title: Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture.
  
  
  METHODS
  In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made.
  
  
  CONCLUSIONS
  Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).
authors.forename: Zhishun
authors.initials: Z
authors.lastname: Liu
authors.forename: Yang
authors.initials: Y
authors.lastname: Wang
authors.forename: Huanfang
authors.initials: H
authors.lastname: Xu
authors.forename: Jiani
authors.initials: J
authors.lastname: Wu
authors.forename: Liyun
authors.initials: L
authors.lastname: He
authors.forename: John Yi
authors.initials: JY
authors.lastname: Jiang
authors.forename: Shiyan
authors.initials: S
authors.lastname: Yan
authors.forename: Ruosang
authors.initials: R
authors.lastname: Du
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No,5, Beixiange Street, 100053 Beijing, Xicheng District, China. liuby@mail.cintcm.ac.cn.
authors.forename: Baoyan
authors.initials: B
authors.lastname: Liu
mesh_terms: D015669:Acupuncture Points; D015671:Electroacupuncture / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D019584:Hot Flashes / Q000628:therapy*; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D009339:Needles; D015990:Placebo Effect; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design