The design and protocol of acupuncture for migraine prophylaxis: a multicenter randomized controlled trial.
BACKGROUND
Many studies have already reported encouraging results in the prophylactic therapy of migraine by acupuncture, but there seems to be a lack of high quality randomized controlled trials from China. We design and perform a randomized controlled clinical trial to evaluate the efficacy of acupuncture compared with flunarizine in the prophylactic therapy of patients with migraine without aura in China.


METHODS
This trial is a multicenter, prospective, randomized controlled clinical trial. The 140 migraine patients are randomly allocated to two different groups. The acupuncture groups (n = 70) is treated with acupuncture and placebo medicine; while the control group (n = 70) is treated with sham acupuncture and medicine (Flunarizine). Both Flunarizine and placebo are taken 10 mg once per night for the first 2 weeks and then 5 mg once per night for the next 2 weeks. Patients in both groups receive 12 sessions of verum/sham acupuncture in 4 weeks.


CONCLUSIONS
The study design and the long term clinical practice of acupuncturists guarantee a high external validity for the results. The results of our trial will be helpful to supply the evidence on the efficacy of acupuncture for migraine prophylaxis in China.
Zhang
Yan
Y
Beijing Traditional Chinese Medicine Hospital, Capital Medical University, Beijing, PR China. aquazhang@163.com
Wang
Linpeng
L
Liu
Huilin
H
Li
Nan
N
Li
Jingdao
J
Yi
Jinghong
J
D015670:Acupuncture Therapy; D000293:Adolescent; D000328:Adult; D000368:Aged; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D002681:China; D002985:Clinical Protocols; D005260:Female; D005444:Flunarizine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020325:Migraine with Aura / Q000517:prevention & control*; D011446:Prospective Studies; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
D002121:Calcium Channel Blockers; D005444:Flunarizine