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September 26, 2005

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

September 27, 2005 issue
65 (6) 812-819

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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Information & Authors

Information

Published In

Neurology®
Volume 65Number 6September 27, 2005
Pages: 812-819
PubMed: 16186518

Publication History

Published online: September 26, 2005
Published in print: September 27, 2005

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Affiliations & Disclosures

David J. Rog, BMBS
From the Walton Centre for Neurology and Neurosurgery (Drs. Rog and Young), Liverpool, University of Liverpool (Drs. Rog, Nurmikko, and Young); Pain Research Institute (Dr. Nurmikko), Liverpool; Medical Statistics Unit (Dr. Friede), Lancaster University, Lancaster, United Kingdom.
Turo J. Nurmikko, PhD
From the Walton Centre for Neurology and Neurosurgery (Drs. Rog and Young), Liverpool, University of Liverpool (Drs. Rog, Nurmikko, and Young); Pain Research Institute (Dr. Nurmikko), Liverpool; Medical Statistics Unit (Dr. Friede), Lancaster University, Lancaster, United Kingdom.
Tim Friede, PhD
From the Walton Centre for Neurology and Neurosurgery (Drs. Rog and Young), Liverpool, University of Liverpool (Drs. Rog, Nurmikko, and Young); Pain Research Institute (Dr. Nurmikko), Liverpool; Medical Statistics Unit (Dr. Friede), Lancaster University, Lancaster, United Kingdom.
Carolyn A. Young, MD
From the Walton Centre for Neurology and Neurosurgery (Drs. Rog and Young), Liverpool, University of Liverpool (Drs. Rog, Nurmikko, and Young); Pain Research Institute (Dr. Nurmikko), Liverpool; Medical Statistics Unit (Dr. Friede), Lancaster University, Lancaster, United Kingdom.

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