Abstract text (incl. figure legends and references)

Objective: To evaluate the impact of botulinum toxin (BoNT) on depression and anxiety scales in patients with migraine.

Methods: Unicentric prospective study, with data analysis of 40 patients with chronic and high frequency migraine, refractory to several oral migraine-preventive medications, from 2016 to 2022. Data concerning demographic, clinical, comorbid, and therapeutic data was obtained. Validated clinical questionnaires were applied regarding pain characteristics (Head Impact Test-6 – HIT-6, Headache Under-Response to Treatment – HURT, and Migraine Disability Assessment - MIDAS), and psychological comorbid states (STAI Form Y-1 and Form Y-2 and Zung Depression Scale). SPSS® 28 was used for statistical analysis.

Results: Eighty-seven-point five percent were female, with a mean age at the end of treatment of 46 years (σ=12.52). 30% of patients were previously diagnosed with an anxiety disorder and 37.5% had been diagnosed with depression. At 6 months of treatment, all scales showed a consistent reduction, especially HIT-6 (R²=0.932) and HURT (R²=0.956) scores. On linear regression analysis, a positive relation was found between both STAI Y-1 and STAI Y-2 and MIDAS scales (R²=0.785, R²=0.878, p2 = 0.213, R²=0.266, p<0.05), where STAI Y-2 (anxiety state) seemed to have a better correlation with pain variation. No significant statistical relation was found when analyzing the groups that had been previously diagnosed with anxiety and/or depression. No significant correlations were found when analyzing Zung Depression Scale with pain scales.

Conclusions: BoNT seems to have a positive effect on anxiety. This effect is possibly related with treatment efficacy, as measured by MIDAS and HIT-6, and it does not seem to be affected by previous diagnosis of anxiety disorders.