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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.
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.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org. and scroll down the Table of Contents for the September 27 issue to find the link for this article.
Disclosure: David J. Rog, BMBS, Carolyn A. Young, MD, and Turo J. Nurmikko, PhD, contributed to the conception and design of this study and the drafting and revision of the paper. Drs. Rog and Young participated in the acquisition of trial data. Dr. Friede independently analyzed the study data and contributed to the drafting and revision of the paper. Dr. Rog has accepted travel and accommodation expenses from GW Pharma to attend an Investigator's Meeting (less than $10,000) and his salary was paid from a research fund to which GW Pharma contributed (in excess of $10,000). Dr. Friede has no conflicts of interest; he is currently employed by Novartis Pharma, Basle, Switzerland. Drs. Young and Nurmikko have both received funding for research (in excess of $10,000) from GW Pharma and Dr. Nurmikko has also received an honorarium (less than $10,000) for speaking from GW Pharma.
GW Pharmaceuticals sponsored the trial, contributed to study design, provided trial medication and matching placebo and collected the data. GW Pharma Ltd. has contracted data handling and analysis to a contract research organization. The authors have received full access to the data and conducted an independent analysis. GW and Bayer Pharmaceuticals have had the opportunity to review the manuscript of the paper, but decision to publish rests with the authors.
Received January 15, 2005. Accepted in final form June 9, 2005.
Address correspondence and reprints to Dr. David J. Rog, Clinical Trials Unit, Walton Centre for Neurology and Neurosurgery, Liverpool, L9 7LJ, UK; e-mail: djrdjr{at}doctors.org.uk.
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