Comparison of Propranolol and Venlafaxine in Treatment of Vestibular Migraine
Condition: Vestibular Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The presented study aims to compare effectivity of propranolol with effectivity of
      venlafaxine in escalating dose in subjects with vestibular migraine (VM) over a period of 12
      weeks. The study population consisted of subjects diagnosed definite VM according to criteria
      of Bárány Society and Migraine Classification Subcommittee of the International Headache
      Society (IHS). Effectivity of therapy was measured by Dizziness Handicap Inventory (DHI),
      number of vertiginous attack of last month and visual analogue scale (VAS) reported dizziness
      related Quality of Life (QOL). Beck Anxiety Inventory (BAI) and Beck Depression Inventory
      (BDI) were also used to determine psychiatric improvement played role in response to therapy
      in venlafaxine treatment arm.
    

Detailed description: 
      Vestibular migraine (VM) is a condition of episodic vertigo linked to migrainous symptoms
      described by Nueuhauser et al. in 2001. Some subjects benefit behavior and diet modification
      and controls of their symptoms. Anti-migrainous medication for prophylactic aim is given
      subjects who do not benefit life-style improvement. However, there is absence of sufficient
      evidence for treatment of VM.

      In this study the investigators aimed to evaluated effectiveness of prophylactic treatment
      venlafaxine by comparing propranolol in VM. The investigators also aimed to investigate if
      the effectiveness of venlafaxine is linked to the improvement of psychiatric condition.

      All subjects who were suspected to having VM referred to both M.S. (Department of
      Otolaryngology) and H.A. (Department of Neurology) in order to ensure subjects fill the
      criteria of VM and did not have other vestibular disorders. All subjects underwent detailed
      neurologic, neurotologic examination, audiometric investigation, videonystagmography (VNG)
      and bithermal caloric testing in order to exclude other or additional vestibular or
      neurologic disease. Subjects who were18 years or old with a history of (at least 2 months)
      definite VM according to criteria of Bárány Society and Migraine Classification Subcommittee
      of the International Headache Society (IHS) were eligible for this study. After a subject
      fill the eligibility criteria of the study who did not respond to lifestyle or dietary
      modification were enrolled to the study.

      Subjects were enrolled to the study if they filled to the inclusion and exclusion criteria
      and written informed consent was obtained from all subjects. Subjects were randomized using
      sealed envelop methods by A.K. (Department of Otolaryngology). Before starting intervention
      protocol Dizziness Handicap Inventory (DHI), number of vertiginous attack of last month and
      visual analogue scale (VAS) reported dizziness related Quality of Life (QOL), Beck Anxiety
      Inventory (BAI) and Beck Depression Inventory (BDI) were obtained from all subjects by T.Y.
      (Department of Otolaryngology). Subjects were given propranolol or venlafaxine treatment
      according to randomization with balanced allocation (1:1). The study was unblinded because
      the study is not an investigational and propranolol was paid by government health insurance.
      However, venlafaxine is not paid for the migraine therapy by government health insurance and
      venlafaxine was provided by Institution Research Funding System.

      The intervention protocol was carried on by T.Y. under supervision of H.A and M.S..
      Propranolol was given in a flexible dose between 40 mg to 160 mg with an escalating fashion
      starting at 40 mg PO AM for one week and followed by 40 mg AM and 40 mg PM for a total dose
      up to 160 mg daily. Venlafaxine treatment was followed as: 37.5 mg qhs for two weeks and
      followed 75 mg qhs with an escalating dose with 2 weeks periods up to 150 mg daily. All
      participants were asked to self-titrate their medication in case if inform the researchers.
      Subjects were to be seen at the clinic biweekly for first month in order to evaluated adverse
      effects and to make sure participants were having sufficient dosage. The effective duration
      of the treatment was considered as 3 months and participants were asked to continue using
      their medication one more month in order to evaluate change from baseline to 3rd month in
      terms of number of vertiginous attacks of the last month. All participants were assessed at
      the clinic at month 1, 3 and 4. Change from baseline DHI, VAS, BAI and BDI were scored at 4th
      month.

      Adverse effects, reason to exclude the subjects from the study, reason subjects refused to
      continue the study and other reasons subjects could not follow the protocol were all recorded
      during clinic visits or obtained over the phone at home.

      The analysis primary endpoint was performed following the intention-to-treat (ITT) method.
      Missing data was handled by multiple imputation method.
    

Intervention name(s): Propranolol; Venlafaxine
Intervention type(s): Drug; Drug
Intervention description(s): Propranolol was given in a flexible dose between 40 mg to 160 mg with an escalating fashion starting at 40 mg PO AM for one week and followed by 40 mg AM and 40 mg PM for a total dose up to 160 mg daily; Venlafaxine treatment was followed as: 37.5 mg qhs for two weeks and followed 75 mg qhs with an escalating dose with 2 weeks periods up to 150 mg daily
Other intervention name(s): Dideral; Efexor
Intervention MeSH terms: Propranolol; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Migrainous Vertigo; Headache Disorders; Central Nervous System Origin Vertigo; Paroxysmal Vertigo; Adrenergic beta-Antagonist; Vasodilator Agent; Anti Arrhythmia Agent; Serotonin Uptake Inhibitor; Antidepressive Agent; Propranolol; Venlafaxine