←Neuropathic Pain

Study register · detail RCT (parallel, placebokontrolliert) · Neuropathic Pain · 2010

Randomized Placebo-Controlled Double-Blind Clinical Trial of Cannabis-Based Medicinal Product (Sativex) in Painful Diabetic Neuropathy

Selvarajah et al. ·Diabetes Care

No benefit demonstrated GRADE Moderate 186 citations

Samplen = 30 Pat.

ControlPlacebo

EndpointMean daily pain score

Blindingdoppelblind

DesignRCT (parallel, placebokontrolliert)

Cannabinoidkombination

THC:CBD1:1

Routeoromukosal

Key finding

Sativex showed no significantly greater pain reduction than placebo in diabetic neuropathy.

Summary

n=30 patients with painful diabetic peripheral neuropathy (DPN), Sativex vs. placebo (adjuvant, daily); improvement in pain scores in both groups, but no significant difference between groups (p>0.05). Negative finding: Sativex not more effective than placebo in DPN; depression identified as a significant confounder.

PopulationAdults with painful diabetic peripheral neuropathy (DPN), n=30

InterventionSativex (cannabis-based oral spray, THC/CBD), adjuvant, daily

ControlPlacebo

OutcomeNo significant difference in mean pain scores between groups; both groups showed significant within-group improvements

Confidence in the evidence

Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for

Imprecision

Quality profile

Sample size ★★★★★

Blinding Double-blind

Effect size No benefit

Citations / year ★★★★★

Authors

Selvarajah D, Gandhi R, Emery C J et al.

DOI 10.2337/dc09-1029↗

Design: RCT (parallel, placebokontrolliert)

Abstract

<h4>Objective</h4>To assess the efficacy of Sativex, a cannabis-based medicinal extract, as adjuvant treatment in painful diabetic peripheral neuropathy (DPN).<h4>Research design and methods</h4>In this randomized controlled trial, 30 subjects with painful DPN received daily Sativex or placebo. The primary outcome measure was change in mean daily pain scores, and secondary outcome measures included quality-of-life assessments.<h4>Results</h4>There was significant improvement in pain scores in both groups, but mean change between groups was not significant. There were no significant differences in secondary outcome measures. Patients with depression had significantly greater baseline pain scores that improved regardless of intervention.<h4>Conclusions</h4>This first-ever trial assessing the efficacy of cannabis has shown it to be no more efficacious than placebo in painful DPN. Depression was a major confounder and may have important implications for future trials on painful DPN.

The impediment to action advances action. — Marcus Aurelius