Several drug options and different formulations are available to treat migraine acutely.
Non-specific treatments, such as aspirin, acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and combination analgesics, are used to treat migraine and a wide range of pain disorders 10.
Migraine is a highly prevalent disorder which manifests clinically as moderate to severe or severe headache attacks with frequent frontotemporal unilateral location and associated symptoms 123.
Although these evidences clearly suggest advantages with the combination of drugs acting on different mechanisms involved in migraine, there is still a lack of controlled studies to support it.
Migraine is a neurological disorder characterized by recurrent attacks of severe headache, affecting around 12% of Caucasian populations.
Migraine is a common neurological disorder with variable expression, affecting more than 12% of the general population 1.
It is well known that migraine has a strong genetic component, although the number and type of genes involved is still unclear.
The International Headache Society (IHS) has formally classified migraine into two main subtypes: migraine with aura (MA) and migraine without aura (MO) 2.
In this article, we report the design and the protocol of a randomized controlled large-scale trial to treat migraine using acupuncture, aiming at testifying it is effective to use acupuncture to treat migraine.
It involves in comparing the efficacy of acupoints treatment with non-acupoints treatment and the efficacy of different acupoints treatment, after efficacy of acupuncture treating migraine is convinced from the first part of our project.
We believe this trial could demonstrate that the efficacy of using acupuncture to treat migraine is not due to physiological effects of acupoints suspected in 7, but the real 'specific effects' of acupoints based on meridians and a collection of meridian Qi.
The secondary Outcome Measures are the differences in frequency of migraine attacks (episodes of migraine headaches separated by pain free intervals of at least 48 hours), average duration of a migraine attack, rate of rescue medication used, number of patients with adverse side effects, Migraine-Specific Quality-of-Life Questionnaire (MSQ) before randomization and 4, 8, and 16 weeks after randomization, and the differences in Transcranial Doppler Sonography (TCD) before randomization and 4 weeks after randomization.
It is not specific for CH, since it is also very prominent, and much better demonstrated, in migraine.
Migraine and CH are both very incapacitating and share common features, but they also differ on specific points.
Both CH and migraine can be triggered by alcohol, and relieved by triptans, but CH necessitates parenteral routes of administration.
Migraine is much more frequent than CH (15% of the general population versus 0.05%–0.1%), affects mainly women, and starts earlier in life, often during adolescence or around menarche.
Migraine is a common condition associated with significant disability 2.
Children are included because migraine is a significant problem in children, with limitations in pharmacologic approaches 19.
Although migraine is a common disorder, many sufferers either do not seek medical attention or, when they do, are not treated for migraine 2122.
The rationale for headache frequency criteria is that patients with more than 5 headaches per month could be considered to have failed conventional therapy, especially if function is significantly impaired, while those with more than 15 headaches per month are considered to have chronic migraine and may be physiologically different than those with episodic migraine 18.
It was reported that migraine was more closely correlated to daily hassles than stressful events 10.
It is questionable how stress and mood changes are related to migraine: Are stress and mood changes related to migraine independently or interactively?
To clarify whether or not the results of the study are applicable only to migraine, it is necessary to compare migraine and chronic headache, for which a relation to stress is indicated, such as tension-type headache.
However, preventive treatments have been applied to migraine with frequent attacks.
According to the theory of traditional Chinese medicine, migraine headaches can be considered as syndromes of meridians 24.
The main inclusion criteria are: patients suffering from migraine without aura (more than 2 migraine attacks in 4 weeks), diagnosed according to diagnostic criteria of the International Headache Society 1; male or female; aged 18–65 years; patients who had not used acupuncture or drugs with migraine prophylactic effects within the last 3 months; patients who have given written informed consent.
Migraine prevalence are roughly 12% of the adults in western countries 2 and 4.2%–14.6% in China 3.
The diagnosis of migraine is based on criteria developed by the International Headache Society in 1988 and revised in 2004 – the International Classification of Headache Disorders II (ICHD II) 1.
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