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Published in: Trials 1/2009

Open Access 01-12-2009 | Study protocol

The design and protocol of acupuncture for migraine prophylaxis: A multicenter randomized controlled trial

Authors: Yan Zhang, Linpeng Wang, Huilin Liu, Nan Li, Jingdao Li, Jinghong Yi

Published in: Trials | Issue 1/2009

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Abstract

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.

Discussion

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.

Trial Registration

The trial is registered at Controlled Clinical Trials: ISRCTN49839714.
Appendix
Available only for authorised users
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Metadata
Title
The design and protocol of acupuncture for migraine prophylaxis: A multicenter randomized controlled trial
Authors
Yan Zhang
Linpeng Wang
Huilin Liu
Nan Li
Jingdao Li
Jinghong Yi
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Trials / Issue 1/2009
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-10-25

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