Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data
Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data
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DOI：
10.1016/j.jad.2017.06.021
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发表时间：
2017-10-15
影响因子：
6.6
通讯作者：
Loo, Colleen K.
中科院分区：
文献类型：
--
作者：
Moffa, Adriano H.;Brunoni, Andre R.;Loo, Colleen K.
背景：经颅直流电刺激是一种非侵入性脑刺激方式，已越来越多地用于治疗抑郁症。虽然在健康志愿者中的研究表明该技术具有良好的耐受性，但在MDD患者中，tDCS的安全性和可接受性尚未得到充分的探索。方法：我们收集了6项随机临床试验的个体患者数据，这些试验之前已通过系统回顾和荟萃分析确定。主要结果是安全性(不良事件发生率)和可接受性(辍学率)。结果：活动组(8.8%)和非活动组(12%)的脱落率无显著差异(OR=0.7，p=0.38)。活动组(73.5%)和假活动组(68.3%)的不良事件发生率无显著差异(OR=1.4，p=0.23)。较高的电流密度与较低的不良事件发生率相关。限制：没有系统地报告辍学原因，也没有使用标准化的研究问卷收集不良事件。结论：在MDD的随机临床试验中，积极的tDC与假的tDC一样可以接受和安全。
Background: Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder (MDD) treatment. Although studies in healthy volunteers showed that the technique is well-tolerated, tDCS safety and acceptability have not been sufficiently explored in patients with MDD.Methods: We collected individual patient data from 6 randomized clinical trials that had been previously identified in a systematic review and meta-analysis. Primary outcomes were safety (rate of adverse events) and acceptability (rate of dropouts). Secondary outcomes were clinical, demographic and treatment predictors of the primary outcomes.Results: Dropout rates between active (8.8%) and sham (12%) groups were not significantly different (OR= 0.7, p=0.38). Adverse event rates between active (73.5%) and sham (68.3%) groups were not significantly different (OR= 1.4, p=0.23). Higher current densities were associated with lower adverse event rates.Limitations: Dropout reasons were not systematically reported and adverse events were not collected using questionnaires standardized across studies.Conclusions: Active tDCS is as acceptable and safe as sham tDCS, as found in randomized clinical trials of MDD.