The safety and efficacy of botulinum toxin A on the treatment of depression.

Objectives: Effective strategy for the treatment of depression is limited. This study was to evaluate the safety and efficacy of botulinum toxin A (BoNT/A) in the treatment of depression.

Methods: Seventy-six patients were assigned to the BoNT/A group (n = 52) and sertraline control group (n = 24). For the BoNT/A group, BoNT/A was injected into the frowning muscle, depressor muscle, occipital frontalis muscle, lateral canthus, and bilateral temporal region at 20 sites. Five units per site and a total of 100 units of BoNT/A were given. Patients in the sertraline control group were medicated with sertraline 50-200 mg (114.58 ± 52.08 mg) per day. Depression was assessed by the 17-item Hamilton Depression Scale (HAMD-17), 14-item Hamilton Anxiety Scale (HAMA-14), Self-rating Depression Scale (SDS), and Self-rating Anxiety Scale (SAS). All participants were followed up for 12 weeks.

Results: Scores of HAMD, HAMA, SDS, and SAS decreased significantly in both BoNT/A and sertraline groups after treatment for 12 weeks. Overall, there were no differences in decreased magnitude between the two groups (p > .05). The HAMA, SDS, and SAS results showed that the onset time of BoNT/A was earlier than that of sertraline. Side effects rates were 15.38% for BoNT/A and 33.33% for sertraline.

Conclusion: This study demonstrated significant antidepressant effects of BoNT/A. The efficacy of BoNT/A was comparable with established antidepressant sertraline. The onset time of BoNT/A was earlier than sertraline, and the proportion of side effects was less than sertraline. Therefore, BoNT/A could be a safe and effective option for the treatment of depression.