Vikelis Michail, Dermitzakis Emmanouil V, Vlachos George S, Soldatos Panagiotis, Spingos Konstantinos C, Litsardopoulos Pantelis, Kararizou Evangelia, Argyriou Andreas A
Headache Clinic, Mediterraneo Hospital, 16675 Glyfada, Greece.
Glyfada Headache Clinic, 16675 Glyfada, Greece.
J Clin Med. 2020 Dec 27;10(1):67. doi: 10.3390/jcm10010067.
To investigate the efficacy and safety of supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 in episodic migraine (EM) prevention.
A pilot, single-arm, open-label study was conducted. After a one-month baseline period, the above-described supplementation was introduced in 113 EM Greek patients, who were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BSL) and the third month of supplementation (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), Migraine-Specific Quality-of-life questionnaire (MSQ-QOL), Hospital Anxiety and Depression Scale (HADS) were also evaluated. Those with ≥50% reduction in monthly migraine days at T3, compared to BSL were considered supplementation-responders.
The mean number of migraine days was significantly decreased between BSL and T3 (9.4 ± 3.7 vs. 6.1 ± 3.5; < 0.001). Likewise, days with peak headache intensity of >4/10 (5.7 ± 3.4 vs. 4.9 ± 3.1; < 0.001) as well as days using acute headache medications per month (8.9 ± 3.6 vs. 5.7 ± 3.4; < 0.001) were significantly reduced. At T3, 64 patients (56.6%) were classified as responders. The beneficial effect of supplementation was also associated with significant changes in HIT-6, MIDAS, MTAQ and MSQ-QOL scores. There were no safety concerns.
The supplementation we have tested appears to be an effective and well-tolerated preventive approach against EM. A randomized, placebo-controlled study is needed to confirm our results.
研究补充镁、维生素B2、小白菊、穿心莲和辅酶Q10的固定组合预防发作性偏头痛（EM）的疗效和安全性。
进行了一项试点单臂开放标签研究。在为期一个月的基线期后，113例希腊EM患者开始上述补充治疗，并进行了为期三个月的前瞻性随访。主要终点是基线期（BSL）与补充治疗第三个月（T3）之间每月偏头痛天数的变化。次要终点包括偏头痛平均强度的变化以及使用急性偏头痛药物的天数变化。还评估了偏头痛残疾评估问卷（MIDAS）、头痛影响测试-6（HIT-6）、偏头痛治疗评估问卷（MTAQ）、偏头痛特异性生活质量问卷（MSQ-QOL）、医院焦虑抑郁量表（HADS）的评分变化。与BSL相比，T3时每月偏头痛天数减少≥50%的患者被视为补充治疗反应者。
BSL和T3之间偏头痛天数的平均值显著降低（9.4±3.7对6.1±3.5；<0.001）。同样，头痛强度峰值>4/10的天数（5.7±3.4对4.9±3.1；<0.001）以及每月使用急性头痛药物的天数（8.9±3.6对5.7±3.4；<0.001）也显著减少。在T3时，64例患者（56.6%）被归类为反应者。补充治疗的有益效果还与HIT-6、MIDAS、MTAQ和MSQ-QOL评分的显著变化相关。没有安全问题。
我们测试的补充治疗似乎是一种有效且耐受性良好的预防EM的方法。需要进行一项随机安慰剂对照研究来证实我们的结果。
