←Neuropathic Pain
Study register · detail RCT (doppelblind, placebo-kontrolliert, Parallelgruppen) · Neuropathic Pain · 2014

A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment

Serpell et al. ·European Journal of Pain Impact 2.6
Mixed GRADE High 195 citations
Samplen = 246 Pat.
Duration15 weeks
ControlPlacebo spray plus existing analgesic…
EndpointNRS 30% responder rate
Blindingdoppelblind
DesignRCT (doppelblind, placebo-kontrolliert, Parallelgruppen)
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
Key finding

THC/CBD spray showed statistically significant advantages in the 30% responder rate and in sleep quality as well as SGIC, but not in the primary endpoint of mean pain reduction on the NRS scale.

Summary

n=246 peripheral neuropathic pain with allodynia, THC/CBD spray vs. placebo over 15 weeks; 30% responder rate significantly increased (p=0.034, 95% CI 1.05–3.70), sleep quality improved (p=0.0072), mean NRS reduction numerically higher but not significant.

P
PopulationAdults with peripheral neuropathic pain (PNP) associated with allodynia, n=246 randomised (128 THC/CBD, 118 placebo)
I
InterventionTHC/CBD oromucosal spray (nabiximols), in addition to existing analgesic therapy, 15 weeks
C
ControlPlacebo spray plus existing analgesic therapy
O
Outcome30% responder rate NRS significantly in favour of THC/CBD (p=0.034; 95% CI: 1.05–3.70); mean NRS reduction numerically higher under THC/CBD, however not significant; sleep quality (p=0.0072) and SGIC (p=0.023) significantly improved
Confidence in the evidence
High

The highest of four GRADE levels, the effect estimate is very reliable.

Quality profile
Sample size ★★★★★
Blinding Double-blind
Effect size Mixed
Citations / year ★★★★★
Authors
Serpell M, Ratcliffe S, Hovorka J et al.
DOI 10.1002/j.1532-2149.2013.00445.x↗
Design: RCT (doppelblind, placebo-kontrolliert, Parallelgruppen)
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Indication
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The impediment to action advances action. — Marcus Aurelius