Omega-3 Fatty Acid in the Prevention of Migraine: From the Randomized Clinical Trial to Molecular Biology Approaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Reduction of migraine attacks during the 12-week period [Efficacy]
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 20 to 65 years old
- •A diagnosis based on the International Classification of Headache Disorders (ICHD-3)
- •An established migraine history for at least 1 year
- •Independent from the study
- •Written informed consent
排除标准
- •Chronic migraine
- •Headaches other than migraine
- •Use any of the following drugs in the past four weeks：
- •Migraine prophylaxis agents
- •Anti-depressants
- •Calcium channel blockers
- •Anti-epileptic agents
- •Cycle-modulating hormonal drugs
- •Onabotulinumtoxin A (Botox) injection
- •Migraine onset after the age of 50
- •Emerging abnormal findings on：
- •Laboratory parameters
- •Physical examination
- •Suicidal risks
- •Severe depression
- •Cognitive impairment
- •Allergies or hypersensitivity to fish or omega-3 fatty acids
- •Bleeding diathesis or using anticoagulation agents
- •Pregnancy or nursing
结局指标
主要结局
Reduction of migraine attacks during the 12-week period [Efficacy]
时间窗: 12 weeks
The primary end point is the mean change from baseline (28-day pretreatment period) in the mean number of monthly migraine days during the 12-week period. A migraine day was defined as (a day with headache pain that lasted 4 hours with a peak severity of moderate or severe intensity, or any severity or duration if the participant took and responded to a triptan or ergot) from the second to the fourth diaries compared with the first diary (baseline period).
次要结局
- Hospital Anxiety and Depression Scale (HADS)(12 weeks)
- 50% reduction of migraine attacks(12 weeks)
- Migraine Disability Assessment Score (MIDAS)(12 weeks)
- The Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity (PGI-S)(12 weeks)
- The Beck Depression Inventory-II (BDI-II)(12 weeks)
- Reduction of acute headache medications(12 weeks)
- Migraine Quality of Life Questionnaire (MSQ) scores(12 weeks)
- Pittsburgh Sleep Quality Questionnaire (PSQI) scores(12 weeks)
- Reduction of accumulative headache hours(12 weeks)
研究者
Chun-pai Yang, MD
Director
Kuang Tien General Hospital