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Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial.

Abstract

The objective was to investigate the effectiveness of cannabis-based medicines for treatment of chronic pain associated with brachial plexus root avulsion. This condition is an excellent human model of central neuropathic pain as it represents an unusually homogenous group in terms of anatomical location of injury, pain descriptions and patient demographics. Forty-eight patients with at least one avulsed root and baseline pain score of four or more on an 11-point ordinate scale participated in a randomised, double-blind, placebo-controlled, three period crossover study. All patients had intractable symptoms regardless of current analgesic therapy. Patients entered a baseline period of 2 weeks, followed by three, 2-week treatment periods during each of which they received one of three oromucosal spray preparations. These were placebo and two whole plant extracts of Cannabis sativa L.: GW-1000-02 (Sativex), containing Delta(9)tetrahydrocannabinol (THC):cannabidiol (CBD) in an approximate 1:1 ratio and GW-2000-02, containing primarily THC. The primary outcome measure was the mean pain severity score during the last 7 days of treatment. Secondary outcome measures included pain related quality of life assessments. The primary outcome measure failed to fall by the two points defined in our hypothesis. However, both this measure and measures of sleep showed statistically significant improvements. The study medications were generally well tolerated with the majority of adverse events, including intoxication type reactions, being mild to moderate in severity and resolving spontaneously. Studies of longer duration in neuropathic pain are required to confirm a clinically relevant, improvement in the treatment of this condition.

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  • Authors+Show Affiliations

    ,

    Royal National Orthopaedic Hospital, Brockley Hill, Stanmore, Middlesex HA7 4LP, UK. johathan.berman@rnoh.nhs.uk

    ,

    Source

    Pain 112:3 2004 Dec pg 299-306

    MeSH

    Adolescent
    Adult
    Aged
    Analysis of Variance
    Brachial Plexus Neuropathies
    Cannabidiol
    Cross-Over Studies
    Double-Blind Method
    Dronabinol
    Drug Combinations
    Female
    Humans
    Male
    Middle Aged
    Pain
    Pain Measurement
    Plant Extracts
    Retrospective Studies
    Sleep
    Time Factors
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    15561385

    Citation

    Berman, Jonathan S., et al. "Efficacy of Two Cannabis Based Medicinal Extracts for Relief of Central Neuropathic Pain From Brachial Plexus Avulsion: Results of a Randomised Controlled Trial." Pain, vol. 112, no. 3, 2004, pp. 299-306.
    Berman JS, Symonds C, Birch R. Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial. Pain. 2004;112(3):299-306.
    Berman, J. S., Symonds, C., & Birch, R. (2004). Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial. Pain, 112(3), pp. 299-306.
    Berman JS, Symonds C, Birch R. Efficacy of Two Cannabis Based Medicinal Extracts for Relief of Central Neuropathic Pain From Brachial Plexus Avulsion: Results of a Randomised Controlled Trial. Pain. 2004;112(3):299-306. PubMed PMID: 15561385.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial. AU - Berman,Jonathan S, AU - Symonds,Catherine, AU - Birch,Rolfe, PY - 2003/11/03/received PY - 2004/09/05/revised PY - 2004/09/13/accepted PY - 2004/11/25/pubmed PY - 2005/5/20/medline PY - 2004/11/25/entrez SP - 299 EP - 306 JF - Pain JO - Pain VL - 112 IS - 3 N2 - The objective was to investigate the effectiveness of cannabis-based medicines for treatment of chronic pain associated with brachial plexus root avulsion. This condition is an excellent human model of central neuropathic pain as it represents an unusually homogenous group in terms of anatomical location of injury, pain descriptions and patient demographics. Forty-eight patients with at least one avulsed root and baseline pain score of four or more on an 11-point ordinate scale participated in a randomised, double-blind, placebo-controlled, three period crossover study. All patients had intractable symptoms regardless of current analgesic therapy. Patients entered a baseline period of 2 weeks, followed by three, 2-week treatment periods during each of which they received one of three oromucosal spray preparations. These were placebo and two whole plant extracts of Cannabis sativa L.: GW-1000-02 (Sativex), containing Delta(9)tetrahydrocannabinol (THC):cannabidiol (CBD) in an approximate 1:1 ratio and GW-2000-02, containing primarily THC. The primary outcome measure was the mean pain severity score during the last 7 days of treatment. Secondary outcome measures included pain related quality of life assessments. The primary outcome measure failed to fall by the two points defined in our hypothesis. However, both this measure and measures of sleep showed statistically significant improvements. The study medications were generally well tolerated with the majority of adverse events, including intoxication type reactions, being mild to moderate in severity and resolving spontaneously. Studies of longer duration in neuropathic pain are required to confirm a clinically relevant, improvement in the treatment of this condition. SN - 0304-3959 UR - https://www.unboundmedicine.com/medline/citation/15561385/Efficacy_of_two_cannabis_based_medicinal_extracts_for_relief_of_central_neuropathic_pain_from_brachial_plexus_avulsion:_results_of_a_randomised_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0304-3959(04)00441-5 DB - PRIME DP - Unbound Medicine ER -