Effectiveness of high-dose riboflavin in migraine prophylaxis - A randomized controlled trial
Effectiveness of high-dose riboflavin in migraine prophylaxis - A randomized controlled trial
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DOI：
10.1212/wnl.50.2.466
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发表时间：
1998-02-01
期刊：
影响因子：
9.9
通讯作者：
Lenaerts, M
中科院分区：
文献类型：
--
作者：
Schoenen, J;Jacquy, J;Lenaerts, M
线粒体能量代谢的缺陷可能在偏头痛发病机制中起作用。我们在以前的一项开放性研究中发现，大剂量核黄素对预防偏头痛有效。我们现在比较了核黄素（400毫克）和安慰剂在55例偏头痛患者在一个为期3个月的随机试验。使用意向治疗分析，核黄素在减少发作频率（p = 0.005）和头痛天数（p = 0.012）方面优于安慰剂（上级）。对于后者，改善至少50%的患者比例，即“应答者”，安慰剂组为15%，核黄素组为59%（p = 0.002），有效性所需治疗的人数为2.3。发生了三起轻微的不良事件，核黄素组有两起（腹泻和多尿），安慰剂组有一起（腹部绞痛）。没有一个是认真的。由于其高疗效，良好的耐受性和低成本，核黄素是一个有趣的选择偏头痛预防和候选人的比较试验与一个既定的预防药物。
A deficit of mitochondrial energy metabolism may play a role in migraine pathogenesis. We found in a previous open study that high-dose riboflavin was effective in migraine prophylaxis. We now compared riboflavin (400 mg) and placebo in 55 patients with migraine in a randomized trial of 3 months duration. Using an intention-to-treat analysis, riboflavin was superior to placebo in reducing attack frequency (p = 0.005) and headache days (p = 0.012). Regarding the latter, the proportion of patients who improved by at least 50%, i.e. "responders," was 15% for placebo and 59% for riboflavin (p = 0.002) and the number-needed-to-treat for effectiveness was 2.3. Three minor adverse events occurred, two in the riboflavin group (diarrhea and polyuria) and one in the placebo group (abdominal cramps). None was serious. Because of its high efficacy, excellent tolerability, and low cost, riboflavin is an interesting option for migraine prophylaxis and a candidate for a comparative trial with an established prophylactic drug.