Feasibility, Safety and Preliminary Efficacy of 1:1 THC:CBD Cannabis Oil for Fibromyalgia Symptoms: Results From a Randomised, Double-Blind, Placebo-Controlled Pilot Trial.
Kurlyandchik et al.·Pain research & managementImpact 1.6
MixedGRADEModerate0 citations
Samplen = 24 Pat.
Duration4-week dose titration followed…
ControlPlacebo oil
EndpointFeasibility and…
Blindingdoppelblind
DesignRCT
Cannabinoidkombination
THC:CBD1:1
Routeoral
”Key finding
Medium to large effects for pain reduction, sleep quality and fibromyalgia impact in favor of cannabis; no significant effect on fatigue and anxiety/depression.
Summary
n=24 fibromyalgia patients, pilot RCT over 16 weeks; 1:1 THC:CBD cannabis oil (10 mg/mL each) vs. placebo. Retention 91,7% (22/24), adherence ≥90%. Clinically meaningful FIQR improvement (≥45,5% MCID) in 40% of the cannabis group vs. 10% placebo. Pain reduction ≥30%: 70% cannabis group post-titration and week 12 vs. 20%/40% placebo. Medium to large effects for pain reduction, sleep quality, FIQR reduction (between-group comparison). Fatigue and anxiety/depression unchanged. No serious adverse events. Small sample size, caution warranted in interpretation.
OutcomeMedium to large effect sizes in favor of cannabis for pain reduction, sleep quality and FIQR; FIQR-MCID achieved in 40% (cannabis) vs. 10% (placebo); ≥30% pain reduction in 70% (cannabis) vs. 20–40% (placebo); no significant changes in fatigue and anxiety/depression
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size★★★★★
BlindingDouble-blind
Effect sizeMixed
Citations / year★★★★★
Authors
Kurlyandchik I, Tiralongo E, Lauche R, Tracey G, Ng J, Schloss J
Fibromyalgia is a chronic disorder characterised by widespread pain and other symptoms that substantially impact the quality of life. This double-blind, randomised, placebo-controlled trial primarily assessed feasibility (procedures and intervention adherence) and safety/tolerability of a 1:1 delta-9-tetrahydrocannabinol:cannabidiol (THC:CBD) cannabis oil (10 mg/mL each) in 24 adults with fibromyalgia, with secondary, preliminary assessment of efficacy across symptom domains. Participants completed a 4-week dose titration followed by 12 weeks of stable dosing. Of 77 prescreened individuals, 24 were randomised, yielding a screening-to-enrolment ratio of approximately 3:1 (31.2%). Recruitment reached 66.7% of the target (24/36); the shortfall was mainly due to geographic and legal barriers. Retention was 91.7% (22/24) and adherence was high, with all participants taking >/= 90% of the prescribed doses. The study medication was well tolerated in this small sample, with adverse events mostly mild and no serious events observed. Secondary outcomes suggested medium to large between-group effects favouring cannabis for pain reduction, improved sleep quality, and reduced fibromyalgia impact (FIQR), but findings should be interpreted cautiously given the small sample. Clinically meaningful FIQR improvement (predefined MCID 45.5%) occurred in 40% of the cannabis-treated participants versus 10% with placebo. For pain, 70% of the cannabis group reported >/= 30% reduction post-titration and at Week 12 (Placebo 20% and 40%, respectively). Fatigue and anxiety/depression showed no significant changes. A randomised trial of 1:1 THC:CBD oil appears feasible with excellent retention and adherence, though recruitment barriers need addressing. Preliminary safety and efficacy signals warrant confirmation in larger, adequately powered trials. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12623000345684.