Efficacy of cannabis oil on appetite and quality of life in systemic sclerosis patients: a randomized placebo-controlled trial.

BACKGROUND: The efficacy of cannabinoids as appetite stimulants in chronic wasting disorders is well established; however, their role in systemic sclerosis (SSc) remains to be elucidated. We aimed to evaluate the efficacy of cannabis oil on appetite, inflammatory markers, quality of life (QoL), and adverse events in patients with SSc compared to placebo. METHODS: A randomized placebo-controlled trial was conducted in 27 SSc patients with anorexia or malnutrition, according to sample size analysis. Patients with overlap connective tissue diseases, malignancies, or severe medical conditions were excluded. Participants were randomized 1:1 to receive either cannabis oil or placebo (two drops sublingual twice daily). The endpoints included changes in appetite grading using the visual analogue scale (VAS), body weight (BW), daily calorie intake, inflammatory markers, and QoL assessed using the EuroQol-5 Dimension (EQ-5D). RESULTS: Thirteen patients in each group completed the study (66.7% were female, and 77.9% had diffuse cutaneous SSc). The cannabinoid group trended toward greater improvements in appetite, satisfaction with eating, ability to eat more, BW, daily calorie intake, health VAS, and reduced inflammatory markers than the placebo group, although the differences were not statistically significant. Transferrin, transforming growth factor-β, and serum albumin levels did not differ between the groups. The VAS score for hunger significantly increased in the treatment group (p < 0.001) but not in the placebo group. One patient in the treatment group developed severe hyponatremia and was withdrawn from the study. CONCLUSION: Cannabis oil showed a trend toward improving appetite, BW, calorie intake, and QoL in SSc patients with anorexia, though most results were not statistically significant. Hunger VAS scores increased significantly, and inflammatory markers showed some reduction. Larger studies are needed to confirm these findings. CLINICAL TRIAL NUMBER: NCT05416697, registered on June 9, 2022.