Sativex successfully treats neuropathic pain characterised by allodynia: A randomised, double-blind, placebo-controlled clinical trial

Nurmikko, T., Serpell, M. , Toomey, P., Hoggart, B., Morlion, B. and Haines, D. (2007) Sativex successfully treats neuropathic pain characterised by allodynia: A randomised, double-blind, placebo-controlled clinical trial. Pain, 133(1-3), pp. 210-220. (doi: 10.1016/j.pain.2007.08.028)

Abstract

Cannabinoids are known to have analgesic properties. We evaluated the effect of oro-mucosal sativex, (THC: CBD), an endo- cannabinoid system modulator, on pain and allodynia, in 125 patients with neuropathic pain of peripheral origin in a five-week, randomised, double-blind, placebo-controlled, parallel design trial. Patients remained on their existing stable analgesia. A self-titrat- ing regimen was used to optimise drug administration. Sixty-three patients were randomised to receive sativex and 62 placebo. The mean reduction in pain intensity scores (primary outcome measure) was greater in patients receiving sativex than placebo (mean adjusted scores —1.48 points vs. —0.52 points on a 0—10 Numerical Rating Scale (p = 0.004; 95% CI: —1.59, —0.32). Improvements in Neuropathic Pain Scale composite score (p = 0.007), sleep NRS (p = 0.001), dynamic allodynia (p = 0.042), punctate allodynia (p = 0.021), Pain Disability Index (p = 0.003) and Patient’s Global Impression of Change (p < 0.001) were similarly greater on sat- ivex vs. placebo. Sedative and gastrointestinal side effects were reported more commonly by patients on active medication. Of all participants, 18% on sativex and 3% on placebo withdrew during the study. An open-label extension study showed that the initial pain relief was maintained without dose escalation or toxicity for 52 weeks.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Serpell, Dr Michael
• Authors: Nurmikko, T., Serpell, M., Toomey, P., Hoggart, B., Morlion, B., and Haines, D.
• Subjects: R Medicine > R Medicine (General)
• College/School: College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Clinical Specialities
• Journal Name: Pain
• Publisher: Elsevier
• ISSN: 0304-3959
• ISSN (Online): 1872-6623
• Published Online: 07 November 2007