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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
72
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.
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.
The First Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, China
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.
Time frame: 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)
Time frame: 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)
Time frame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Change in doses of rescue medication
Doses of rescue medication (triptans) will be documented by patients in the patient diary.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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