito JW, Turner ER, Rosener JA, et al. Baclofen therapeutics, toxicity, and withdrawal: a narrative review. SAGE Open Med. 2021;9:20503121211022197. PubMed PMID: 34158937; PubMed Central PMCID: PMCPMC8182184. eng.
  • Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis. PubMed PMID: 29352526; eng, Eur J Neurol. 2018 Feb;25(2):215–237.
  • Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis: report of the guideline development, dissemination, and implementation subcommittee of the American Academy of neurology. Neurology. 2018 Apr 24;90(17):777–788. PubMed PMID: 29686116; eng.
  • Baumhackl U, Berger T, E C. ÖMSB (Österreichische Multiple Sklerose Bibliothek): evidenzbasierte Informationen zu Allen Aspekten der MS für Betroffene sowie Ärzte und Ärztinnen und Angehörige medizinischer Gesundheitsberufe [ÖMSB Austrian multiple sclerosis library: evidence-based information on all aspects of MS for those affected as well as doctors, relatives and medical health professionals]. 2020. cited2021 Sept 30]. Available from: https://www.oegn.at/wp-content/uploads/2020/05/OEMSB_2020.pdf
  • Solari A, Giordano A, Sastre-Garriga J, et al. EAN guideline on palliative care of people with severe, progressive multiple sclerosis. Eur J Neurol. 2020Aug;278:1510–1529. PubMed PMID: 32469447; eng
  • Society CN. Clinical standard for diagnosis and treatment of multiple sclerosis and neurimyelitis optica 2021. [cited 2021 Nov]. Available from: https://www.czech-neuro.cz/archiv/data/M/w/u/0031-rs-doporuceni.pdf
  • Rasmussen P, Jensen H. Generelt on behandling af MS-symptomatisk. 2015. [cited 2021 Sept 29]. Available from: https://neuro.dk/wordpress/nnbv/generelt-om-symptomatisk-ms-behandling/
  • Bundesausschuss G. [Decision of the Federal Joint Committee: an amendment to the medicines directive (AMRL): annex XII - resolutions on the benefit assessment of drugs with new ones active ingredients according to § 35a sgb v - extract from Cannabis sativa L., folium cum flore (Active ingredient combination from Delta-9-Tetrahydrocannabinol and cannabidiol) ( Reassessment after the deadline). BAnz AT 30112018 B6. 2018.
  • Platz T, J. Wissel, E. Donauer. Therapie des spastischen Syndroms, S2k-Leitlinie, 2018, in: deutsche Gesellschaft für Neurologie (Hrsg.), Leitlinien für Diagnostik und Therapie in der Neurologie. 2021. [cited 2021 Sept 29]. Available from: www.dgn.org/leitlinien
  • DGN, KKNMS. Guidelines for diagnosis and therapy of MS. 2014. [cited Jan 2021]. Available from: http://www.kompetenznetz-multiplesklerose.de/wp-content/uploads/2016/02/dgn-kknms_ms-ll_20140813.pdf
  • Comi G, Solari A, Leocani L, et al. Italian consensus on treatment of spasticity in multiple sclerosis. Eur J Neurol. 2020Mar;273:445–453. PubMed PMID: 31652369; eng
  • Federation of Medical Specialists. [Multiple sclerosis]. 2021. [cited Nov 2021]. Available from: https://richtlijnendatabase.nl/richtlijn/multiple_sclerose_ms/startpagina_-_multiple_sclerose_ms.html
  • Infarmed. [Public report on the evaluation of the request for the submission of medicune for human use] Relatoria publico de avaliacao do perido de comparticipacao de medicamento para uso humano: DCI – delta-9-tetrahidrocanabinol (THC PFV) + Canabidiol (CBD PFV). Prep de Fármacos Vegetais, ext Cannabis sativa. 2021. [cited 2021 Sept 30]. Available from: https://www.infarmed.pt/documents/15786/1437513/Relat%C3%B3rio±p%C3%BAblico±de±avalia%C3%A7%C3%A3o±do±medicamento±Sativex±2019/c055642c-92fe-4e84-9da6-f72f3a9c0e06?version=1.0.
  • Oreja-Guevara C, Montalban X, de Andrés C, et al. Consensus document on spasticity in patients with multiple sclerosis. Grupo de Enfermedades Desmielinizantes de la Sociedad Española de Neurología. Rev Neurol. 2013 Oct 16;57(8):359–373. PubMed PMID: 24081891; spa.
  • (AQuAS) CAfHQaA. Practice guide care clinic to people with multiple sclerosis. 2012. [cited Nov 2021]. Available from: https://aquas.gencat.cat/web/.content/minisite/aquas/publicacions/2012/pdf/gpc_esclerosi_multiple_aiaqs2012ca_completa.pdf
  • Svenska MS Sällskapet JL. Spasticitet Metodboken [Spasticity methodbook] 2019. [cited 2021 Sept 30 2021]. Available from: http://www.mssallskapet.se/wp-content/uploads/2019/03/Spasticitet.pdf
  • NICE. Multiple sclerosis: management of multiple sclerosis in primary and secondary care. CG186. 2019. [cited 2021 Sept 29]. Available from: www.nice.org.uk/guidance/cg186
  • NICE. Cannabis-based medicinal products. NICE guideline NG144. HYPERLINK “C:\Users\User\Desktop\Clients\PH Medical Communica- tions Ltd\GWP042_Sativex guidelines_narrative review www.nice.org.uk\guidance\ng144” 2019. [cited 2021 Sept 30]. Available from: www.nice.org.uk/guidance/ng144
  • Otero-Romero S, Sastre-Garriga J, Comi G, et al. Pharmacological management of spasticity in multiple sclerosis: systematic review and consensus paper. Mult Scler. 2016Oct;2211:1386–1396. PubMed PMID: 27207462; eng
  • Amatya B, Khan F, La Mantia L, et al. Non pharmacological interventions for spasticity in multiple sclerosis. Cochrane Database Syst Rev. 2013Feb;282:Cd009974. PubMed PMID: 23450612; eng
  • Farrar JT, Troxel AB, Stott C, et al. Validity, reliability, and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: a post hoc analysis of a randomized, double-blind, placebo-controlled trial. Clin Ther. 2008May;30(5):974–985. PubMed PMID: 18555944; eng
  • Amjad F, Boster A, Carod Artal J,R, et al. Post hoc analysis of nabiximols efficacy by concomitant medication use in 2 enriched placebo-controlled randomized clinical trials (RCTs). 2022; Presented at ACTRIMS, 2022 Feb 24-26; Florida, [Cited 2022 Mar 8]. Available from: https://www.abstractsonline.com/pp8/#!/10495/presentation/700
  • Grimaldi AE, De Giglio L, Haggiag S, et al. The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray). PloS one. 2019;14(7):e0219670. PubMed PMID: 31361750; PubMed Central PMCID: PMCPMC6667203. eng.
  • Yadav V, Bever C Jr., Bowen J, et al. Summary of evidence-based guideline: complementary and alternative medicine in multiple sclerosis: report of the guideline development subcommittee of the American Academy of Neurology. Neurology. 2014 Mar 25;82(12):1083–1092. PubMed PMID: 24663230; PubMed Central PMCID: PMCPMC3962995. eng.
  • Brouwers MC, Kerkvliet K, Spithoff K. The AGREE Reporting Checklist: a tool to improve reporting of clinical practice guidelines. BMJ (Clin Res Ed). 2016 Mar 8;352:i1152. PubMed PMID: 26957104; PubMed Central PMCID: PMCPMC5118873. eng.
  • Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015 Sep 15;163(6):461–464. PubMed PMID: 26259067; eng.