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Study register · detail Phase-III RCT (doppelblind, placebo-kontrolliert) · Neuropathic Pain · 2024

Efficacy and safety of transdermal medical cannabis (THC:CBD: CBN formula) to treat painful diabetic peripheral neuropathy of the lower extremities

Seevathee et al. ·Medical Cannabis and Cannabinoids Impact 3.4
Clear benefit GRADE High 5 citations
Samplen = 100 Pat.
Duration12 weeks
ControlMatched placebo
EndpointNPSI-T
Blindingdoppelblind
DesignPhase-III RCT (doppelblind, placebo-kontrolliert)
Cannabinoidkombination
Routetopisch
Key finding

Transdermal THC:CBD:CBN reduces neuropathic pain in DPN significantly more than placebo (NPSI-T p<0,001).

Summary

n=100 diabetic peripheral neuropathy (DPN) of the lower extremities, 12-week study with transdermal cannabis formulation (THC:CBD:CBN) vs. placebo; mean NPSI-T scores decreased from 25.60 to 5.57 (intervention) vs. 25.24 to 22.85 (placebo), statistically significant at weeks 4, 8 and 12 (p<0.001). Only 10% mild side effects, comparable to placebo.

P
PopulationAdults with painful diabetic peripheral neuropathy of the lower extremities, n=100
I
InterventionTransdermal medical cannabis (THC:CBD:CBN formulation), 12 weeks topical application
C
ControlMatched placebo (transdermal)
O
OutcomeNPSI-T total score decreased from 25,60 to 5,57 (verum) vs. 25,24 to 22,85 (placebo); significant pain reduction at week 4, 8 and 12 (p<0,001)
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 Clear benefit
Citations / year ★★★★★
Authors
Seevathee K, Kessomboon P, Manimmanakorn N et al.
DOI 10.1159/000542511↗
Design: Phase-III RCT (doppelblind, placebo-kontrolliert)
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Indication
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The impediment to action advances action. — Marcus Aurelius