Iravani Somayeh, Cai Liwei, Ha Lue, Zhou Shuzhe, Shi Chuan, Ma Yibin, Yao Qin, Xu Ke, Zhao Baixiao
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029.
Peking University Sixth Hospital, Beijing 100191.
Medicine (Baltimore). 2020 Feb;99(7):e19197. doi: 10.1097/MD.0000000000019197.
Fatigue is one of the most prevalent and debilitating symptoms of major depressive disorder (MDD). The effective management of depression-related fatigue has an important impact on the patient's abilities, functioning, and quality of life (QOL). Moxibustion has been widely used in Traditional Chinese Medicine to manage fatigue. Recent studies have also demonstrated that moxibustion is effective for treating cancer-related fatigue and chronic fatigue syndrome. However, there is not sufficient data supporting the effect of moxibustion for depression-related fatigue. Therefore, this randomized, assessor-blinded, wait-list controlled trial is designed to evaluate the effectiveness, safety, and feasibility of moxibustion treatment for depression-related fatigue.
One hundred and seventy-six participants who meet the diagnostic criteria for depression in the International Classification of Diseases, tenth revision (ICD-10), and who also have a score of ≥1 on the 13 item of the Hamilton Depression Rating Scale-17 (HAMD-17), will be enrolled. At study entry, participants will undergo anti-depressant treatment for at least 1 month. Then those who still have a score of ≥1 on the 13 item of the HAMD-17 will be randomly allocated to either a moxibustion group or wait-list control group in a ratio of 1:1. Anti-depressants will be provided for both groups during the whole process of the study period. Participants in the moxibustion group will undergo 14 sessions of moxibustion (over 2 weeks) with anti-depressant treatment, and participants in the wait-list control group will receive only anti-depressant treatment. Subsequently, participants in the moxibustion group will be followed-up for 4 weeks. The primary outcome measure will be the Fatigue Severity Scale (FSS). The secondary outcome measure will be the HAMD-17. Safety will be assessed by monitoring adverse events during the study. Trial feasibility will also be assessed in this study.
The results of this study may provide evidence for the efficacy of moxibustion as an adjunct to antidepressants for depression-related fatigue, and promote a more widespread foundation for the selection of moxibustion in the clinical setting as well as for future research in moxibustion therapy.
This study protocol was registered at the Chinese Clinical Trial Registry (ChiCTR1800016905).
疲劳是重度抑郁症（MDD）最常见且使人衰弱的症状之一。有效管理与抑郁症相关的疲劳对患者的能力、功能及生活质量（QOL）具有重要影响。艾灸在传统中医中已被广泛用于管理疲劳。近期研究也表明，艾灸对治疗癌症相关疲劳和慢性疲劳综合征有效。然而，尚无足够数据支持艾灸对与抑郁症相关疲劳的疗效。因此，本随机、评估者盲法、等待列表对照试验旨在评估艾灸治疗与抑郁症相关疲劳的有效性、安全性和可行性。
将招募176名符合《国际疾病分类》第十版（ICD - 10）抑郁症诊断标准且汉密尔顿抑郁量表17项版本（HAMD - 17）中第13项得分≥1分的参与者。在研究开始时，参与者将接受至少1个月的抗抑郁治疗。然后，那些在HAMD - 17第13项中得分仍≥1分的参与者将按1:1的比例随机分配至艾灸组或等待列表对照组。在研究期间的整个过程中，两组都将提供抗抑郁药物。艾灸组的参与者将在接受抗抑郁治疗的同时进行14次艾灸（为期2周），等待列表对照组的参与者将仅接受抗抑郁治疗。随后，艾灸组的参与者将接受4周的随访。主要结局指标将是疲劳严重程度量表（FSS）。次要结局指标将是HAMD - 17。将通过监测研究期间的不良事件来评估安全性。本研究还将评估试验的可行性。
本研究结果可能为艾灸作为抗抑郁药物辅助治疗与抑郁症相关疲劳的疗效提供证据，并为在临床环境中选择艾灸以及未来艾灸疗法的研究奠定更广泛的基础。
本研究方案已在中国临床试验注册中心注册（ChiCTR1800016905）。
