A new study published in the Journal of Neurology found that a treatment containing 2.7 mg of THC and 2.5 mg of CBD was associated with significant reductions in restless legs syndrome severity, with improvements maintained for up to one year among patients who remained on the therapy.
The study was conducted by researchers from Universidad Europea de Madrid and Hospital Universitario de Getafe.
Restless legs syndrome, or RLS, is a neurological condition that causes uncomfortable sensations in the legs and an urge to move them, often worsening at night and disrupting sleep. Dopamine agonists were once considered a first-line treatment, but newer recommendations have shifted toward α2δ ligands to help prevent augmentation, a condition in which symptoms worsen over time with treatment.
Researchers noted that cannabinoids may represent a potential therapeutic option because they can inhibit glutamate release in the striatum, a brain region involved in movement regulation.
For the exploratory prospective study, 18 patients with RLS were enrolled, including 16 with multiple sclerosis. Participants underwent blood testing, respiratory polygraphy and 14 days of actigraphy before treatment began. Researchers assessed RLS severity, sleepiness, disability, muscle tone and quality of life at baseline, one month and three months, with actigraphy repeated at three months.
At baseline, participants had severe RLS, with an average International Restless Legs Syndrome Rating Scale score of 22.44. After one month and three months of treatment with the THC-CBD formulation, IRLS scores improved significantly.
Researchers also found that wake after sleep onset, a measure of time spent awake after initially falling asleep, was significantly reduced. However, sleep latency and sleep efficiency did not significantly change.
After one year, 66.66% of participants remained on the treatment and continued to show sustained improvement in RLS severity.
The authors concluded that the 2.7 mg THC/2.5 mg CBD treatment was effective in reducing RLS severity in this small open-label study, including among patients with multiple sclerosis-associated and idiopathic RLS.
The study’s findings are limited by its small sample size, lack of placebo control and open-label design, meaning participants and researchers knew the treatment being used. Researchers said additional controlled studies are needed to better evaluate the therapy’s effectiveness and safety.
