←Neuropathic Pain
Study register · detail RCT · Neuropathic Pain · 2005

Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis

Rog et al. ·Neurology Impact 1.0
Clear benefit GRADE Moderate 677 citations
Samplen = 66 Pat.
Duration5 weeks
ControlPlacebo spray
EndpointNRS
Blindingdoppelblind
DesignRCT
Cannabinoidkombination
THC:CBD1.08:1
Max. dose129.6 mg
Routeoromukosal
Key finding

Cannabis-based medicine was superior to placebo in reducing pain intensity (p = 0,005) and sleep disturbance (p = 0,003) in MS patients with central neuropathic pain.

Summary

n=66 MS patients with central neuropathic pain; THC:CBD oromucosal spray (CBM) vs. placebo over 4 weeks. Pain reduction: CBM −2,7 points (95% CI −3,4 to −2,0) vs. placebo −1,4 (p=0,005); reduction in sleep disturbance: CBM −2,5 vs. placebo −0,8 (p=0,003). CBM well tolerated; more frequent adverse effects: dizziness, dry mouth, somnolence.

P
PopulationAdults with MS-related central pain (59 dysaesthetic, 7 painful spasms), n=66
I
InterventionCannabis-based medicine (THC:CBD, 2,7 mg THC + 2,5 mg CBD/spray), oromucosal spray, self-titrated up to max. 48 sprays/24h, 4 weeks
C
ControlPlacebo spray
O
OutcomeSignificant reduction in mean pain intensity under CBM vs. placebo (CBM -2,7 vs. placebo -1,4; p=0,005); significant reduction in sleep disturbance (CBM -2,5 vs. placebo -0,8; p=0,003)
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 Clear benefit
Citations / year ★★★★★
Authors
Rog D J, Nurmikko T J, Friede T et al.
DOI 10.1212/01.wnl.0000176753.45410.8b↗
Design: RCT
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Indication
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The impediment to action advances action. — Marcus Aurelius