Cited by 336Cannabis and Cannabinoid ResearchMultiple Sclerosis Research StudiesBotulinum Toxin and Related Neurological Disorders

Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up

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Zajicek, J P·2005·Journal of Neurology, Neurosurgery & Psychiatry

Abstract

OBJECTIVE: To test the effectiveness and long term safety of cannabinoids in multiple sclerosis (MS), in a follow up to the main Cannabinoids in Multiple Sclerosis (CAMS) study. METHODS: In total, 630 patients with stable MS with muscle spasticity from 33 UK centres were randomised to receive oral Delta(9)-tetrahydrocannabinol (Delta(9)-THC), cannabis extract, or placebo in the main 15 week CAMS study. The primary outcome was change in the Ashworth spasticity scale. Secondary outcomes were the Rivermead Mobility Index, timed 10 metre walk, UK Neurological Disability Score, postal Barthel Index, General Health Questionnaire-30, and a series of nine category rating scales. Following the main study, patients were invited to continue medication, double blinded, for up to 12 months in the follow up study reported here. RESULTS: Intention to treat analysis of data from the 80% of patients followed up for 12 months showed evidence of a small treatment effect on muscle spasticity as measured by change in Ashworth score from baseline to 12 months (Delta(9)-THC mean reduction 1.82 (n = 154, 95% confidence interval (CI) 0.53 to 3.12), cannabis extract 0.10 (n = 172, 95% CI -0.99 to 1.19), placebo -0.23 (n = 176, 95% CI -1.41 to 0.94); p = 0.04 unadjusted for ambulatory status and centre, p = 0.01 adjusted). There was suggestive evidence for treatment effects of Delta(9)-THC on some aspects of disability. There were no major safety concerns. Overall, patients felt that these drugs were helpful in treating their disease. CONCLUSIONS: These data provide limited evidence for a longer term treatment effect of cannabinoids. A long term placebo controlled study is now needed to establish whether cannabinoids may have a role beyond symptom amelioration in MS.

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  • This study reported that 74% of patients in the placebo group versus 45% of patients receiving cannabinoid-based medications cited a lack of benefit as the reason for discontinuation.

    “This study reported that 74% of the patients in the placebo group, versus 45% of the patients receiving cannabinoid-based medications, cited a lack of benefit derived from experimental medication as the reason for discontinuation of the trial.145”
  • A one year double-blind, placebo-controlled follow-up study in multiple sclerosis patients demonstrated improved symptoms of pain, spasms, spasticity, sleep, shakiness, energy level, and tiredness following administration of either dronabinol or Cannador.

    “A one year double-blind, placebo-controlled follow up study in MS patients demonstrated improved symptoms of pain, spasms, spasticity, sleep, shakiness, energy level, and tiredness following administration of either dronabinol or Cannador®.145”

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Research works printed but not linked: 2

  1. Hampson AJ, Grimaldi M, Axelrod J, et al. Cannabidiol and (-)delta9- tetrahydrocannabinol are neuroprotective antioxidants. Proc Natl Acad Sci SA 1998;95:8268-73.
  2. Riazi A, Fox P, Vickery J, et al. Developing a patient-based measure of the impact of spasticity in multiple sclerosis. Multiple Sclerosis 2003;9:S151.

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Authors
Zajicek, J. P.
Affiliations
University of Plymouth (GB)
Corresponding author
Zajicek, J P
Venue
Journal of Neurology, Neurosurgery & Psychiatry
Publisher
BMJ
Published
2005-12-01
Volume
76
Issue
12
Pages
1664-1669
ISSN
0022-3050 (ISSN-L)
OpenAlex
W2031114852
Cited by
335
References
11
Citations by year
2026: 5 · 2025: 23 · 2024: 16 · 2023: 6 · 2022: 6 · 2021: 8 · 2020: 15 · 2019: 12 · 2018: 16 · 2017: 20 · 2016: 10 · 2015: 19 · 2014: 22 · 2013: 16 · 2012: 20
FWCI
14.25
Type
journal article
Language
en
Open access
Locations
  • Journal of Neurology Neurosurgery & Psychiatry (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • UCL Discovery (University College London) (submittedVersion)
  • HighWire Press Open Archive (submittedVersion)
Funders
Medical Research Council
Topics
  • Health Sciences › Medicine › Pharmacology › Cannabis and Cannabinoid Research
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
  • Health Sciences › Medicine › Neurology › Botulinum Toxin and Related Neurological Disorders
Keywords
multiple sclerosis, cannabinoids, delta-9-tetrahydrocannabinol, cannabis extracts, spasticity, long-term safety, disability, mobility (physical function), spasticity management
MeSH terms
Administration, Oral, Adolescent, Adult, Cannabis, Double-Blind Method, Female, Persons with Disabilities, Humans, Male, Middle Aged, Multiple Sclerosis, Placebos, Plant Extracts, Severity of Illness Index, Treatment Outcome, Analgesics, Non-Narcotic

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