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Daily Practice Managing Resistant Multiple Sclerosis Spasticity With Delta-9-Tetrahydrocannabinol: Cannabidiol Oromucosal Spray: A Systematic Review of Observational Studies
Open accessAbstract
Background/purpose: Spasticity is one of the most common symptoms in people with multiple sclerosis (MS). Conventional anti-spasticity agents have limitations in their efficacy and tolerability. Delta-9-tetrahydrocannabinol: cannabidiol (THC:CBD) spray, a cannabinoid-based medicine, is approved as an add-on therapy for MS spasticity not adequately controlled by other anti-spasticity medications. The results from randomized controlled trials (RCTs) have demonstrated a reduction in the severity of spasticity and associated symptoms. However, RCTs do not always reflect real-life outcomes. We systematically reviewed the complementary evidence from non-interventional real-world studies. Methods: A systematic literature review was conducted to identify all non-RCT publications on THC:CBD spray between 2011 and 2017. Data on study design, patient characteristics, effectiveness, and safety outcomes were extracted from those publications meeting our inclusion criteria. Results: In total, we reviewed 14 real-world publications including observational studies and treatment registries. The proportion of patients reaching the threshold of minimal clinical important difference (MCID), with at least a 20% reduction of the spasticity Numeric Rating Scale (NRS) score after 4 weeks ranged from 41.9% to 82.9%. The reduction in the mean NRS spasticity score after 4 weeks was maintained over 6-12 months. The average daily dose was five to six sprays. Delta-9-tetrahydrocannabinol: cannabidiol was well tolerated in the evaluated studies in the same way as in the RCTs. No new or unexpected adverse events or safety signals were reported in everyday clinical practice. Conclusions: The data evaluated in this systematic review provide evidence for the efficacy and safety of THC:CBD in clinical practice and confirm results obtained in RCTs.
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Benefits of cannabinoids on muscle spasticity were more evident on patient than on physician ratings.
“Benefits were more evident on patient than on physician ratings of muscle spasticity [91, 92].”
From Cannabis, cannabinoids and health: a review of evidence on risks and medical benefits (2025) · cites this paper as [91]
The Introduction identifies the NRS as patient-rated and the MAS as physician-rated. Results (Spasticity outcome; page unavailable) report improvement on both measures, but do not say the benefit was more evident on patient ratings than on physician ratings. (LLM, conf=0.84)
Experimental — accuracy not yet measuredSome cannabinoids (nabiximols, dronabinol, oral and oromucosal THC and THC/CBD, medicinal hemp) have small beneficial effects on muscle spasticity, primarily in patients with multiple sclerosis and possibly in those with spinal cord injuries and motor neuron disease.
“Some cannabinoids (nabiximols, dronabinol, oral and oromucosal THC and THC/CBD, medicinal hemp) have small beneficial effects on muscle spasticity, primarily in patients with multiple sclerosis and possibly in those with spinal cord injuries and motor neuron disease.”
From Cannabis, cannabinoids and health: a review of evidence on risks and medical benefits (2025) · cites this paper as [91]
The Introduction and Results > Spasticity outcome report improvement in multiple-sclerosis spasticity with THC:CBD oromucosal spray (nabiximols). The paper does not establish the claimed effects for the other listed cannabinoid preparations or for spinal cord injury or motor neuron disease; it also does not characterize the benefit as small. Page numbers are unavailable in our copy. (LLM, conf=0.90)
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Markovà, J., Essner, U., Akmaz, B., Marinelli, M., Trompke, C., Lentschat, A., & Vila, C. (2019) · International Journal of Neuroscience · doi:10.1080/00207454.2018.1481066 · Cited by 151
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Markovà, J., Essner, U., Akmaz, B., Marinelli, M., Trompke, C., Lentschat, A., & Vila, C. (2019) · International Journal of Neuroscience · doi:10.1080/00207454.2018.1481066 · Cited by 151
Self-citationCannabis, cannabinoids and health: a review of evidence on risks and medical benefits
Hoch, E., Volkow, N. D., Friemel, C. M., Lorenzetti, V., Freeman, T. P., & Hall, W. (2025) · European Archives of Psychiatry and Clinical Neuroscience · doi:10.1007/s00406-024-01880-2 · Cited by 139
“Benefits were more evident on patient than on physician ratings of muscle spasticity [91, 92].”
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Metadata
- Authors
- Akgün, K., Essner, U., Seydel, C., & Ziemssen, T.
- Affiliations
- University Hospital Carl Gustav Carus (DE)
- O.MEANY Consultancy GmbH, Hamburg, Germany
- Almirall (Germany) (DE)
- Corresponding author
- Essner, Ute
- Venue
- Journal of Central Nervous System Disease
- Publisher
- SAGE Publications
- Published
- 2019-01
- Volume
- 11
- Pages
- 1179573519831997-1179573519831997
- ISSN
- 1179-5735 (ISSN-L)
- PMC
- PMC6413425
- OpenAlex
- W2922483223
- Cited by
- 28
- References
- 1
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 3 · 2023: 1 · 2022: 7 · 2021: 8 · 2020: 5
- FWCI
- 0.64
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Journal of Central Nervous System Disease (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Clinical Neurology › Botulinum Toxin and Related Neurological Disorders
- Health Sciences › Medicine › Clinical Neurology › Multiple Sclerosis Research Studies
- Keywords
- multiple sclerosis, spasticity, delta-9-tetrahydrocannabinol, cannabidiol, real-world effectiveness, treatment safety, numerical rating scale, minimal clinically important difference
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