Clinical effects of glabellar botulinum toxin injections on borderline personality disorder: A randomized controlled trial

Abstract

Background: Inhibition of frowning via injections of botulinum toxin A (BTX) into the glabellar region has shown beneficial effects in the treatment of major depression. Preliminary research suggests that improvements in the affective domain are not depression-specific, but may also translate to other psychiatric disorders. Aim: This 16-week, single-blind, two-center randomized controlled trial investigated the influence of BTX on clinical symptoms of borderline personality disorder (BPD). Methods: Fifty-four patients with BPD were randomly assigned to treatment with BTX (n = 27) or a minimal acupuncture (ACU) control condition ( n = 27). Clinical outcomes were followed at 2, 4, 6, 8, 12, and 16 weeks. Primary endpoint was the relative score change on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) 8 weeks after baseline relative to the control group and adjusted for treatment center. Secondary and additional outcome variables were self-rated borderline symptoms, comorbid symptoms of depression, psychological distress, and clinical global impression. Results: Participants showed significant improvements at the primary efficacy endpoint in both treatment groups (BTX: M = −0.39, SD = 0.39; ACU: M = −0.35, SD = 0.42), but no superior effect of the BTX condition in comparison with the control intervention was found— F(1,5323) = 0.017, p = 0.68). None of the secondary or additional outcomes yielded significant group differences. Side effects were mild and included headache, transient skin or muscle irritations, and dizziness. Conclusion: Evidence regarding the efficacy of BTX for BDP remains limited, and the design of adequate control conditions presents an opportunity for further research. ClinicalTrials.gov registry: Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD), NCT02728778, https://clinicaltrials.gov/ct2/show/NCT02728778

Neuronal effects of glabellar botulinum toxin injections using a valenced inhibition task in borderline personality disorder

“…Primary and secondary clinical outcomes are described elsewhere (Ref. 43 ). The subjects were randomly allocated to a single BTX treatment of the glabellar region or a control intervention, which consisted of acupuncture treatment (ACU) of the head for about 20 min at week 0 and 2.…”

“…The groups did not show any significant differences regarding age, education years, handedness, number of comorbidities or current medication (Table 1 ). A detailed description of the sample and clinical effects can be found in Wollmer et al 43 .…”

Botulinum Toxin Injections for Psychiatric Disorders: A Systematic Review of the Clinical Trial Landscape

“…Supplementary Tables S1–S3 present the outcomes of the quality assessment for the included studies. Eleven out of seventeen studies (64.7%) were randomized [ 15 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 ], whereas the other six non-randomized studies presented five case series (29.4%) [ 16 , 34 , 35 , 36 , 37 ] and one open-label trial (5.9%) [ 38 ]. Among the case series, the condition was measured in a standard and reliable way, the outcomes were clearly reported, and four out of five (80.0%) case series had clear and appropriate statistical analyses.…”

“…Moreover, six of the published studies assessed the safety of BONT-A therapy [ 16 , 25 , 26 , 27 , 28 , 32 ]. Four of these studies [ 25 , 26 , 27 , 28 ] indicated mild adverse events associated with BONT-A.…”

Botulinum Toxin Treatment for Depression: A New Paradigm for Psychiatry

“…Notably, in addition to MDD, bipolar depression, panic disorder, post-traumatic stress disorder, borderline personality disorder, social anxiety disorder, and obsessive–compulsive disorder all demonstrate amygdala dysregulation. Preliminary studies have shown that borderline personality disorder, bipolar depression, and social anxiety disorder can be helped by glabellar BoNT injections [ 64 , 71 , 72 , 73 ]. It will, therefore, be of interest to determine a potential role for BoNT/A in psychiatric disorders in general.…”