Acupuncture for Prophylaxis of Vestibular Migraine

Study Overview
=================
Brief Summary
-----------------
With its high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect patients' quality of life. Current treatment of VM mainly contain rescue treatment and prophylaxis, both of which are often pharmacological-based therapies and bring a series of unavoidable side effects, which leads to poor compliance of patients. Moreover, frequent VM attacks can seriously affect patients' daily life and work. Therefore, prophylaxis treatment is of great significance for VM patients. As a non-pharmarceutical therapy, acupuncture is widely used for a wide range of migrainous and emotional disorders. Thus, it might be an alternative treatment for VM, but current evidence remains inconclusive. The aim of this randomized controlled trial is to investigate the prophylactic efficacy and safety of acupuncture therapy in patients with VM.

Detailed Description
-----------------
This randomized controlled trial will enroll patients with vestibular migraine from the First Affiliated Hospital of Jiaxing University. All participants will be randomly assigned to two groups. Participants will receive acupuncture in the treatment group, while participants in the control group will be treated by venlafaxine. All treatments will be given for 8 weeks. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in dosage of rescue medication, anxiety level，depression level，and quality of life per 4 weeks from baseline.

Official Title
-----------------
The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine

Conditions
-----------------
Vestibular Migraine

Intervention / Treatment
-----------------
* Procedure: Acupuncture
* Drug: Venlafaxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age 18 to 80 , male or female; Patients meet the criteria proposed by the collaboration of Barany Society and the International Headache Society in 2012; Vertigo/migraine attacks at least 3 times per month in the last 3 months; or vertigo/migraine days are at least 4 days per month; Patients have unsatisfactory response to rescue treatments and seek for preventive treatments; Patients can fully understand the study protocol and agree to sign written informed consent forms. Exclusion Criteria: Patients'vertigo and headache are caused by other diseases, such as vestibular neuritis, Meniere disease, tension headache, and other cerebrovascular diseases. Patients have prophylactic headache treatment with drugs in the past 3 months. Patients are receiving adjunctive therapy that is not widely accepted for treating VM, such as Chinese herbs. Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems that are not controlled significantly; Pregnant and lactating female patients; Patients have mental illness that affects cognitive function.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>Patients in this group will receive acupuncture once every other day (3 days per week) over an 8-week period (a total of 24 sessions). | Procedure: Acupuncture<br>* Patients in this group will receive acupuncture once every other day (3 days per week) over an 8-week period (a total of 24 sessions). In each session, needles will be retained for 30 minutes. The acupoints will include Baihui (DU20), Qianding (DU21), Houding (DU19), Yintang (DU29), Fengchi (GB20), Shuaigu (GB8), Tongli (HT5), Hegu (LI4), Taichong (LR3), Fenglong (ST40), Xuanzhong (GB39) and Zulinqi (GB41). The selection of acupoints is on the basis of meridian theory and patients' clinical symptoms. Patients are not allowed to take prophylactic medications. But in case of intolerable acute VM attacks, the patients will be instructed to take triptans as rescue medication, and the dosage of medication will be documented in the patient diary.<br>|
| Active Comparator: Medication group<br>Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks. | Drug: Venlafaxine<br>* Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks. In case of intolerable acute VM attacks, the patients will be instructed to take triptans as rescue medication, and the dosage of medication will be documented.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of vertigo/migraine days and vertigo/migraine attacks | The number of vertigo/migraine days and vertigo/migraine attacks will be assessed by a patient diary. | 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up | 
| Change in vertigo severity | Vertigo severity will be measured by dizziness handicap inventory (DHI) | 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up | 
| Change in migraine intensity | Migraine intensity will be measured by visual analogue scale (VAS) | 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in doses of rescue medication | Doses of rescue medication (triptans) will be documented by patients in the patient diary. | 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up | 
| Change in anxiety level | Anxiety level will be measured by Generalized Anxiety Disorder-7 (GAD-7) scale. | 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up | 
| Change in depression level | Depression level will be measured by Patient Health Questionnaire (PHQ-9) scale | 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up | 
| Change in quality of life | Quality of life will be measure by 36-item short form health survey (SF-36). | 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vestibular migraine, randomized controlled trial, acupuncture