School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, Shanghai, China.
Ann Palliat Med. 2020 Sep;9(5):3571-3583. doi: 10.21037/apm-19-461. Epub 2020 Aug 4.
Chronic fatigue syndrome (CFS) is characterized by persistent fatigue, which often leads to physical and psychological damage. Cognitive behavioral therapy (CBT) is considered to be one of the most effective treatments. Prolong life with nine turn method (PLWNT) Qigong is a combination of complex two-way traffic path connecting the cognitive center and the enteric nerves. In this study protocol, we will explore the effectiveness of PLWNT for physical and mental fatigue, gastrointestinal function, depression, and sleep quality in patients with CFS using clinical effectiveness scales and functional magnetic imaging (fMRI).
A randomized controlled trial (RCT) consisting of 90 patients will be divided into a CBT and PLWNT group. Both of the groups will include a supervised intervention at the Shanghai University of Traditional Chinese Medicine once a week, and the remaining six days will be completed at home over 12 consecutive weeks. The primary outcome variable will be the Multidimensional Fatigue Inventory (MFI20). Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
This will be the first randomized controlled clinical trial to introduce the PLWNT method for the treatment of CFS. If these results demonstrate that CBT or PLWNT interventions are effective, they will provide a quality treatment plan for patients with chronic fatigue and optimize their guidance.
Clinical Trials Registry, NCT03496961, Registered on April 12, 2018.
慢性疲劳综合征（CFS）的特征是持续疲劳，这往往会导致身体和心理损伤。认知行为疗法（CBT）被认为是最有效的治疗方法之一。“九转回春功”（PLWNT）是一种将认知中心与肠神经系统连接起来的复杂双向交通路径的气功结合。在本研究方案中，我们将使用临床疗效量表和功能磁共振成像（fMRI）来探索 PLWNT 对 CFS 患者身心疲劳、胃肠功能、抑郁和睡眠质量的有效性。
一项由 90 名患者组成的随机对照试验（RCT）将分为 CBT 和 PLWNT 组。两组都将在上海中医药大学接受每周一次的监督干预，其余六天将在 12 周的连续时间内在家中完成。主要结局变量将是多维疲劳量表（MFI20）。次要结局将评估 36 项简短健康调查（SF-36）、匹兹堡睡眠质量指数（PSQI）、医院焦虑和抑郁量表（HADS），并使用 fMRI 探索大脑激活情况。
这将是第一个引入 PLWNT 方法治疗 CFS 的随机对照临床试验。如果这些结果表明 CBT 或 PLWNT 干预是有效的，它们将为慢性疲劳患者提供优质的治疗方案，并优化他们的指导。
临床试验注册，NCT03496961，于 2018 年 4 月 12 日注册。
