Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Background: Major depressive disorder (MDD) is a serious mental disorder that represents a substantial public health problem. Several trials have been undertaken to investigate the role of botulinum toxin type A (BTX-A) in the treatment of MDD, but the conclusions were controversial. To examine the...

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Main Authors: Huan Qian, Fangjie Shao, Cameron Lenahan, Anwen Shao, Yingjun Li
Format: Article
Language:English
Published: Frontiers Media S.A. 2020-12-01
Series:Frontiers in Psychiatry
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fpsyt.2020.603087/full
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author Huan Qian
Fangjie Shao
Cameron Lenahan
Anwen Shao
Yingjun Li
author_facet Huan Qian
Fangjie Shao
Cameron Lenahan
Anwen Shao
Yingjun Li
author_sort Huan Qian
collection DOAJ
description Background: Major depressive disorder (MDD) is a serious mental disorder that represents a substantial public health problem. Several trials have been undertaken to investigate the role of botulinum toxin type A (BTX-A) in the treatment of MDD, but the conclusions were controversial. To examine the efficacy and safety of BTX-A vs. placebo on patients with a clinical diagnosis of MDD, we conducted this systematic review and meta-analysis.Methods: A systematic search was conducted for all relevant randomized controlled trials (RCTs) in PubMed and Web of Science from inception to June 17, 2020. All published studies that investigated the efficacy and safety of BTX-A injections on patients with a clinical diagnosis of MDD were included. The overall effect size was summarized using a random-effects meta-analysis model. The primary outcomes of the present meta-analysis were the changes in depressive rating scale at week 6 after BTX-A injection compared with placebo. The safety of BTX-A injections also was assessed.Results: Five RCTs with a total of 417 participants (189 patients in the BTX-A group, 228 patients in placebo group) were eligible in this meta-analysis. The results indicated an overall positive effect of BTX-A injections for reducing the depressive symptoms of patients with MDD (Hedges' g, −0.82; 95% CI, −1.38 to −0.27) with large effect size. Differences are likely explained by the dose of BTX-As and the gender of the participants. Our findings also highlighted that BTX-A injections were generally well-tolerated, with only mild and temporary adverse events reported.Conclusions: The present meta-analysis provides evidence that BTX-A injections are associated with a statistically significant improvement in depressive symptoms. BTX-A injections are generally safe and may provide a new, alternative option for the treatment of depression.
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spelling doaj.art-70135b549caa47bf8cd9b906db4d914b2022-12-21T23:19:00ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402020-12-011110.3389/fpsyt.2020.603087603087Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled TrialsHuan Qian0Fangjie Shao1Cameron Lenahan2Anwen Shao3Yingjun Li4Department of Plastic Surgery, The Second Affiliated Hospital, Medical School, Zhejiang University, Hangzhou, ChinaDepartment of Neurosurgery, The Second Affiliated Hospital, Medical School, Zhejiang University, Hangzhou, ChinaBurrell College of Osteopathic Medicine, Las Cruces, NM, United StatesDepartment of Neurosurgery, The Second Affiliated Hospital, Medical School, Zhejiang University, Hangzhou, ChinaSchool of Public Health, Hangzhou Medical College, Hangzhou, ChinaBackground: Major depressive disorder (MDD) is a serious mental disorder that represents a substantial public health problem. Several trials have been undertaken to investigate the role of botulinum toxin type A (BTX-A) in the treatment of MDD, but the conclusions were controversial. To examine the efficacy and safety of BTX-A vs. placebo on patients with a clinical diagnosis of MDD, we conducted this systematic review and meta-analysis.Methods: A systematic search was conducted for all relevant randomized controlled trials (RCTs) in PubMed and Web of Science from inception to June 17, 2020. All published studies that investigated the efficacy and safety of BTX-A injections on patients with a clinical diagnosis of MDD were included. The overall effect size was summarized using a random-effects meta-analysis model. The primary outcomes of the present meta-analysis were the changes in depressive rating scale at week 6 after BTX-A injection compared with placebo. The safety of BTX-A injections also was assessed.Results: Five RCTs with a total of 417 participants (189 patients in the BTX-A group, 228 patients in placebo group) were eligible in this meta-analysis. The results indicated an overall positive effect of BTX-A injections for reducing the depressive symptoms of patients with MDD (Hedges' g, −0.82; 95% CI, −1.38 to −0.27) with large effect size. Differences are likely explained by the dose of BTX-As and the gender of the participants. Our findings also highlighted that BTX-A injections were generally well-tolerated, with only mild and temporary adverse events reported.Conclusions: The present meta-analysis provides evidence that BTX-A injections are associated with a statistically significant improvement in depressive symptoms. BTX-A injections are generally safe and may provide a new, alternative option for the treatment of depression.https://www.frontiersin.org/articles/10.3389/fpsyt.2020.603087/fullbotulinum toxin type Aantidepressantdepressionsystematic reviewmeta-analysis
spellingShingle Huan Qian
Fangjie Shao
Cameron Lenahan
Anwen Shao
Yingjun Li
Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Frontiers in Psychiatry
botulinum toxin type A
antidepressant
depression
systematic review
meta-analysis
title Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
title_full Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
title_fullStr Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
title_full_unstemmed Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
title_short Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
title_sort efficacy and safety of botulinum toxin vs placebo in depression a systematic review and meta analysis of randomized controlled trials
topic botulinum toxin type A
antidepressant
depression
systematic review
meta-analysis
url https://www.frontiersin.org/articles/10.3389/fpsyt.2020.603087/full
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