Kim Mikyung, Choi Eun-Ji, Kim Sung-Phil, Kim Jung-Eun, Park Hyo-Ju, Kim Ae-Ran, Seo Bok-Nam, Kwon O-Jin, Cho Jung Hyo, Chung Sun-Yong, Kim Joo-Hee
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea.
Department of Neuropsychiatry, College of Korean Medicine, Kyung Hee University, 892 Dongnam-ro, Gangdong-gu, Seoul, Republic of Korea.
Trials. 2017 Jan 13;18(1):16. doi: 10.1186/s13063-016-1741-2.
Major depressive disorder (MDD) is one of the most prevalent mental health disorders and has a significant societal economic burden. Antidepressants and cognitive behavioral therapy are two primary interventions for the standardized treatment of MDD. However, their weaknesses, such as a low response rate, a high risk of adverse events from medication, and the high cost of cognitive behavioral therapy, have resulted in a need for complementary and alternative medicine (CAM). Among the various therapeutic interventions in CAM, electroacupuncture and moxibustion have been widely used to treat various mental illnesses, including MDD. The aim of this study is to evaluate the feasibility of conducting a full-scale randomized controlled trial to investigate the efficacy and safety of electroacupuncture plus moxibustion therapy for MDD.
METHODS/DESIGN: We will include patients between the ages of 19 to 65 years with MDD. A total of 30 participants will be recruited, and they will be randomly allocated into two groups at a 1:1 ratio. Patients in the treatment and control groups will, respectively, receive real and sham electroacupuncture/moxibustion treatments, for a total of 20 sessions over 8 weeks. The primary outcome will be the Hamilton Rating Scale for Depression, and the secondary outcomes will be Beck's Depression Inventory, the Insomnia Severity Index, the State-Trait Anxiety Inventory, the EuroQol 5-Dimension Index, the Measure Yourself Medical Outcome Profile version 2, and electroencephalography. Adverse events will be monitored at each visit to assess safety. All outcomes will be assessed and analyzed by researchers blinded to the treatment allocation.
This is a two-armed, parallel-design, patient-assessor blinded, multicenter, randomized, sham-controlled pilot clinical trial. Data will be analyzed before and after treatment and during a 4-week follow-up. The results of the trial will provide a basis for further studies assessing the efficacy and safety of electroacupuncture plus moxibustion treatment for MDD.
Korean Clinical Trial Registry, CRIS-KCT0001810 . Registered on 5 February 2016 (retrospectively registered; date of enrollment of the first participant to the trial: 2 December 2015).
重度抑郁症（MDD）是最常见的精神健康障碍之一，给社会带来了巨大的经济负担。抗抑郁药和认知行为疗法是MDD标准化治疗的两种主要干预措施。然而，它们存在一些弱点，如缓解率低、药物不良事件风险高以及认知行为疗法成本高，因此需要补充和替代医学（CAM）。在CAM的各种治疗干预措施中，电针和艾灸已被广泛用于治疗包括MDD在内的各种精神疾病。本研究的目的是评估开展一项全面随机对照试验的可行性，以研究电针加艾灸疗法治疗MDD的疗效和安全性。
方法/设计：我们将纳入年龄在19至65岁之间的MDD患者。总共将招募30名参与者，并按1:1的比例随机分为两组。治疗组和对照组的患者将分别接受真电针/艾灸治疗和假电针/艾灸治疗，共8周，20次治疗。主要结局指标将是汉密尔顿抑郁量表，次要结局指标将是贝克抑郁量表、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版以及脑电图。每次就诊时监测不良事件以评估安全性。所有结局指标将由对治疗分配不知情的研究人员进行评估和分析。
这是一项双臂、平行设计、患者-评估者双盲、多中心、随机、假对照的试点临床试验。将在治疗前后以及4周随访期间对数据进行分析。该试验结果将为进一步评估电针加艾灸治疗MDD的疗效和安全性的研究提供依据。
韩国临床试验注册中心，CRIS-KCT0001810。于2016年2月5日注册（追溯注册；首例参与者入组日期：2015年12月2日）。
