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Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study.

Abstract

OBJECTIVE

Cannabis may alleviate some symptoms associated with multiple sclerosis (MS). This study investigated the effect of an orally administered standardized Cannabis sativa plant extract in MS patients with poorly controlled spasticity.

METHODS

During their inpatient rehabilitation programme, 57 patients were enrolled in a prospective, randomized, double-blind, placebo-controlled crossover study of cannabis-extract capsules standardized to 2.5 mg tetrahydrocannabinol (THC) and 0.9 mg cannabidiol (CBD) each. Patients in group A started with a drug escalation phase from 15 to maximally 30 mg THC by 5 mg per day if well tolerated, being on active medication for 14 days before starting placebo. Patients in group B started with placebo for seven days, crossed to the active period (14 days) and closed with a three-day placebo period (active drug dose escalation and placebo sham escalation as in group A). Measures used included daily self-report of spasm frequency and symptoms, Ashworth Scale, Rivermead Mobility Index, 10-m timed walk, nine-hole peg test, paced auditory serial addition test (PASAT), and the digit span test.

RESULTS

In the 50 patients included into the intention-to-treat analysis set, there were no statistically significant differences associated with active treatment compared to placebo, but trends in favour of active treatment were seen for spasm frequency, mobility and getting to sleep. In the 37 patients (per-protocol set) who received at least 90% of their prescribed dose, improvements in spasm frequency (P = 0.013) and mobility after excluding a patient who fell and stopped walking were seen (P = 0.01). Minor adverse events were slightly more frequent and severe during active treatment, and toxicity symptoms, which were generally mild, were more pronounced in the active phase.

CONCLUSION

A standardized Cannabis sativa plant extract might lower spasm frequency and increase mobility with tolerable side effects in MS patients with persistent spasticity not responding to other drugs.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Neurologische Rehabilitations- & MS-Abteilung, Berner Klinik, Montana, Switzerland. vaney.claude@bernerklinik.ch

    , , , , , ,

    Source

    MeSH

    Administration, Oral
    Cannabidiol
    Capsules
    Cross-Over Studies
    Double-Blind Method
    Dronabinol
    Humans
    Movement
    Multiple Sclerosis
    Muscle Spasticity
    Sleep

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    15327040

    Citation

    Vaney, C, et al. "Efficacy, Safety and Tolerability of an Orally Administered Cannabis Extract in the Treatment of Spasticity in Patients With Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled, Crossover Study." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 10, no. 4, 2004, pp. 417-24.
    Vaney C, Heinzel-Gutenbrunner M, Jobin P, et al. Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study. Mult Scler. 2004;10(4):417-24.
    Vaney, C., Heinzel-Gutenbrunner, M., Jobin, P., Tschopp, F., Gattlen, B., Hagen, U., ... Reif, M. (2004). Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study. Multiple Sclerosis (Houndmills, Basingstoke, England), 10(4), pp. 417-24.
    Vaney C, et al. Efficacy, Safety and Tolerability of an Orally Administered Cannabis Extract in the Treatment of Spasticity in Patients With Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled, Crossover Study. Mult Scler. 2004;10(4):417-24. PubMed PMID: 15327040.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study. AU - Vaney,C, AU - Heinzel-Gutenbrunner,M, AU - Jobin,P, AU - Tschopp,F, AU - Gattlen,B, AU - Hagen,U, AU - Schnelle,M, AU - Reif,M, PY - 2004/8/26/pubmed PY - 2005/2/9/medline PY - 2004/8/26/entrez SP - 417 EP - 24 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult. Scler. VL - 10 IS - 4 N2 - OBJECTIVE: Cannabis may alleviate some symptoms associated with multiple sclerosis (MS). This study investigated the effect of an orally administered standardized Cannabis sativa plant extract in MS patients with poorly controlled spasticity. METHODS: During their inpatient rehabilitation programme, 57 patients were enrolled in a prospective, randomized, double-blind, placebo-controlled crossover study of cannabis-extract capsules standardized to 2.5 mg tetrahydrocannabinol (THC) and 0.9 mg cannabidiol (CBD) each. Patients in group A started with a drug escalation phase from 15 to maximally 30 mg THC by 5 mg per day if well tolerated, being on active medication for 14 days before starting placebo. Patients in group B started with placebo for seven days, crossed to the active period (14 days) and closed with a three-day placebo period (active drug dose escalation and placebo sham escalation as in group A). Measures used included daily self-report of spasm frequency and symptoms, Ashworth Scale, Rivermead Mobility Index, 10-m timed walk, nine-hole peg test, paced auditory serial addition test (PASAT), and the digit span test. RESULTS: In the 50 patients included into the intention-to-treat analysis set, there were no statistically significant differences associated with active treatment compared to placebo, but trends in favour of active treatment were seen for spasm frequency, mobility and getting to sleep. In the 37 patients (per-protocol set) who received at least 90% of their prescribed dose, improvements in spasm frequency (P = 0.013) and mobility after excluding a patient who fell and stopped walking were seen (P = 0.01). Minor adverse events were slightly more frequent and severe during active treatment, and toxicity symptoms, which were generally mild, were more pronounced in the active phase. CONCLUSION: A standardized Cannabis sativa plant extract might lower spasm frequency and increase mobility with tolerable side effects in MS patients with persistent spasticity not responding to other drugs. SN - 1352-4585 UR - https://www.unboundmedicine.com/medline/citation/15327040/Efficacy_safety_and_tolerability_of_an_orally_administered_cannabis_extract_in_the_treatment_of_spasticity_in_patients_with_multiple_sclerosis:_a_randomized_double_blind_placebo_controlled_crossover_study_ L2 - http://journals.sagepub.com/doi/full/10.1191/1352458504ms1048oa?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -