Effect of "Tiaoshen" acupuncture technique on mild depression and its underlying mechanism: A randomized controlled trial study protocol

医学 针灸科 病人健康调查表 随机对照试验 物理疗法 萧条(经济学) 生活质量(医疗保健) 汉密尔顿抑郁量表 评定量表 内科学 精神科 焦虑 抑郁症状 重性抑郁障碍 替代医学 心理学 病理 经济 护理部 扁桃形结构 宏观经济学 发展心理学
作者
Linquan Bai,Wei Zou,Long Wang,Xueping Yu,Hongjun Lou,Xiaojian Dai,Wei Teng,Weiwei Yu,Mingyue Li,Hongxin Cao,Liang Zheng
出处
期刊:Heliyon [Elsevier]
卷期号:10 (7): e28889-e28889
标识
DOI:10.1016/j.heliyon.2024.e28889
摘要

Abstract

Background

Mild depression is not just a mental disease, but also a serious and long-term public health issue. It affects the quality of life of patients and can quickly develop into major depression. There are currently no effective drug treatments with high efficacy and few adverse reactions. Acupuncture may be an alternative treatment option. Preliminary experiments and practices have demonstrated that "Tiaoshen" acupuncture improves symptoms in patients who have depression, however the underlying data and method remain unclear at present.

Methods

This is a prospective, single-center, single-blind, randomized controlled trial. We plan to recruit 70 participants and randomly assign them to receive "Tiaoshen" acupuncture or traditional acupuncture at a ratio of 1:1. Then, all the participants will receive the appropriate acupuncture treatment for four weeks. The results of the Hamilton Depression Rating Scale (HDSR-24) will serve as the primary outcome, while the results of the Patient Health Questionnaire-9 (PHQ-9) and the World Health Organization Quality of Life Measurements Short Form (WHOQOL-BREF) will serve as secondary outcomes. Evaluations will be conducted at baseline, 1, 2, and 4 weeks after treatment initiation, and 1 and 3 months after treatment completion. The safety of the intervention will be evaluated every week using the Columbia-Suicide Severity Rating Scale (C-SSRS) and the Treatment Emergent Symptoms Scale (TESS). Serum levels of oxidative stress markers 8-iso-prostaglandin FF2α (8-iso-PGF2α), superoxide dismutase (SOD), uric acid (UA), and total bilirubin (TBIL) will be measured at baseline and the end of the treatment. We will conduct a statistical analysis of intention to treat (ITT) and conformance to protocol set (PPS) data.

Discussion

This research aims to provide high-quality evidence for the efficacy and safety of "Tiaoshen" acupuncture as a treatment for mild depression. In addition, the mechanism through which acupuncture heals mild depression will be investigated.
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