Zhang Yuan, Liu Yamin, Ning Baile, Yan Luda, Wu Lihua, Zhang Delong, Li Changhong, Ouyang Wenwei, Su Shengyong, Jiang Shuo, Zhang Guangcai, Xu Junfeng, Wang Zhen, Zheng Zhong, Zheng Dong, Chen Shan, Sun Lu, Fu Wenbin
Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Shenzhen Bao'an Traditional Chinese Medicine Hospital, Guangzhou University of Chinese Medicine, Shenzhen, China.
Front Med (Lausanne). 2022 May 30;9:761419. doi: 10.3389/fmed.2022.761419. eCollection 2022.
Antidepressants are the front-line treatments for major depressive disorder (MDD), but remain unsatisfactory in outcome. An increasing number of patients are interested in acupuncture and moxibustion treatment as complementary therapies. This study aims to evaluate the efficacy and safety of integrative acupuncture and moxibustion (iAM) treatment in patients with MDD.
This multicenter, single-blind, 2 × 2 factorial randomized trial will enroll 592 patients with MDD of moderate severity from nine hospitals. All patients will be randomized, in a ratio of 2:2:2:1, through a computerized central randomization system, into four groups (the combined, iAM-only, sertraline-only, and placebo groups). Participants will undergo a 12-week intervention with either 50 mg of sertraline or a placebo once a day and active/sham iAM treatment three times per week. The primary outcome is depression severity, assessed using the Hamilton Depression Scale-17. The secondary outcomes include self-rated depression severity, anxiety, and sleep quality. The primary and secondary outcomes will be measured at weeks 0, 4, 8, 12, and the 8th week posttreatment. Safety will be evaluated through liver and kidney function tests conducted before and after treatment and through monitoring of daily adverse events. An intent-to-treat principle will be followed for the outcome analyses.
This trial will provide sufficient evidence to ascertain whether iAM is effective and safe for treating MDD and provides a suitable combination strategy for treating MDD.
[www.chictr.org.cn], identifier [ChiCTR2100042841].
抗抑郁药是治疗重度抑郁症（MDD）的一线疗法，但治疗效果仍不尽人意。越来越多的患者对针灸和艾灸治疗作为辅助疗法感兴趣。本研究旨在评估综合针灸和艾灸（iAM）治疗MDD患者的疗效和安全性。
这项多中心、单盲、2×2析因随机试验将从9家医院招募592例中度严重程度的MDD患者。所有患者将通过计算机化中央随机系统按2:2:2:1的比例随机分为四组（联合组、单纯iAM组、单纯舍曲林组和安慰剂组）。参与者将接受为期12周的干预，每天服用50毫克舍曲林或安慰剂一次，每周接受3次主动/假iAM治疗。主要结局是抑郁严重程度，采用汉密尔顿抑郁量表-17进行评估。次要结局包括自评抑郁严重程度、焦虑和睡眠质量。主要和次要结局将在第0、4、8、12周以及治疗后第8周进行测量。将通过治疗前后的肝肾功能检查以及每日不良事件监测来评估安全性。结局分析将遵循意向性分析原则。
本试验将提供充分证据，以确定iAM治疗MDD是否有效和安全，并为治疗MDD提供合适的联合策略。
