←Neuropathic Pain
Study register · detail Neuropathic Pain · 2007

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

Nurmikko et al. ·Pain Impact 4.2
Clear benefit 428 citations
Samplen = 125
Duration5 weeks, with open-label…
ControlPlacebo oromucosal
EndpointNRS
Blindingdoppelblind
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
Key finding

Sativex led to a significantly greater reduction in pain intensity (−1,48 vs. −0,52 points, p=0,004) and improvements in allodynia, sleep and functionality compared to placebo.

Summary

RCT on oro-mucosal Sativex (THC:CBD) in peripheral neuropathic pain, n=125 (63 Sativex, 62 placebo), 5 weeks parallel design. Primary outcome: mean pain reduction (NRS 0-10) -1,48 points (Sativex) vs. -0,52 points (placebo), p=0,004 (95% CI: -1,59 to -0,32). Significant improvements also in Neuropathic Pain Scale (p=0,007), sleep NRS (p=0,001), dynamic allodynia (p=0,042), punctate allodynia (p=0,021) and Pain Disability Index (p=0,003). 18% discontinuation rate Sativex vs. 3% placebo. Open-label extension showed maintenance of pain relief over 52 weeks without dose increase.

P
PopulationAdults with peripheral neuropathic pain (with allodynia), n=125
I
InterventionSativex (THC:CBD) oromucosal, self-titrating dosage
C
ControlPlacebo oromucosal
O
OutcomePain intensity reduction (NRS 0-10): -1,48 (Sativex) vs. -0,52 (Placebo), p=0,004; 95% CI: -1,59 to -0,32
Quality profile
Sample size ★★★★★
Blinding Double-blind
Effect size Clear benefit
Citations / year ★★★★★
Authors
Nurmikko TJ, Serpell MG, Hoggart B et al
DOI 10.1016/j.pain.2007.08.028↗
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Indication
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The impediment to action advances action. — Marcus Aurelius