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Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial.

Abstract

BACKGROUND

Multiple sclerosis is associated with muscle stiffness, spasms, pain, and tremor. Much anecdotal evidence suggests that cannabinoids could help these symptoms. Our aim was to test the notion that cannabinoids have a beneficial effect on spasticity and other symptoms related to multiple sclerosis.

METHODS

We did a randomised, placebo-controlled trial, to which we enrolled 667 patients with stable multiple sclerosis and muscle spasticity. 630 participants were treated at 33 UK centres with oral cannabis extract (n=211), Delta9-tetrahydrocannabinol (Delta9-THC; n=206), or placebo (n=213). Trial duration was 15 weeks. Our primary outcome measure was change in overall spasticity scores, using the Ashworth scale. Analysis was by intention to treat.

FINDINGS

611 of 630 patients were followed up for the primary endpoint. We noted no treatment effect of cannabinoids on the primary outcome (p=0.40). The estimated difference in mean reduction in total Ashworth score for participants taking cannabis extract compared with placebo was 0.32 (95% CI -1.04 to 1.67), and for those taking Delta9-THC versus placebo it was 0.94 (-0.44 to 2.31). There was evidence of a treatment effect on patient-reported spasticity and pain (p=0.003), with improvement in spasticity reported in 61% (n=121, 95% CI 54.6-68.2), 60% (n=108, 52.5-66.8), and 46% (n=91, 39.0-52.9) of participants on cannabis extract, Delta9-THC, and placebo, respectively.

INTERPRETATION

Treatment with cannabinoids did not have a beneficial effect on spasticity when assessed with the Ashworth scale. However, though there was a degree of unmasking among the patients in the active treatment groups, objective improvement in mobility and patients' opinion of an improvement in pain suggest cannabinoids might be clinically useful.

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  • Authors+Show Affiliations

    ,

    Peninsula Medical School, Plymouth, UK. john.zajicek@phnt.swest.nhs.uk

    , , , , , ,

    Source

    Lancet (London, England) 362:9395 2003 Nov 08 pg 1517-26

    MeSH

    Cannabidiol
    Cannabinoids
    Dronabinol
    Female
    Humans
    Locomotion
    Male
    Middle Aged
    Multiple Sclerosis
    Muscle Spasticity
    Outcome Assessment (Health Care)
    Physical Examination
    Placebos
    Secondary Prevention
    Treatment Outcome
    United Kingdom
    Walking

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    14615106

    Citation

    Zajicek, John, et al. "Cannabinoids for Treatment of Spasticity and Other Symptoms Related to Multiple Sclerosis (CAMS Study): Multicentre Randomised Placebo-controlled Trial." Lancet (London, England), vol. 362, no. 9395, 2003, pp. 1517-26.
    Zajicek J, Fox P, Sanders H, et al. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet. 2003;362(9395):1517-26.
    Zajicek, J., Fox, P., Sanders, H., Wright, D., Vickery, J., Nunn, A., & Thompson, A. (2003). Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet (London, England), 362(9395), pp. 1517-26.
    Zajicek J, et al. Cannabinoids for Treatment of Spasticity and Other Symptoms Related to Multiple Sclerosis (CAMS Study): Multicentre Randomised Placebo-controlled Trial. Lancet. 2003 Nov 8;362(9395):1517-26. PubMed PMID: 14615106.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. AU - Zajicek,John, AU - Fox,Patrick, AU - Sanders,Hilary, AU - Wright,David, AU - Vickery,Jane, AU - Nunn,Andrew, AU - Thompson,Alan, AU - ,, PY - 2003/11/15/pubmed PY - 2004/2/5/medline PY - 2003/11/15/entrez SP - 1517 EP - 26 JF - Lancet (London, England) JO - Lancet VL - 362 IS - 9395 N2 - BACKGROUND: Multiple sclerosis is associated with muscle stiffness, spasms, pain, and tremor. Much anecdotal evidence suggests that cannabinoids could help these symptoms. Our aim was to test the notion that cannabinoids have a beneficial effect on spasticity and other symptoms related to multiple sclerosis. METHODS: We did a randomised, placebo-controlled trial, to which we enrolled 667 patients with stable multiple sclerosis and muscle spasticity. 630 participants were treated at 33 UK centres with oral cannabis extract (n=211), Delta9-tetrahydrocannabinol (Delta9-THC; n=206), or placebo (n=213). Trial duration was 15 weeks. Our primary outcome measure was change in overall spasticity scores, using the Ashworth scale. Analysis was by intention to treat. FINDINGS: 611 of 630 patients were followed up for the primary endpoint. We noted no treatment effect of cannabinoids on the primary outcome (p=0.40). The estimated difference in mean reduction in total Ashworth score for participants taking cannabis extract compared with placebo was 0.32 (95% CI -1.04 to 1.67), and for those taking Delta9-THC versus placebo it was 0.94 (-0.44 to 2.31). There was evidence of a treatment effect on patient-reported spasticity and pain (p=0.003), with improvement in spasticity reported in 61% (n=121, 95% CI 54.6-68.2), 60% (n=108, 52.5-66.8), and 46% (n=91, 39.0-52.9) of participants on cannabis extract, Delta9-THC, and placebo, respectively. INTERPRETATION: Treatment with cannabinoids did not have a beneficial effect on spasticity when assessed with the Ashworth scale. However, though there was a degree of unmasking among the patients in the active treatment groups, objective improvement in mobility and patients' opinion of an improvement in pain suggest cannabinoids might be clinically useful. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/14615106/Cannabinoids_for_treatment_of_spasticity_and_other_symptoms_related_to_multiple_sclerosis__CAMS_study_:_multicentre_randomised_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(03)14738-1 DB - PRIME DP - Unbound Medicine ER -