https://orcid.org/0009-0007-5158-7568
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Abstract
Objective
Increasing number of depression cases, drug tolerability and compliance issues have triggered researchers to actively seek potential alternative treatment modalities. Integrating traditional Chinese medicine (TCM) and Western medicine (integrative medicine) has demonstrated favourable treatment outcomes for depression. However, most studies have focused on single-modality of TCM therapy, and its sustainability has rarely been evaluated. This protocol aims to describe a trial investigating the multi-modality integrative medicine effectiveness while measuring the post-intervention effect sustainability in treating liver stagnation and spleen deficiency in major depressive disorder (MDD).
Methods/design
A total of 318 eligible patients meeting the International Statistical Classification of Disease 10th Edition criteria for MDD and diagnosed with liver stagnation and spleen deficiency will be randomly allocated to receive Western medicine (Group A), Western medicine plus single-modality non-invasive TCM (Group B) or Western medicine plus comprehensive TCM (Group C). Each patient will receive a 6-week treatment; primary outcomes measured will be the overall response rate, changes in both Hamilton Depression Rating Scale 24 and Treatment Emergent Symptom Scale scores 18 weeks after randomisation. The secondary outcomes will include scores on the Pittsburgh Sleep Quality Index, Beck Depression Inventory-II, Health-related Quality of Life scale and Family Burden Scale 0, 3, 6, 10 and 18 weeks post-randomisation. Intention-to-treat analysis will be conducted using repeated-measures analysis of variance and covariance.
Discussion
Because there are various manifestations of MDD from the perspective of TCM, this trial may recommend a customised evidence-based regimen with longer potency for treating liver stagnation and spleen deficiency in MDD.
reviewing editor:
Disclosure statement
The authors report there are no competing interests to declare.
Data availability statement
No data has been collected for present protocol paper.
Additional information
Notes on contributors
Yao Song Han
Yao Song Han, is a doctoral student in the medical faculty, Universiti Teknologi MARA. He is a practicing Chinese physician in Wushan County Hospital of Traditional Chinese Medicine with vast clinical experiences. His areas of research interests include application of traditional Chinese Medicine in diseases, particularly in psychiatric illness.
Jo Anne Saw
Dr Jo Anne Saw, is a clinical psychology and senior lecturer with a strong commitment in creating mental health awareness. She excels in clinical practice, research, and teaching in the field of psychology with special interest in adolescence well-being, complementary therapies and medicine, and Cognitive Behavioural Therapy (CBT).
JiangWei Yu
JiangWei Yu, PhD, is the deputy director of the library of Guizhou University of Traditional Chinese Medicine. He is mainly engaged in the informatization and intellectualization of traditional Chinese Medicine diagnosis and the research of traditional Chinese medicine culture.
Xin Wee Chen
Dr Xin Wee Chen, DrPH, is an epidemiologist at the medical faculty, Universiti Teknologi MARA, Malaysia. She is an expert in research methodology and health education on mental health issues. Her research has been on seeking innovative approaches to promote mental health and exploring the role of traditional Chinese medicine in mental disorders.