A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 132
- 主要终点
- the number of days with migraine headache at the 3rd Month
研究概览
简要总结
Adult patients suffering from migraine according to the criteria of the International Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous month; exclusion of chronic migraine and medication overuse) and after a one-month baseline phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg magnesium per day for 3 months.
详细描述
Three visits were planned: V1, V2 on Day 30 (± 10) and V3 on Day 120 (± 10). On V1, after checking the inclusion criteria and receiving informed consent, GPs collected demographic data, medical and migraine history and information on migraine attacks, associated symptoms and rescue medications via an electronic case report form. V1 was followed by a one-month observation period (baseline phase) during which migraine treatment of patients was not modified. From V1 till the end of the study, all patients kept an electronic diary in which they reported migraine characteristics (number of days with migraine headache, intensity, associated symptoms and concomitant medications). On the second visit (V2; Day 30 ± 10), eligibility of patients was verified: patients with less than 2 or more than 15 migraine attacks during baseline phase and patients unwilling to be supplemented with the combination were excluded from the study. Eligible patients were advised to start supplementation. On V3 (Day 120 ± 10), information provided in patient's diary and compliance with supplementation were checked.
The day before V2 and V3, patients had to complete the French migraine-related quality of life questionnaire (Qualité de Vie et Migraine [QVM]) and the Hospital Anxiety and Depression Scale (HADS).
The study was conducted in accordance with articles L.1121-1 and R1121-2 of the French public health code defining non interventional studies; all the acts were practised and products used in a usual way without any additional or unusual procedure of diagnosis or surveillance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)
- •to suffer from migraine for more than one year
- •to be less than 50 years old at migraine onset
- •to have had at least two migraine attacks during the month before recruitment
排除标准
- •migraine with aura with motor symptoms (hemiplegic migraine)
- •more than 15 migraine attacks per month
- •abuse of painkillers defined as the use of paracetamol, aspirin and non-steroid anti-inflammatory drugs for more than 15 days per month over the last three months or the use of triptans, opioids and ergot-type medications for more than 10 days per month during the last three months
- •prophylactic treatment taken for less than 3 months
结局指标
主要结局
the number of days with migraine headache at the 3rd Month
时间窗: 3rd month of supplementation
次要结局
- Number of days with migraine headache per month(during the 3rd month)
- Intensity of migraine headache evaluated with a 5 points Likert Scale(during the 3rd month)
- Associated symptoms evaluated with Scorecard of potential symptoms(during the 1st month)
- Anxiety and depression evaluated with DNS (Dopa Nora Sero) questionnaire(during the 3rd month)
- Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire(end of the 3rd month)
- Compliance followed with patient logbook(3 months)
- Safety followed with side effects register(3 months)