Department of Medical Research, Korea Institute of Oriental Medicine, Acupuncture, Moxibustion & Meridian Research Group, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, South Korea.
Trials. 2013 May 21;14:147. doi: 10.1186/1745-6215-14-147.
Even though chronic fatigue syndrome and idiopathic chronic fatigue are quite common, there are no clearly known causes. Most treatments are therefore symptomatic in nature, and chronic fatigue syndrome and idiopathic chronic fatigue patients are highly interested in using oriental medicine or complementary and alternative medicine treatment. Acupuncture, one of the major treatments used in oriental medicine, is effective in treating various diseases. This study will attempt to analyze the effectiveness and safety of acupuncture in the treatment of chronic fatigue by comparing the two treatment groups (body acupuncture, Sa-am acupuncture) and the control group (usual care).
METHODS/DESIGN: This study consists of a four-center, three-arm, randomized, controlled, and open-label trial. One hundred and fifty participants are randomly divided into treatment groups A and B and a control group. The treatment groups will receive acupuncture treatments either two or three times per week for a total of 10 sessions over a period of 4 weeks. The control group will not receive acupuncture treatments and will continue their usual care during this period. The primary outcome variable is the Fatigue Severity Scale, which will be utilized 5 weeks after randomization. Secondary outcome variables are the Fatigue Severity Scale at 13 weeks, a short form of the Stress Response Inventory, the Beck Depression Inventory, the Numeric Rating Scale, and the EuroQol-5 Dimension at 5 and 13 weeks after randomization.
This study will provide evidence with high external validity on the effectiveness and safety of acupuncture as a treatment for chronic fatigue syndrome and idiopathic chronic fatigue.
Clinical Research Information Service KCT0000508.
尽管慢性疲劳综合征和特发性慢性疲劳较为常见，但目前仍不清楚其确切病因。因此，大多数治疗方法均为对症治疗，慢性疲劳综合征和特发性慢性疲劳患者非常希望采用东方医学或补充替代医学治疗。作为东方医学主要治疗方法之一的针灸，在治疗各种疾病方面具有一定疗效。本研究旨在通过对比两组治疗组（体针、Sa-am 针）和对照组（常规护理），分析针灸治疗慢性疲劳的有效性和安全性。
方法/设计：本研究为四中心、三臂、随机、对照、开放标签试验。将 150 名参与者随机分为治疗组 A 和 B 以及对照组。治疗组将每周接受 2 或 3 次针灸治疗，共 10 次，持续 4 周。对照组在此期间将不接受针灸治疗，继续接受常规护理。主要结局变量为疲劳严重程度量表，将在随机分组后 5 周进行评估。次要结局变量为疲劳严重程度量表在 13 周时的评分、应激反应量表简表、贝克抑郁量表、数字评分量表和随机分组后 5 周和 13 周的 EuroQol-5 维度。
本研究将为针灸治疗慢性疲劳综合征和特发性慢性疲劳的有效性和安全性提供具有较高外部有效性的证据。
临床研究信息服务 KCT0000508。
