Efficacy of Cannabis Oil in Improving Subjective Sleep Quality in Systemic Sclerosis: A Prospective Placebo-Controlled Study.

Objective: We aimed to investigate the efficacy of cannabis oil in improving sleep quality, as evaluated using the Pittsburgh Sleep Quality Index (PSQI), in patients with systemic sclerosis (SSc) compared to placebo. Methods: An experimental investigation was conducted in patients with SSc aged 18-70 years. The treatment group received a cannabis preparation containing 2.7 mg/mL tetrahydrocannabinol (THC) and 2.5 mg/mL cannabidiol (CBD) sublingually for 4 weeks. Results: Twenty-seven participants were included in the study. One case was withdrawn due to a serious adverse event, leaving 13 participants in each group. The mean difference in PSQI scores decreased more in the treatment group than in the placebo group from baseline to post-treatment, but this difference was not statistically significant (p = 0.09). Increases in sleep duration were more frequently observed in the treatment group than in the placebo group, along with decreases in sleep disturbance, sleep medication use, and daytime dysfunction; however, these were not statistically significant. Conclusions: Cannabis oil showed some positive trends; however, our study did not provide conclusive evidence supporting the efficacy of cannabis oil in improving sleep quality. More rigorous studies are needed to confirm these findings and expand the clinical applicability of cannabinoids for sleep disorders.