title: An open-label study of effects of acupuncture on chronic fatigue syndrome and idiopathic chronic fatigue: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Research Information Service KCT0000508.
authors.affiliation: Department of Medical Research, Korea Institute of Oriental Medicine, Acupuncture, Moxibustion & Meridian Research Group, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, South Korea.
authors.forename: Jung-Eun
authors.initials: JE
authors.lastname: Kim
authors.forename: Kwon-Eui
authors.initials: KE
authors.lastname: Hong
authors.forename: Hyeong-Jun
authors.initials: HJ
authors.lastname: Kim
authors.forename: Jin-Bong
authors.initials: JB
authors.lastname: Choi
authors.forename: Yong-Hyeon
authors.initials: YH
authors.lastname: Baek
authors.forename: Byung-Kwan
authors.initials: BK
authors.lastname: Seo
authors.forename: Sanghun
authors.initials: S
authors.lastname: Lee
authors.forename: Kyung-Won
authors.initials: KW
authors.lastname: Kang
authors.forename: Min-Hee
authors.initials: MH
authors.lastname: Lee
authors.forename: Joo-Hee
authors.initials: JH
authors.lastname: Kim
authors.forename: Seunghoon
authors.initials: S
authors.lastname: Lee
authors.forename: So-Young
authors.initials: SY
authors.lastname: Jung
authors.forename: Hee-Jung
authors.initials: HJ
authors.lastname: Jung
authors.forename: Mi-Suk
authors.initials: MS
authors.lastname: Shin
authors.forename: Sun-Mi
authors.initials: SM
authors.lastname: Choi
mesh_terms: D015669:Acupuncture Points; D015670:Acupuncture Therapy / Q000009:adverse effects / Q000379:methods*; D002985:Clinical Protocols; D015673:Fatigue Syndrome, Chronic / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests; D011569:Psychiatric Status Rating Scales; D056910:Republic of Korea; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome