Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Nov 6:14:374.
doi: 10.1186/1745-6215-14-374.

Acupuncture as prophylaxis for menstrual-related migraine: study protocol for a multicenter randomized controlled trial

Xiao-Zhe Zhang, Lei Zhang, Jia Guo, Lin Zeng, Yi Yang, Tao Zhang, Guang-Xia Shi, Hui-Lin Liu, Lin-Peng Wang  1
Affiliations
Randomized Controlled Trial

Acupuncture as prophylaxis for menstrual-related migraine: study protocol for a multicenter randomized controlled trial

Xiao-Zhe Zhang et al. Trials. .

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/design: 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.

Discussion: The results of this trial will be helpful to supply the efficacy of acupuncture for menstrual-related migraine prophylaxis.

Trial registration isrctn: ISRCTN57133712.

PubMed Disclaimer

References

    1. Stewart WF, Shechter A, Rasmussen BK. Migraine prevalence. A review of population-based studies. Neurology. 1994;Suppl 4:S17–S23. - PubMed
    1. Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American migraine study II. Headache. 2001;41:646–657. doi: 10.1046/j.1526-4610.2001.041007646.x. - DOI - PubMed
    1. Granella F, Sances G, Allais G, Nappi RE, Tirelli A, Benedetto C, Brundu B, Facchinetti F, Nappi G. Characteristics of menstrual and nonmenstrual attacks in women with menstrually related migraine referred to headache centres. Cephalalgia. 2004;24:707–716. doi: 10.1111/j.1468-2982.2004.00741.x. - DOI - PubMed
    1. Stewart WF, Lipton RB, Celentano DD, Reed ML. Prevalence of migraine headache in the United States. Relation to age, income, race, and other sociodemographic factors. JAMA. 1992;267:64–69. doi: 10.1001/jama.1992.03480010072027. - DOI - PubMed
    1. Pryse-Phillips W, Findlay H, Tugwell P, Edmeads J, Murray TJ, Nelson RF. A Canadian population survey on the clinical, epidemiologic and societal impact of migraine and tension-type headache. Can J Neurol Sci. 1992;19:333–339. - PubMed

Publication types

Associated data