Sativex successfully treats neuropathic pain characterised by allodynia: a rando

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Pain. 2007 Dec 15;133(1-3):210-20.

Sativex successfully treats neuropathic pain characterised by

allodynia: a randomised, double-blind, placebo-controlled clinical

trial.

Nurmikko TJ, Serpell MG, Hoggart B, Toomey PJ, Morlion BJ, Haines D.

Division of Neurological Science, University of Liverpool, Liverpool,

United Kingdom.

Cannabinoids are known to have analgesic properties. We evaluated the

effect of oro-mucosal sativex, (THC: CBD), an endocannabinoid 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-titrating 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

sativex 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.