经颅直流电刺激联合氟西汀治疗强迫症的安全性和有效性：一项随机、双盲、假刺激对照临床试验。
The safety and efficacy of transcranial direct current stimulation as add-on therapy to fluoxetine in obsessive-compulsive disorder: a randomized, double-blind, sham-controlled, clinical trial.
机构信息
Neurosciences Research Center, Qom University of Medical Sciences, Qom, Iran.
Spiritual Health Research Center, Qom University of Medical Sciences, Qom, Iran.
出版信息
BMC Psychiatry. 2020 Nov 30;20(1):570. doi: 10.1186/s12888-020-02979-1.
BACKGROUND
Obsessive-compulsive disorder (OCD) is an anxiety disorder that causes impairment in daily activities. This study aimed to assess the safety and efficacy of transcranial direct current stimulation (tDCS) as adjunctive therapy with fluoxetine in individuals diagnosed with moderate to severe OCD.
METHODS
This is a randomized, double-blind sham-controlled trial. Individuals with OCD who had baseline Yale-Brown obsessive-compulsive scale (Y-BOCS) of > 15 were enrolled. Eligible cases were randomly assigned in 1:1 ratio to receive either 20-min-period of stimulation with tDCS and fluoxetine (experimental arm) or fluoxetine only (sham control arm). The anodal electrode of tDCS was placed over the left dorsolateral prefrontal cortex (Fp3) and the cathodal electrode was placed over the right orbitofrontal cortex (F8). Two mA electrical stimulation with the tDCS was used for 20 min in individuals of experimental group. In the control group, electrodes were placed and stimulation was administered for 30 s to induce the same skin sensation as in experimental group. This procedure was performed three times per week for 8 weeks. Y-BOCS test was assessed at baseline, week 4 (after 12th stimulation), week 8 (after 24th stimulation), and 1 month after the last stimulation. The primary endpoints were the mean changes in Y-BOCS total score from baseline to the last visit. The secondary endpoints were the mean changes in obsession and compulsion sub-scores from baseline to the last visit. Adverse events were also assessed. Mixed design repeated measures analysis of variance assessed the endpoints.
RESULTS
Sixty individuals (30 in each group) were participated. All individuals in control group and 28 cases in experimental arm completed the trial. The mean Y-BOCS (F = 30.83; P < 0.001), OCD obsession (F = 25.01; P < 0.001), and compulsion (F = 10.81; P < 0.001) scores decreased significantly during the study. No statistical differences were, however, detected between experimental and control groups (P > 0.05). The tDCS was well tolerated and no major adverse events were reported.
CONCLUSION
This study showed that among individuals with moderate to severe OCD, there was no significant difference regarding OC symptoms between cases used tDCS as adjunctive therapy with fluoxetine and individuals used fluoxetine only.
TRIAL REGISTRATION
IRCT2017030632904N1 . Registered 14 July 2017, http://irct.ir/user/trial/44193/view.
背景
强迫症（OCD）是一种会导致日常活动受损的焦虑症。本研究旨在评估经颅直流电刺激（tDCS）作为氟西汀辅助治疗对中重度 OCD 患者的安全性和疗效。
方法
这是一项随机、双盲假对照试验。招募了基线耶鲁-布朗强迫量表（Y-BOCS）>15 的 OCD 患者。将符合条件的患者按 1:1 的比例随机分配，分别接受 tDCS 和氟西汀（实验组）或仅氟西汀（假对照臂）20 分钟的治疗。tDCS 的阳极电极置于左背外侧前额叶皮质（Fp3），阴极电极置于右眶额皮质（F8）。实验组的个体接受 2 毫安电刺激 20 分钟。在对照组中，电极被放置并给予 30 秒的刺激，以产生与实验组相同的皮肤感觉。每周进行三次，共 8 周。在基线、第 4 周（第 12 次刺激后）、第 8 周（第 24 次刺激后）和最后一次刺激后 1 个月评估 Y-BOCS 测试。主要终点是从基线到最后一次就诊时 Y-BOCS 总分的平均变化。次要终点是从基线到最后一次就诊时强迫观念和强迫行为子量表评分的平均变化。还评估了不良事件。混合设计重复测量方差分析评估了终点。
结果
共有 60 名患者（每组 30 名）参与了研究。对照组和实验组各有 30 名患者完成了试验。Y-BOCS（F=30.83；P<0.001）、强迫症观念（F=25.01；P<0.001）和强迫行为（F=10.81；P<0.001）评分在研究期间显著降低。然而，实验组和对照组之间没有统计学差异（P>0.05）。tDCS 耐受性良好，未报告严重不良事件。
结论
本研究表明，在中重度 OCD 患者中，与单独使用氟西汀相比，联合使用 tDCS 作为氟西汀辅助治疗的患者的 OC 症状没有显著差异。
试验注册
IRCT2017030632904N1。2017 年 7 月 14 日注册，http://irct.ir/user/trial/44193/view。
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