Acupuncture in Chronic Migraine: A Randomized Controlled Trial

Study Overview
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Brief Summary
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The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment compared with pharmacologic treatment in patients with chronic migraines.Besides, the investigators tested whether the clinical effects of acupuncture in chronic migraine prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).

Detailed Description
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Subjects who completed the prospective baseline periods and meet met the prespecified entry criteria will be randomized into 2 groups: acupuncture treatment, and topiramate treatment group. Subjects will be allowed to continue taking acute migraine medications for the treatment of breakthrough attacks during the trial, but any migraine preventive medications will be prohibited. Written informed consent was obtained from all participants before entering the study.

Official Title
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Acupuncture in Chronic Migraine: A Randomized Controlled Trial

Conditions
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Patients With Chronic Migraine

Intervention / Treatment
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* Procedure: acupuncture
* Drug: topiramate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years old Patients were required to have a diagnosis of chronic migraine with or without medication overuse that satisfied the ICHD-2 criteria during the last 3 months prior to trial entry, with an established migraine history for at least 1 year. Exclusion Criteria: Patients did not fulfill the criteria of ≧ 15 days or response to triptans or ergots on at least 8 days in prospective baseline periods . The presence of headaches other than chronic migraine (such as another primary chronic headache or any secondary headache). Migraine prophylaxis agents during last 3 months including β-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents or cycle-modulating hormonal drugs. Migraine onset after age 50 or the age at onset of CM > 60 years. History of hepatic disorder, nephrolithiasis or other severe illness. Cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms. Prior fearful experience of acupuncture. Bleeding diathesis or anticoagulation. Pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br> | Procedure: acupuncture<br>* Each patient had a fixed and classic acupuncture points Ex-HN-3,BL-2,GB-20,EX-HN-5 bilaterally in their 24 sessions. Acupuncture consisted of 24 sessions of 30 min duration, administrated over 12 weeks (two sessions per week). Sterile disposable and steel needle (3210) were used . The needles were manipulated by rotation methods to produce a characteristic sensation know as De Qi.<br>|
| Active Comparator: topiramate<br> | Drug: topiramate<br>* The patients were submitted to the topiramate treatment also for 12 consecutive weeks. The study phase consists of a 4-week titration and a 8-week maintenance period. All dosages of topiramate will be initiated at 25 mg/d hs and increased by 25 mg/d weekly to a maximum of 100 mg/day (or to the maximal tolerated dose). Study drug was administered daily in equally divided twice daily doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean monthly number of headache days with moderate or severe intensity | a day with headache pain that lasts ≧ 4 h with peak severity of moderate or severe intensity, or any severity or duration if the subject takes and response to a triptan or ergot. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity |  | 3 months | 
| Mean monthly total headache days |  | 3 months | 
| Reduction from baseline in the use of acute headache medications |  | 3 months | 
| Short-Form 36-Item Health Survey(SF-36) |  | 3 months | 
| Beck Depression Inventory(BDI) |  | 3 months | 
| Migraine disability assessment questionnaire (MIDAS) |  | 3 months | 
| Plasma CGRP level |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic migraine, acupuncture, Topiramate, Randomized trial