←Fibromyalgia
Study register · detail RCT · Fibromyalgia · 2008

Nabilone for the Treatment of Pain in Fibromyalgia

Skrabek et al. ·The Journal of Pain Impact 1.0
Clear benefit GRADE Moderate 374 citations
Samplen = 40 Pat.
Duration4 weeks treatment + 4 weeks…
ControlPlacebo
EndpointVAS
Blindingdoppelblind
DesignRCT
Cannabinoidthc
Max. dose2.0 mg
Routeoral
Key finding

Nabilone showed significant improvements in pain (VAS -2.04, P<0.02), quality of life (FIQ -12.07, P<0.02) and anxiety (-1.67, P<0.02) after 4 weeks versus placebo, with more side effects in the treatment group.

Summary

n=40 fibromyalgia patients, nabilone (synthetic THC analogue) vs. amitriptyline vs. placebo (4-week cross-over); nabilone significantly better than placebo for VAS pain (p0.02) and quality of life (FIQ p0.04), comparable to amitriptyline; most common side effect dizziness.

P
PopulationAdults with fibromyalgia, n=40
I
InterventionNabilone (synthetic cannabinoid), titrated from 0,5 mg in the evening to 1 mg BID over 4 weeks, oral
C
ControlPlacebo
O
OutcomeVAS pain reduction −2,04 (p<0,02), FIQ −12,07 (p<0,02), anxiety −1,67 (p<0,02) vs. placebo after 4 weeks; placebo group without significant improvement
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
Skrabek R Q, Galimova L, Ethans K et al.
DOI 10.1016/j.jpain.2007.09.002↗
Design: RCT
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Abstract
Perspective: To our knowledge, this is the first randomized, controlled trial to assess the benefit of nabilone, a synthetic cannabinoid, on pain reduction and quality of life improvement in patients with fibromyalgia. As nabilone improved symptoms and was well-tolerated, it may be a useful adjunct for pain management in fibromyalgia.
Indication
Further studies on Fibromyalgia
All studies →
S Rasmussen et al. · 2026 · Annals of the rheumatic diseases
1 citations
Cannabidiol versus placebo in patients with fibromyalgia: a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial.
Harm RCT

n=200 Fibromyalgie-Patienten, CBD 50 mg täglich vs. Placebo über 24 Wochen; primärer Endpunkt Schmerzintensität (NRS): CBD-Gruppe -0,4 Punkte (95% CI: -0,82 bis 0,08), Placebo-Gruppe -1,1 Punkte (95% CI: -1,53 bis -0,63), Gruppenunterschied -0,7 Punkte (95% CI: -1,2 bis -0,25; p=0,0028) zugunsten Placebo. CBD 50 mg täglich zeigte keine analgetische Wirksamkeit.

10.1016/j.ard.2025.07.008 View study →
S Moore et al. · 2025 · Rheumatology (Oxford, England)
15 citations
Effectiveness of pharmacological therapies for fibromyalgia syndrome in adults: an overview of Cochrane Reviews.
Mixed Systematic Review

Umbrella Review über k=21 Cochrane Reviews zu pharmakologischer Fibromyalgie-Therapie (87 Trials, n=17.631). Für Cannabinoide: limitierte und inadäquate Datenlage identifiziert — keine ausreichende Evidenz für Wirksamkeit. Duloxetin, Milnacipran und Pregabalin zeigten moderate/gute Evidenz für substanzielle Schmerzreduktion (≥50%) bei etwa 1 von 10 Erwachsenen über 4-12 Wochen.

10.1093/rheumatology/keae707 View study →
S Walitt et al. · 2016 · Cochrane Database of Systematic Reviews
120 citations
Cannabinoids for fibromyalgia
No benefit demonstrated Cochrane Review

Cochrane SR über 2 RCTs (n=72) zu Cannabinoiden bei Fibromyalgie; nabilone vs. Placebo zeigte keine statistisch signifikante Schmerzreduktion oder Verbesserung der Lebensqualität; sehr kleine Stichprobengröße und kurze Studiendauer limitieren Aussagekraft; keine ausreichende Evidenz für Wirksamkeit.

10.1002/14651858.cd011694.pub2 View study →

The impediment to action advances action. — Marcus Aurelius