Background: Repetitive transcranial magnetic stimulation (rTMS) is a new type of physiotherapy technology that has been widely used in the research of depression. Although many clinical trials have found that compared to the placebo interventions, rTMS has a significant effect on the improvement of depressive symptoms, the outcomes remain inconsistent due to differences in rTMS treatment frequency, parameter settings, and site for stimulation.
Aims: This study systematically evaluated the safety and efficacy of rTMS combined with antidepressants for the treatment of depression in Chinese and English randomized, double-blind and sham controlled trials and explored the possible related factors affecting the efficacy and safety.
Methods: We used keywords "depression" and "transcranial magnetic Stimulaton" as filters to search for the Clinical Randomized Controlled Trials (RCTs) of rTMS treatments for depression both in Chinese electronic databases: Wan fang, Wellpresi, and China Knowledge Network and in English electronic databases: PubMed, Web of Science, Embase, PsycINFO, Cochrane Library (total 8 databases) up to January 5, 2017; assessed the quality of the included studies with Cochrane risk of bias assessment tool; and according to the trial groups performed statistical analysis of the efficacy and safety presented in the included studies with RevMan5.3 software.
Results: A total of 9798 articles were retrieved, and finally, 29 studies were included in this study, with a total sample size of 1659, in which the sample size of the study groups was 838, and the control group sample size was 821. After Meta-analysis, we found that treatment combined rTMS with antidepressants improves depressive symptoms in patients with depression (SDM=-0.84, 95%CI=-1.19 ~ -0.48). Based on the Cochrane risk bias Assessment tool, an assessment of the bias of the included studies was conducted, one of which was assessed as having a "high risk of bias" and others as "impossible to judge". None of the included studies reported significant adverse events, and Meta-analysis showed no statistically significant differences in dropout rate between the two groups (RR=1.27, 95%CI: 0.75~2.12, Z=0.89, p=0.37).
Conclusion: treatment that combined rTMS with antidepressant medication for depressive symptoms has a certain therapeutic advantage versus the placebo controls, demonstrated slight side effects, and attained good acceptability, but the differences between trials remained relatively large. Clinical trials with large sample sizes are required for further exploration of the possible related factors affecting the efficacy.
背景: 重复经颅磁刺激（repetitive transcranial magnetic stimulation, rTMS）是一种新型的物理治疗技术，已经被广泛用于抑郁症的研究。尽管大量的临床实验发现相对于伪刺激，rTMS 对抑郁症状有改善作用，但是由于rTMS 治疗的频率、参数、部位等不同，因此研究结论仍不一致。.
目的: 本研究系统评价中英文研究中rTMS 联合抗抑郁药物在随机、双盲、伪刺激对照试验中对郁抑症状治疗的安全性及有效性，探索其中与疗效和安全性的可能相关因素。.
方法: 利用关键词“ 抑郁”“ 经颅磁刺激” 查询中文数据库：万方、维普、中国知网，英文电子数据库： Pubmed、Web of Science、Embase、PsycInfo、Cochrane Library 共8 个数据库截止到2017 年1 月5 日收录的 rTMS 治疗抑郁症的临床随机对照研究（randomized controlled trials，RCTs），利用Cochrane 风险偏倚评估工具评估纳入研究的文献质量，利用RevMan5.3 软件，根据研究组别对纳入的研究治疗效果及安全性进行统计分析。.
结果: 共检索到9798 篇文献，最终29 篇文献纳入本研究，总样本量1659 例，其中研究组样本838 例，对照组样本821 例，进行Meta 分析后发现rTMS 联合抗抑郁药物可改善抑郁症患者的抑郁症状（SMD=-0.84, 95%CI=-1.19 ～ -0.48）。纳入的研究中均无重大不良事件报道，Meta 分析两组间脱落率差异无统计学意义（RR=1.27，95%CI: 0.75 ～ 2.12，Z=0.89，p=0.37）。GRADE 对主要结局指标的证据质量评价为中等水平。.
结论: 抗抑郁药物联合rTMS 治疗抑郁症状相对于伪刺激有一定的治疗优势，副反应轻微，可接受性好，研究间差异较大，有待大样本临床研究探索影响疗效的相关因素。.
Keywords: depression; meta-analysis; repetitive transcranial magnetic stimulation.