Omega-3 Fatty Acid in the Prevention of Migraine
Condition: Migraine; Omega-3 Polyunsaturated Fatty Acids
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      To understand the clinical efficacy for omega-3 PUFAs migraine prevention.To uncover the
      underlying biochemical or neurophysiological mechanisms by which omega-3 PUFAs for migraine
      prevention.
    

Detailed description: 
      Background:

      Migraine is a common disabling disorder and its substantial burden is associated with
      considerable negative impact on quality of life. Several pharmacological treatments are
      available for migraine prophylaxis but insufficient efficacy and significant side effects
      preclude their widely use for migraine treatment. In recent years, more attention has been
      paid to dietary supplements and natural ingredients for the treatment of migraine. Omega-3
      polyunsaturated fatty acids (omega-3 PUFAs) have beneficial on the reduction of neurogenic,
      perivascular inflammations and pro-inflammatory cytokines, which may play an important role
      in the pathophysiology of migraine. However, the results of investigations carried out about
      the clinical efficacy of omega-3 PUFAs in the management of migraine are inconsistent.

      Purpose:

      To understand the clinical efficacy for omega-3 PUFAs migraine prevention. To uncover the
      underlying biochemical or neurophysiological mechanisms by which omega-3 PUFAs for migraine
      prevention

      Method:

      This two-year project includes clinical approaches to investigate the therapeutic effects of
      omega-3 PUFAs on episodic migraine (4-14 days/month) without migraine preventive treatment in
      the past one month. 120 patients, aged 20-65, will be randomized in a 12-week, double-blind,
      placebo-controlled trial comparing the effects of high-dose eicosapentaenoic acid (EPA,
      1.8g/day) and placebo intervention. All participants will complete a set of outcome measures:
      headache questionnaires and headache diary, the Migraine Disability Assessment (MIDAS),
      patient overall impression questionnaire-migraine improvement questionnaire (PGI-I), patient
      overall impression questionnaire-migraine severity questionnaire (PGI-S), Beck Depression
      Inventory-II (BDI-II), Hospital anxiety and depression scale (HADS), Migraine Quality of Life
      Questionnaire (MSQ), Pittsburgh Sleep Quality Questionnaire (PSQI) at baseline and the
      follow-up visits before and after 12 weeks of placebo or omega-3 PUFAs intervention (EPA, 1.8
      g/day) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation.
      The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and
      the end of the intervention.

      Expected results:

      To establish the clinical evidence of omega-3 PUFAs on migraine prevention. To provide
      significant insights into molecular actions of omega-3 PUFAs on migraine prevention.
    

Intervention name(s): Omega-3 polyunsaturated fatty acids; omega-6 PUFAs
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of omega-3 PUFAs intervention (EPA, 1.8 g/day) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.; All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of placebo omega-6 PUFAs intervention and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention