Clinical Efficacy of Integrated Acupuncture and Moxibustion Therapy Combined with Drugs in the Treatment of Acute Depressive Disorder: Protocol for a Pragmatic Randomized Controlled Trial

Qian Wu,1,* Yi Liu,2,3,* Dehui Lin,1,* Shanze Wang,1 Xuesong Liang,1 Bingxin Wu,2 Laisiqi Wan,4 Yuanyuan Liu,5 Taishun Wang,6 Huijun Liu,1 Leixin Lai,1 Lu Sun,4 Wenbin Fu1,4 1Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, Guangdong, People’s Republic of China; 2The Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People’s Republic of China; 3Department of Acupuncture and Moxibustion, Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine, Shenzhen, Guangdong, People’s Republic of China; 4Innovative Research Team of Acupuncture for Depression and Related Disorders, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, Guangdong, People’s Republic of China; 5Traditional Therapy Clinic, Guangdong Provincial Hospital of Chinese Medicine Zhuhai Hospital, Zhuhai, Guangdong, People’s Republic of China; 6School of Health Science, Guangdong Pharmaceutical University, Guangzhou, Guangdong, People’s Republic of China*These authors contributed equally to this workCorrespondence: Wenbin Fu, Email fuwenbin@139.com Lu Sun, Email sunlu197202@126.comPurpose: Escitalopram oxalate is a first-line pharmacological treatment for acute-phase depressive disorder, but delayed onset and adverse effects may compromise adherence and early treatment response. Adjunctive non-pharmacological therapies are commonly used in clinical practice. This study aims to evaluate the efficacy and safety of integrative acupuncture and moxibustion combined with escitalopram oxalate in patients with moderate depressive disorder during the acute phase.Methods: This is a single-center, open-label, pragmatic, randomized clinical trial. A total of 300 participants with moderate depressive disorder will be randomly assigned in a 1:1:1 ratio to three groups: escitalopram oxalate alone, escitalopram oxalate plus repetitive transcranial magnetic stimulation (rTMS), or escitalopram oxalate plus integrative acupuncture and moxibustion (iAM) (100 participants per group). All participants will receive escitalopram oxalate, while adjunctive rTMS will be administered five times weekly for 3 weeks and iAM three times weekly for 6 weeks.Outcome Measures: The primary outcome is the Hamilton Depression Rating Scale. Secondary outcomes include liver and kidney function, Stanford Expectations of Treatment Scale, Beck Depression Inventory-II, Generalized Anxiety Disorder-7, Hamilton Anxiety Scale, and Insomnia Severity Index.Conclusion: This trial will assess whether iAM combined with escitalopram oxalate is a feasible, safe, and potentially effective adjunctive treatment for moderate depressive disorder during the acute phase. The findings are expected to provide clinical evidence for the use of iAM in routine depression care.Trial Registration: ITMCTR2024000380 (International Traditional Medicine Clinical Trial Registry; registered on 05 Sep 2024).