Qian Huan, Shao Fangjie, Lenahan Cameron, Shao Anwen, Li Yingjun
Department of Plastic Surgery, The Second Affiliated Hospital, Medical School, Zhejiang University, Hangzhou, China.
Department of Neurosurgery, The Second Affiliated Hospital, Medical School, Zhejiang University, Hangzhou, China.
Front Psychiatry. 2020 Dec 4;11:603087. doi: 10.3389/fpsyt.2020.603087. eCollection 2020.
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. 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. 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. 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.
重度抑郁症（MDD）是一种严重的精神障碍，是一个重大的公共卫生问题。已经进行了多项试验来研究A型肉毒毒素（BTX-A）在治疗MDD中的作用，但结论存在争议。为了检验BTX-A与安慰剂相比对临床诊断为MDD的患者的疗效和安全性，我们进行了这项系统评价和荟萃分析。我们在PubMed和Web of Science中对从创刊到2020年6月17日的所有相关随机对照试验（RCT）进行了系统检索。纳入了所有研究BTX-A注射对临床诊断为MDD的患者的疗效和安全性的已发表研究。使用随机效应荟萃分析模型总结总体效应大小。本荟萃分析的主要结局是BTX-A注射后第6周与安慰剂相比抑郁评定量表的变化。还评估了BTX-A注射的安全性。五项RCT共417名参与者（BTX-A组189例患者，安慰剂组228例患者）符合本荟萃分析的条件。结果表明，BTX-A注射对减轻MDD患者的抑郁症状具有总体积极作用（Hedges'g，-0.82；95%CI，-1.38至-0.27），效应大小较大。差异可能由BTX-A的剂量和参与者的性别来解释。我们的研究结果还强调，BTX-A注射通常耐受性良好，仅报告了轻微和短暂的不良事件。本荟萃分析提供了证据，表明BTX-A注射与抑郁症状的统计学显著改善相关。BTX-A注射通常是安全的，可能为抑郁症的治疗提供一种新的替代选择。
