Gaul Charly, Diener Hans-Christoph, Danesch Ulrich
Migraine and Headache Clinic, Königstein im Taunus, Germany,
J Headache Pain. 2015;16:516. doi: 10.1186/s10194-015-0516-6. Epub 2015 Apr 3.
Non-medical, non-pharmacological and pharmacological treatments are recommended for the prevention of migraine. The purpose of this randomized double-blind placebo controlled, multicenter trial was to evaluate the efficacy of a proprietary nutritional supplement containing a fixed combination of magnesium, riboflavin and Q10 as prophylactic treatment for migraine.
130 adult migraineurs (age 18 - 65 years) with ≥ three migraine attacks per month were randomized into two treatment groups: dietary supplementation or placebo in a double-blind fashion. The treatment period was 3 months following a 4 week baseline period without prophylactic treatment. Patients were assessed before randomization and at the end of the 3-month-treatment-phase for days with migraine, migraine pain, burden of disease (HIT-6) and subjective evaluation of efficacy.
Migraine days per month declined from 6.2 days during the baseline period to 4.4 days at the end of the treatment with the supplement and from 6.2.days to 5.2 days in the placebo group (p = 0.23 compared to placebo). The intensity of migraine pain was significantly reduced in the supplement group compared to placebo (p = 0.03). The sum score of the HIT-6 questionnaire was reduced by 4.8 points from 61.9 to 57.1 compared to 2 points in the placebo-group (p = 0.01). The evaluation of efficacy by the patient was better in the supplementation group compared to placebo (p = 0.01).
Treatment with a proprietary supplement containing magnesium, riboflavin and Q10 (Migravent® in Germany, Dolovent® in USA) had an impact on migraine frequency which showed a trend towards statistical significance. Migraine symptoms and burden of disease, however, were statistically significantly reduced compared to placebo in patients with migraine attacks.
推荐采用非医学、非药物及药物治疗方法预防偏头痛。这项随机双盲安慰剂对照多中心试验的目的是评估一种含有镁、核黄素和辅酶Q10固定组合的专利营养补充剂作为偏头痛预防性治疗的疗效。
130名每月有≥3次偏头痛发作的成年偏头痛患者(年龄18 - 65岁)被随机分为两个治疗组:双盲方式下的膳食补充剂组或安慰剂组。在4周无预防性治疗的基线期后,治疗期为3个月。在随机分组前以及3个月治疗阶段结束时,对患者的偏头痛天数、偏头痛疼痛程度、疾病负担(HIT - 6)和疗效主观评估进行了评估。
补充剂治疗结束时,每月偏头痛天数从基线期的6.2天降至4.4天,安慰剂组从6.2天降至5.2天(与安慰剂相比,p = 0.23)。与安慰剂相比,补充剂组偏头痛疼痛强度显著降低(p = 0.03)。HIT - 6问卷总分从61.9分降至57.1分,降低了4.8分,而安慰剂组降低了2分(p = 0.01)。与安慰剂相比,患者对补充剂组疗效的评估更好(p = 0.01)。
含镁、核黄素和辅酶Q10的专利补充剂(德国的Migravent®,美国的Dolovent®)治疗对偏头痛发作频率有影响,具有统计学显著意义的趋势。然而,与安慰剂相比,偏头痛发作患者的偏头痛症状和疾病负担在统计学上显著降低。