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Randomized Controlled Trial
. 2023 Mar;77(3):168-177.
doi: 10.1111/pcn.13512. Epub 2022 Dec 21.

Transcutaneous electrical cranial-auricular acupoint stimulation versus escitalopram for mild-to-moderate depression: An assessor-blinded, randomized, non-inferiority trial

Zhang-Jin Zhang  1   2 , Shui-Yan Zhang  1 , Xin-Jing Yang  1   2 , Zong-Shi Qin  1   2 , Feng-Quan Xu  3 , Gui-Xing Jin  4 , Xiao-Bing Hou  5 , Yong Liu  6 , Ji-Fu Cai  7 , Hai-Bing Xiao  7 , Yat Kwan Wong  1   2 , Yu Zheng  3 , Lei Shi  3 , Jin-Niu Zhang  4 , Yuan-Yuan Zhao  4 , Xue Xiao  5 , Liu-Lu Zhang  6 , Yue Jiao  8   9 , Yu Wang  8 , Jia-Kai He  8 , Guo-Bing Chen  10 , Pei-Jing Rong  8
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Free article
Randomized Controlled Trial

Transcutaneous electrical cranial-auricular acupoint stimulation versus escitalopram for mild-to-moderate depression: An assessor-blinded, randomized, non-inferiority trial

Zhang-Jin Zhang et al. Psychiatry Clin Neurosci. 2023 Mar.
Free article

Abstract

Aim: Transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) is a novel non-invasive therapy that stimulates acupoints innervated by the trigeminal and auricular vagus nerves. An assessor-blinded, randomized, non-inferiority trial was designed to compare the efficacy of TECAS and escitalopram in mild-to-moderate major depressive disorder.

Methods: 468 participants received two TECAS sessions per day at home (n = 233) or approximately 10-13 mg/day escitalopram (n = 235) for 8 weeks plus 4-week follow-up. The primary outcome was clinical response, defined as a baseline-to-endpoint ≥50% reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) score. Secondary outcomes included remission rate, changes in the severity of depression, anxiety, sleep and life quality.

Results: The response rate was 66.4% on TECAS and 63.2% on escitalopram with a 3.2% difference (95% confidence interval [CI], -5.9% to 12.9%) in intention-to-treat analysis, and 68.5% versus 66.2% with a 2.3% difference (95% CI, -6.9% to 11.4%) in per-protocol analysis. The lower limit of 95% CI of the differences fell within the prespecified non-inferiority margin of -10% (P ≤ 0.004 for non-inferiority). Most secondary outcomes did not differ between the two groups. TECAS-treated participants who experienced psychological trauma displayed a markedly greater response than those without traumatic experience (81.3% vs 62.1%, P = 0.013). TECAS caused much fewer adverse events than escitalopram.

Conclusions: TECAS was comparable to escitalopram in improving depression and related symptoms, with high acceptability, better safety profile, and particular efficacy in reducing trauma-associated depression. It could serve an effective portable therapy for mild-to-moderate depression.

Keywords: escitalopram; major depressive disorder; non-inferiority trial; transcutaneous electrical cranial-auricular acupoint stimulation.

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