M Axel Wollmer, Insa Neumann, Stefanie Jung, Agnès Bechinie, Julian Herrmann, Antje Müller, Peter Wohlmuth, Larissa Fournier-Kaiser, Christian Sperling, Liza Peters, Jonas Kneer, Jannis Engel, Frank Jürgensen, Jara Schulze, Matthias Nagel, Welf Prager, Christopher Sinke, Kai G Kahl, Matthias Karst, Birger Dulz, Tillmann H C Kruger
{"title":"Clinical effects of glabellar botulinum toxin injections on borderline personality disorder: A randomized controlled trial.","authors":"M Axel Wollmer, Insa Neumann, Stefanie Jung, Agnès Bechinie, Julian Herrmann, Antje Müller, Peter Wohlmuth, Larissa Fournier-Kaiser, Christian Sperling, Liza Peters, Jonas Kneer, Jannis Engel, Frank Jürgensen, Jara Schulze, Matthias Nagel, Welf Prager, Christopher Sinke, Kai G Kahl, Matthias Karst, Birger Dulz, Tillmann H C Kruger","doi":"10.1177/02698811211069108","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Aim: </strong>This 16-week, single-blind, two-center randomized controlled trial investigated the influence of BTX on clinical symptoms of borderline personality disorder (BPD).</p><p><strong>Methods: </strong>Fifty-four patients with BPD were randomly assigned to treatment with BTX <i>(n</i> = 27) or a minimal acupuncture (ACU) control condition (<i>n</i> = 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.</p><p><strong>Results: </strong>Participants showed significant improvements at the primary efficacy endpoint in both treatment groups (BTX: <i>M</i> = -0.39, <i>SD</i> = 0.39; ACU: <i>M</i> = -0.35, <i>SD</i> = 0.42), but no superior effect of the BTX condition in comparison with the control intervention was found-<i>F</i>(1,5323) = 0.017, <i>p</i> = 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.</p><p><strong>Conclusion: </strong>Evidence regarding the efficacy of BTX for BDP remains limited, and the design of adequate control conditions presents an opportunity for further research.<i>ClinicalTrials.gov registry</i>: Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD), NCT02728778, https://clinicaltrials.gov/ct2/show/NCT02728778.</p>","PeriodicalId":156490,"journal":{"name":"Journal of Psychopharmacology (Oxford, England)","volume":" ","pages":"159-169"},"PeriodicalIF":0.0000,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"6","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Psychopharmacology (Oxford, England)","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/02698811211069108","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 6
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
