A double-blind, placebo-controlled, crossover pilot trial with extension using an oral mucosal cannabinoid extract for treatment of chemotherapy-induced neuropathic pain.
Lynch et al.·Journal of Pain and Symptom ManagementImpact 0.8
MixedGRADEModerate260 citations
Samplen = 16 Pat.
ControlPlacebo spray
EndpointNRS-PI
Blindingdoppelblind
DesignRCT (crossover, Pilot)
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
”Key finding
No significant overall effect, but clinically relevant pain reduction in a subset of responders (NNT=5).
Summary
n=16 patients with chemotherapy-induced neuropathic pain, nabiximols (oral mucosal spray) vs. placebo (crossover); primary endpoint (NRS-PI group difference) not significant; responder analysis: NNT=5, mean NRS-PI reduction −2,6 points under nabiximols vs. −0,6 under placebo; 5 of 16 participants with ≥2-point reduction.
P
PopulationCancer patients with chemotherapy-induced neuropathic pain, n=16
I
InterventionNabiximols (oral mucosal spray with cannabinoids), dosage titrated
C
ControlPlacebo spray
O
OutcomeNo statistically significant difference in NRS-PI between nabiximols and placebo; responder analysis: 5 participants with ≥2-point reduction (NNT=5), mean pain reduction 2,6 vs. 0,6 under placebo (trend, not significant)
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
<h4>Context</h4>Neuropathic pain caused by chemotherapy limits dosing and duration of potentially life-saving anti-cancer treatment and impairs quality of life. Chemotherapeutic neuropathy responds poorly to conventional treatments, and there is an urgent medical need for new treatments. Recent preclinical studies demonstrate that cannabinoid agonists suppress established chemotherapy-evoked neuropathy.<h4>Objectives</h4>This was a pilot trial to begin to investigate a currently available cannabinoid agent, nabiximols (oral mucosal spray containing cannabinoids), in the treatment of chemotherapy-induced neuropathic pain.<h4>Methods</h4>A randomized, placebo-controlled crossover pilot study was done in 16 patients with established chemotherapy-induced neuropathic pain. A 0-10 point numeric rating scale for pain intensity (NRS-PI) was used as the primary outcome measure.<h4>Results</h4>When examining the whole group, there was no statistically significant difference between the treatment and the placebo groups on the NRS-PI. A responder analysis demonstrated that there were five participants who reported a two-point or greater reduction in pain that trended toward statistical significance and the number needed to treat was five.<h4>Conclusion</h4>Chemotherapy-induced neuropathic pain is particularly resistant to currently available treatments. This pilot trial found a number needed to treat of five and an average decrease of 2.6 on an 11-point NRS-PI in five "responders" (as compared with a decrease of 0.6 with placebo) and supports that it is worthwhile to study nabiximols in a full randomized, placebo-controlled trial of chemotherapy-induced neuropathic pain.