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Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis.

Abstract

BACKGROUND

Central pain in multiple sclerosis (MS) is common and often refractory to treatment.

METHODS

We conducted a single-center, 5-week (1-week run-in, 4-week treatment), randomized, double-blind, placebo-controlled, parallel-group trial in 66 patients with MS and central pain states (59 dysesthetic, seven painful spasms) of a whole-plant cannabis-based medicine (CBM), containing delta-9-tetrahydrocannabinol:cannabidiol (THC:CBD) delivered via an oromucosal spray, as adjunctive analgesic treatment. Each spray delivered 2.7 mg of THC and 2.5 of CBD, and patients could gradually self-titrate to a maximum of 48 sprays in 24 hours.

RESULTS

Sixty-four patients (97%) completed the trial, 34 received CBM. In week 4, the mean number of daily sprays taken of CBM (n = 32) was 9.6 (range 2 to 25, SD = 6.0) and of placebo (n = 31) was 19.1 (range 1 to 47, SD = 12.9). Pain and sleep disturbance were recorded daily on an 11-point numerical rating scale. CBM was superior to placebo in reducing the mean intensity of pain (CBM mean change -2.7, 95% CI: -3.4 to -2.0, placebo -1.4 95% CI: -2.0 to -0.8, comparison between groups, p = 0.005) and sleep disturbance (CBM mean change -2.5, 95% CI: -3.4 to -1.7, placebo -0.8, 95% CI: -1.5 to -0.1, comparison between groups, p = 0.003). CBM was generally well tolerated, although more patients on CBM than placebo reported dizziness, dry mouth, and somnolence. Cognitive side effects were limited to long-term memory storage.

CONCLUSIONS

Cannabis-based medicine is effective in reducing pain and sleep disturbance in patients with multiple sclerosis related central neuropathic pain and is mostly well tolerated.

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  • Authors+Show Affiliations

    ,

    Walton Centre for Neurology and Neurosurgery, University of Liverpool, Liverpool, United Kingdom. djrdjr@doctors.org.uk

    , ,

    Source

    Neurology 65:6 2005 Sep 27 pg 812-9

    MeSH

    Administration, Oral
    Adult
    Aged
    Analgesics
    Cannabinoids
    Central Nervous System
    Disorders of Excessive Somnolence
    Dizziness
    Dose-Response Relationship, Drug
    Double-Blind Method
    Dronabinol
    Female
    Humans
    Male
    Memory Disorders
    Middle Aged
    Multiple Sclerosis
    Pain Measurement
    Pain Threshold
    Pain, Intractable
    Phytotherapy
    Placebos
    Plant Preparations
    Sleep Wake Disorders
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    16186518

    Citation

    Rog, David J., et al. "Randomized, Controlled Trial of Cannabis-based Medicine in Central Pain in Multiple Sclerosis." Neurology, vol. 65, no. 6, 2005, pp. 812-9.
    Rog DJ, Nurmikko TJ, Friede T, et al. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology. 2005;65(6):812-9.
    Rog, D. J., Nurmikko, T. J., Friede, T., & Young, C. A. (2005). Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology, 65(6), pp. 812-9.
    Rog DJ, et al. Randomized, Controlled Trial of Cannabis-based Medicine in Central Pain in Multiple Sclerosis. Neurology. 2005 Sep 27;65(6):812-9. PubMed PMID: 16186518.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. AU - Rog,David J, AU - Nurmikko,Turo J, AU - Friede,Tim, AU - Young,Carolyn A, PY - 2005/9/28/pubmed PY - 2006/3/11/medline PY - 2005/9/28/entrez SP - 812 EP - 9 JF - Neurology JO - Neurology VL - 65 IS - 6 N2 - BACKGROUND: Central pain in multiple sclerosis (MS) is common and often refractory to treatment. METHODS: We conducted a single-center, 5-week (1-week run-in, 4-week treatment), randomized, double-blind, placebo-controlled, parallel-group trial in 66 patients with MS and central pain states (59 dysesthetic, seven painful spasms) of a whole-plant cannabis-based medicine (CBM), containing delta-9-tetrahydrocannabinol:cannabidiol (THC:CBD) delivered via an oromucosal spray, as adjunctive analgesic treatment. Each spray delivered 2.7 mg of THC and 2.5 of CBD, and patients could gradually self-titrate to a maximum of 48 sprays in 24 hours. RESULTS: Sixty-four patients (97%) completed the trial, 34 received CBM. In week 4, the mean number of daily sprays taken of CBM (n = 32) was 9.6 (range 2 to 25, SD = 6.0) and of placebo (n = 31) was 19.1 (range 1 to 47, SD = 12.9). Pain and sleep disturbance were recorded daily on an 11-point numerical rating scale. CBM was superior to placebo in reducing the mean intensity of pain (CBM mean change -2.7, 95% CI: -3.4 to -2.0, placebo -1.4 95% CI: -2.0 to -0.8, comparison between groups, p = 0.005) and sleep disturbance (CBM mean change -2.5, 95% CI: -3.4 to -1.7, placebo -0.8, 95% CI: -1.5 to -0.1, comparison between groups, p = 0.003). CBM was generally well tolerated, although more patients on CBM than placebo reported dizziness, dry mouth, and somnolence. Cognitive side effects were limited to long-term memory storage. CONCLUSIONS: Cannabis-based medicine is effective in reducing pain and sleep disturbance in patients with multiple sclerosis related central neuropathic pain and is mostly well tolerated. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/16186518/Randomized_controlled_trial_of_cannabis_based_medicine_in_central_pain_in_multiple_sclerosis_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&pmid=16186518 DB - PRIME DP - Unbound Medicine ER -