Dronabinol Is a Safe Long-Term Treatment Option for Neuropathic Pain Patients

Schimrigk et al. ·European neurology Impact 1.1

No benefit demonstrated GRADE Moderate 132 citations

Samplen = 240 Pat.

Duration16-week controlled phase…

ControlPlacebo

EndpointNRS

Blindingdoppelblind

DesignRCT

Cannabinoidthc

Routeoral

Key finding

Dronabinol reduced pain intensity by 1,92 points, placebo by 1,81 points with no significant difference (p = 0,676).

Summary

Phase III RCT n=240 MS patients with central neuropathic pain, dronabinol vs. placebo (16 weeks) + 32-week open-label phase (n=100 up to 119 weeks). Primary endpoint: 11-point NRS pain reduction dronabinol −1,92 vs. placebo −1,81 (no significant difference, p=0,676). Higher adverse event rate under dronabinol vs. placebo (50,0% vs. 25,9%), long-term AE rate decreased to 26%. No drug abuse, one possible case of dependency. Safe long-term option for neuropathic MS pain.

PopulationMS patients with central neuropathic pain, n=240 (Phase III), of which n=100 in long-term follow-up

InterventionDronabinol oral, 16 weeks placebo-controlled + 32 weeks open-label (total up to 119 weeks)

ControlPlacebo (16-week phase)

OutcomePain reduction on NRS: dronabinol −1,92 vs. placebo −1,81 points, no significant difference (p=0,676)

Confidence in the evidence

Moderate

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

Downgraded for

Risk of bias

Quality profile

Sample size ★★★★★

Blinding Double-blind

Effect size No benefit

Citations / year ★★★★★

Authors

Schimrigk S, Marziniak M, Neubauer C et al

DOI 10.1159/000481089↗

Design: RCT

Abstract

Treatment of neuropathic pain (NP) symptoms associated with multiple sclerosis (MS) is frequently insufficient. Yet, cannabis is still rarely offered for treatment of pain. This clinical trial aimed at showing the positive benefit-risk ratio of dronabinol. Two hundred forty MS patients with central NP entered a 16-weeks placebo-controlled phase-III study followed by a 32-weeks open-label period. One hundred patients continued therapy for overall up to 119 weeks. Primary endpoint was change of pain intensity on the 11-point Numerical Rating Scale over a 16-weeks treatment period. Safety was assessed on the basis of adverse reactions (ARs), signs of dependency and abuse. Pain intensity during 16-weeks dronabinol and placebo treatment was reduced by 1.92 and 1.81 points without significant difference in between (p = 0.676). Although the proportion of patients with ARs was higher under dronabinol compared to placebo (50.0 vs. 25.9%), it decreased during long-term use of dronabinol (26%). No signs of drug abuse and only one possible case of dependency occurred. The trial results demonstrate that dronabinol is a safe long-term treatment option.

The impediment to action advances action. — Marcus Aurelius