title: Acupuncture as prophylaxis for menstrual-related migraine: study protocol for a multicenter randomized controlled trial.
abstract: BACKGROUND
  Menstrual-related migraine is a common form of migraine affecting >50% of female migraineurs. Acupuncture may be a choice for menstrual-related migraine, when pharmacological prophylaxis is not suitable. However, the efficacy of acupuncture has not been confirmed. We design and perform a randomized controlled clinical trial to evaluate the efficacy of acupuncture compared with naproxen in menstrual-related migraine patients.
  
  
  METHODS
  This is a multicenter, single blind, randomized controlled clinical trial. A total of 184 participants will be randomly assigned to two different groups. Participants will receive verum acupuncture and placebo medicine in the treatment group, while participants in the control group will be treated with sham acupuncture and medicine (Naproxen Sustained Release Tablets). All treatments will be given for 3 months (menstrual cycles).The primary outcome measures are the change of migraine days inside the menstrual cycle and the proportion of responders (defined as the proportion of patients with at least a 50% reduction in the number of menstrual migraine days). The secondary outcome measures are the change of migraine days outside the menstrual cycle, duration of migraine attack, the Visual Analogue Scale (VAS), and intake of acute medication. The assessment will be made at baseline (before treatment), 3 months (menstrual cycles), and 4 months (menstrual cycles) after the first acupuncture session.
  
  
  CONCLUSIONS
  The results of this trial will be helpful to supply the efficacy of acupuncture for menstrual-related migraine prophylaxis.
  
  
  BACKGROUND
  ISRCTN57133712.
authors.forename: Xiao-Zhe
authors.initials: XZ
authors.lastname: Zhang
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.forename: Jia
authors.initials: J
authors.lastname: Guo
authors.forename: Lin
authors.initials: L
authors.lastname: Zeng
authors.forename: Yi
authors.initials: Y
authors.lastname: Yang
authors.forename: Tao
authors.initials: T
authors.lastname: Zhang
authors.forename: Guang-Xia
authors.initials: GX
authors.lastname: Shi
authors.forename: Hui-Lin
authors.initials: HL
authors.lastname: Liu
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China. wlp5558@sina.com.
authors.forename: Lin-Peng
authors.initials: LP
authors.lastname: Wang
mesh_terms: D015670:Acupuncture Therapy; D002681:China; D002985:Clinical Protocols; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008598:Menstruation; D008881:Migraine Disorders / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D009288:Naproxen / Q000627:therapeutic use; D010147:Pain Measurement; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D016861:Cyclooxygenase Inhibitors; D003692:Delayed-Action Preparations; D009288:Naproxen