Kim Mikyung, Choi Eun-Ji, Kwon O-Jin, Park Hyo-Ju, Kim Ae-Ran, Seo Bok-Nam, Chung Sun-Yong, Lee Jun-Hwan, Kim Joo-Hee
Department of Internal Medicine, College of Korean Medicine, Sangji University, Wonju, Republic of Korea.
Haneum Neuropsychiatry Clinic of Korean Medicine, Cheonan, Republic of Korea.
Integr Med Res. 2022 Jun;11(2):100802. doi: 10.1016/j.imr.2021.100802. Epub 2021 Nov 3.
The first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD.
Thirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment.
The primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067).
A clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD.
The protocol was registered at Korean Clinical Trial Registry (CRIS-KCT0001810).
重度抑郁症（MDD）的首选治疗方法是使用抗抑郁药，然而，由于其低依从性和缓解率，对替代疗法有大量需求。本研究旨在探讨电针加艾灸疗法治疗MDD的有效性、安全性和可行性。
30名成年MDD患者被随机分为治疗组（TG）或对照组（CG）。TG接受电针加艾灸治疗，CG在非穴位接受假干预，为期8周。主要结局指标是基线至第9周期间，两组汉密尔顿抑郁量表（HRSD）总分平均变化的组间差异。次要结局指标包括贝克抑郁量表、失眠严重程度指数、状态-特质焦虑量表、欧洲五维健康量表、自测健康状况简表第2版，以及通过脑电图测量的额叶α波不对称性。监测不良事件（AE）进行安全性评估。
两组主要结局指标无显著差异（p = 0.2641），尽管两组治疗后HRSD评分均显著改善。两组次要结局指标无显著差异。两组AE发生率无显著差异（p = 0.1067）。
一项使用电针加艾灸治疗MDD的临床试验似乎可行。然而，需要进一步开展更大规模的研究，并采用理想的对照，以对电针加艾灸治疗MDD的疗效和安全性得出确定性结论。
该方案已在韩国临床试验注册中心注册（CRIS-KCT0001810）。
