Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China.
Department of Clinical Psychology, School of Medical Psychology, Fourth Military Medical University, 169 # West Changle Road, Xi'an, 710032, China.
Asian J Psychiatr. 2020 Jun;51:101992. doi: 10.1016/j.ajp.2020.101992. Epub 2020 Feb 27.
The aim of this study was to determine the efficacy and safety of cranial electrotherapy stimulation (CES) as an add-on treatment for TD.
A randomized, double-blind, sham-controlled trial was conducted at an outpatient, single-center academic setting. A total of 62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled. Patients were divided randomly into 2 groups and given 4 weeks' treatment, including 30 min sessions of active CES (500 μA-2 mA) or sham CES (lower than 100 μA) per day for 40 d on weekdays. Change in Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety Scale-14 items (HAMA-14) were performed at baseline, week 2, week 4. Adverse events (AEs) were also evaluated.
53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group. Both groups showed clinical improvement in tic severities compared to baseline respectively at week 4. Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
Four-week's treatment of CES for children and adolescents with TD is effective and safe, but the improvement for tic severity may be related to placebo effect.
本研究旨在确定经颅微电流刺激（CES）作为 TD 附加治疗的疗效和安全性。
在一家门诊、单中心学术机构进行了一项随机、双盲、假对照试验。共纳入 62 名年龄在 6-17 岁之间、对 4 周药物治疗缺乏临床反应的 TD 患者。患者随机分为两组，分别接受为期 4 周的治疗，包括每天 30 分钟的主动 CES（500μA-2mA）或假 CES（低于 100μA），每周 5 天。在基线、第 2 周、第 4 周时进行耶鲁综合抽动严重程度量表（YGTSS）、临床总体印象-疾病严重程度量表（CGI-S）和汉密尔顿焦虑量表-14 项（HAMA-14）的变化评估。还评估了不良事件（AE）。
53 名患者（34 名男性和 9 名女性）完成了试验，其中主动 CES 组 29 名，假 CES 组 24 名。两组在第 4 周时的 tic 严重程度均较基线有所改善。与假 CES 组的 23.96%相比，接受主动 CES 治疗的患者 YGTSS 评分降低了 31.66%，但两组间无显著差异（t=1.54，p=0.13）。
为期 4 周的 CES 治疗儿童和青少年 TD 是有效且安全的，但 tic 严重程度的改善可能与安慰剂效应有关。
