title: Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial.
abstract: BACKGROUND
  More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que) and KID-6 (Zhao Hai), which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu) with BL-23 (Shen Shu) and BL-19 (Dan Shu) with N-HN-54 (An Mian). The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment.
  
  
  METHODS
  In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQI)and the Hamilton rating scale(HAMD) for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months.
  
  
  CONCLUSIONS
  A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia.
  
  
  BACKGROUND
  The trial was registered in Chinese Clinical Trial Register (ChiCR-TRC-00000481) on 12 August 2009.
authors.affiliation: Guangzhou University of Traditional Chinese Medicine (TCM), Guangzhou, China.
authors.forename: Yuan-Fang
authors.initials: YF
authors.lastname: Chen
authors.forename: Jian-Hua
authors.initials: JH
authors.lastname: Liu
authors.forename: Neng-Gui
authors.initials: NG
authors.lastname: Xu
authors.forename: Zhao-Hui
authors.initials: ZH
authors.lastname: Liang
authors.forename: Zhen-Hua
authors.initials: ZH
authors.lastname: Xu
authors.forename: Shu-Jun
authors.initials: SJ
authors.lastname: Xu
authors.forename: Wen-Bin
authors.initials: WB
authors.lastname: Fu
mesh_terms: D000293:Adolescent; D000328:Adult; D006801:Humans; D008875:Middle Aged; D015670:Acupuncture Therapy / Q000009:adverse effects; D003627:Data Interpretation, Statistical; D003863:Depression / Q000628:therapy; D004311:Double-Blind Method; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D007319:Sleep Initiation and Maintenance Disorders / Q000628:therapy; D016032:Randomized Controlled Trials as Topic; D015337:Multicenter Studies as Topic