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Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.
Eur J Neurol 2007; 14(3):290-6EJ

Abstract

Symptoms relating to spasticity are common in multiple sclerosis (MS) and can be difficult to treat. We have investigated the efficacy, safety and tolerability of a standardized oromucosal whole plant cannabis-based medicine (CBM) containing delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), upon spasticity in MS. A total of 189 subjects with definite MS and spasticity were randomized to receive daily doses of active preparation (n = 124) or placebo (n = 65) in a double blind study over 6 weeks. The primary endpoint was the change in a daily subject-recorded Numerical Rating Scale of spasticity. Secondary endpoints included a measure of spasticity (Ashworth Score) and a subjective measure of spasm. The primary efficacy analysis on the intention to treat (ITT) population (n = 184) showed the active preparation to be significantly superior (P = 0.048). Secondary efficacy measures were all in favour of active preparation but did not achieve statistical significance. The responder analysis favoured active preparation, 40% of subjects achieved >30% benefit (P = 0.014). Eight withdrawals were attributed to adverse events (AEs); six were on active preparation and two on placebo. We conclude that this CBM may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS.

Authors+Show Affiliations

Department of Neurorehabilitation, Royal Berkshire and Battle NHS Trust, Reading, UK. christine.collin@rbbh-tr.nhs.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17355549

Citation

Collin, C, et al. "Randomized Controlled Trial of Cannabis-based Medicine in Spasticity Caused By Multiple Sclerosis." European Journal of Neurology, vol. 14, no. 3, 2007, pp. 290-6.
Collin C, Davies P, Mutiboko IK, et al. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol. 2007;14(3):290-6.
Collin, C., Davies, P., Mutiboko, I. K., & Ratcliffe, S. (2007). Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. European Journal of Neurology, 14(3), pp. 290-6.
Collin C, et al. Randomized Controlled Trial of Cannabis-based Medicine in Spasticity Caused By Multiple Sclerosis. Eur J Neurol. 2007;14(3):290-6. PubMed PMID: 17355549.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. AU - Collin,C, AU - Davies,P, AU - Mutiboko,I K, AU - Ratcliffe,S, AU - ,, PY - 2007/3/16/pubmed PY - 2007/5/11/medline PY - 2007/3/16/entrez SP - 290 EP - 6 JF - European journal of neurology JO - Eur. J. Neurol. VL - 14 IS - 3 N2 - Symptoms relating to spasticity are common in multiple sclerosis (MS) and can be difficult to treat. We have investigated the efficacy, safety and tolerability of a standardized oromucosal whole plant cannabis-based medicine (CBM) containing delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), upon spasticity in MS. A total of 189 subjects with definite MS and spasticity were randomized to receive daily doses of active preparation (n = 124) or placebo (n = 65) in a double blind study over 6 weeks. The primary endpoint was the change in a daily subject-recorded Numerical Rating Scale of spasticity. Secondary endpoints included a measure of spasticity (Ashworth Score) and a subjective measure of spasm. The primary efficacy analysis on the intention to treat (ITT) population (n = 184) showed the active preparation to be significantly superior (P = 0.048). Secondary efficacy measures were all in favour of active preparation but did not achieve statistical significance. The responder analysis favoured active preparation, 40% of subjects achieved >30% benefit (P = 0.014). Eight withdrawals were attributed to adverse events (AEs); six were on active preparation and two on placebo. We conclude that this CBM may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS. SN - 1468-1331 UR - https://www.unboundmedicine.com/medline/citation/17355549/abstract/Randomized_controlled_trial_of_cannabis_based_medicine_in_spasticity_caused_by_multiple_sclerosis L2 - https://doi.org/10.1111/j.1468-1331.2006.01639.x DB - PRIME DP - Unbound Medicine ER -