Transcranial alternating current stimulation for treating depression: a randomized controlled trial
Transcranial alternating current stimulation for treating depression: a randomized controlled trial
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经颅交流电刺激治疗抑郁症：一项随机对照试验。
DOI：
10.1093/brain/awab252
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发表时间：
2022-03-29
期刊：
影响因子：
14.5
通讯作者：
Wang, Yuping
中科院分区：
文献类型：
--
作者：
Wang, Hongxing;Wang, Kun;Wang, Yuping
用抗抑郁药治疗抑郁症是部分有效的。经颅交流电刺激可以为成年重度抑郁症患者提供一种非药物替代疗法。然而，没有研究使用刺激来治疗首次发作和药物初治的重度抑郁症患者。我们采用随机、双盲、假手术对照设计，在中国汉族人群中检查刺激治疗首次发作药物初治患者的临床疗效和安全性。从2018年6月4日至2019年12月30日，招募了100名患者，并随机分配接受20次每日40分钟，77.5 Hz，15 mA，一次前额和两次乳突主动或假刺激（每组n = 50）连续四周（第4周），并在无刺激的情况下进行额外的4周疗效/安全性评估（第8周）。主要结局为缓解率，定义为第8周时17项汉密尔顿抑郁量表（HDRS-17）评分≤ 7。次要分析为缓解率（定义为HDRS-17降低≥ 50%）、抑郁症状和严重程度从基线至第4周和第8周的变化以及不良事件发生率。在意向治疗样本中分析数据。49名活跃的和46名假的完成了研究。第8周结束时，活性治疗组50例患者中有27例（54%）和假手术组50例患者中有9例（18%）达到缓解。活性组的缓解率显著高于假手术组，风险比为1.78（95%置信区间，1.29，2.47）。与假手术组相比，活性药物组在第4周的缓解率、第4周和第8周的应答率显著更高，抑郁症状从基线至第4周和第8周的降幅更大。两组的不良事件相似。总之，对额叶皮层和两个乳突的刺激显著改善了首次发作的药物初治重度抑郁症患者的症状，可以被认为是对他们在门诊环境中的非药物干预。
Treatment of depression with antidepressants is partly effective. Transcranial alternating current stimulation can provide a non-pharmacological alternative for adult patients with major depressive disorder. However, no study has used the stimulation to treat first-episode and drug-naïve patients with major depressive disorder. We used a randomized, double-blind, sham-controlled design to examine the clinical efficacy and safety of the stimulation in treating first-episode drug-naïve patients in a Chinese Han population. From 4 June 2018 to 30 December 2019, 100 patients were recruited and randomly assigned to receive 20 daily 40-min, 77.5 Hz, 15 mA, one forehead and two mastoid sessions of active or sham stimulation (n = 50 for each group) in four consecutive weeks (Week 4), and were followed for additional 4-week efficacy/safety assessment without stimulation (Week 8). The primary outcome was a remission rate defined as the 17-item Hamilton Depression Rating Scale (HDRS-17) score ≤ 7 at Week 8. Secondary analyses were response rates (defined as a reduction of ≥ 50% in the HDRS-17), changes in depressive symptoms and severity from baseline to Week 4 and Week 8, and rates of adverse events. Data were analysed in an intention-to-treat sample. Forty-nine in the active and 46 in the sham completed the study. Twenty-seven of 50 (54%) in the active treatment group and 9 of 50 (18%) in the sham group achieved remission at the end of Week 8. The remission rate was significantly higher in the active group compared to that in the sham group with a risk ratio of 1.78 (95% confidence interval, 1.29, 2.47). Compared with the sham, the active group had a significantly higher remission rate at Week 4, response rates at Weeks 4 and 8, and a larger reduction in depressive symptoms from baseline to Weeks 4 and 8. Adverse events were similar between the groups. In conclusion, the stimulation on the frontal cortex and two mastoids significantly improved symptoms in first-episode drug-naïve patients with major depressive disorder and may be considered as a non-pharmacological intervention for them in an outpatient setting.