←Fibromyalgia
Study register · detail Prospective Observational Study · Fibromyalgia · 2019

Safety and Efficacy of Medical Cannabis in Fibromyalgia

Sagy et al. ·Journal of Clinical Medicine Impact 3.2
Clear benefit GRADE Low 129 citations
Samplen = 367 Pat.
Duration6 months
EndpointNRS
Blindingn.a.
DesignProspective Observational Study
Cannabinoidvollspektrum
Key finding

Medical cannabis significantly reduced pain intensity in fibromyalgia and was well tolerated by the majority of patients.

Summary

Prospective observational study on medical cannabis in fibromyalgia, n=367 (82% women); 6-month follow-up. Pain intensity (NRS 0-10) reduced from median 9.0 to 5.0 (p<0.001); 81,1% (n=194) achieved treatment response. Most common side effects mild: dizziness 7,9%, dry mouth 6,7%, gastrointestinal symptoms 5,4%.

P
PopulationFibromyalgia patients, n=367, mean age 52,9 years, 82% women
I
InterventionMedical cannabis (various preparations, specialized cannabis clinic)
O
OutcomePain intensity reduced from median 9,0 to 5,0 (p<0,001); 81,1% of patients achieved treatment response after 6 months
Confidence in the evidence
Low

The second of four GRADE levels, the effect estimate is of limited reliability.

Quality profile
Sample size ★★★★★
Blinding —
Effect size Clear benefit
Citations / year ★★★★★
Authors
Sagy I, Bar-Lev Schleider L, Abu-Shakra M et al.
DOI 10.3390/jcm8060807↗
Design: Prospective Observational Study
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Indication
Further studies on Fibromyalgia
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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 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 →
A Häuser et al. · 2018 · European Journal of Pain
189 citations
European Pain Federation (EFIC) position paper on appropriate use of cannabis-based medicines and medical cannabis for chronic pain management
Unclear Leitlinie

EFIC-Positionspapier zur angemessenen Anwendung cannabisbasierter Medikamente bei chronischen Schmerzen; empfiehlt zurückhaltenden Einsatz bei Fibromyalgie aufgrund begrenzter Evidenz (schwache Empfehlung).

10.1002/ejp.1297 View study →

The impediment to action advances action. — Marcus Aurelius