Moxibustion at 'Danzhong' (RN17) and 'Guanyuan' (RN4) for fatigue symptom in patients with depression: Study protocol clinical trial (SPIRIT Compliant).

Background: 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.

Methods: 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.

Discussion: 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.

Trial Registration: This study protocol was registered at the Chinese Clinical Trial Registry (ChiCTR1800016905).