Buettner Catherine, Nir Rony-Reuven, Bertisch Suzanne M, Bernstein Carolyn, Schain Aaron, Mittleman Murray A, Burstein Rami
Department of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.
Department of Neurology, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
Ann Neurol. 2015 Dec;78(6):970-81. doi: 10.1002/ana.24534. Epub 2015 Nov 13.
The aim of this work was to assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine.
We performed a randomized, double-blind, placebo-controlled trial with a 12-week baseline period and 24-week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice-daily plus vitamin D3 1,000 international units capsules twice-daily or matching placebo tablets and capsules.
Compared to placebo, participants using simvastatin plus vitamin D3 demonstrated a greater decrease in number of migraine days from the baseline period to intervention weeks 1 to 12: a change of -8.0 (interquartile range [IQR]: -15.0 to -2.0) days in the active treatment group versus +1.0 (IQR: -1.0 to + 6.0) days in the placebo group, p < 0.001; and to intervention weeks 13 to 24: a change of -9.0 (IQR: -13 to -5) days in the active group versus +3.0 (IQR: -1.0 to + 5.0) days in the placebo group, p < 0.001. In the active treatment group, 8 patients (25%) experienced 50% reduction in the number of migraine days at 12 weeks and 9 (29%) at 24 weeks postrandomization. In comparison, only 1 patient (3%) in the placebo group (p = 0.03) experienced such a reduction. Adverse events were similar in both active treatment and placebo groups.
The results demonstrate that simvastatin plus vitamin D is effective for prevention of headache in adults with episodic migraine. Given statins' ability to repair endothelial dysfunction, this economical approach may also reduce the increased risk for vascular diseases among migraineurs.
本研究旨在评估辛伐他汀联合维生素D预防成人发作性偏头痛的疗效和耐受性。
我们对57例成人发作性偏头痛患者进行了一项随机、双盲、安慰剂对照试验，基线期为12周，干预期为24周。参与者被随机分配至每日两次服用20毫克辛伐他汀片加每日两次服用1000国际单位维生素D3胶囊组，或匹配的安慰剂片和胶囊组。
与安慰剂相比，使用辛伐他汀联合维生素D3的参与者从基线期到干预第1至12周偏头痛天数的减少幅度更大：活性治疗组变化为-8.0（四分位间距[IQR]：-15.0至-2.0）天，而安慰剂组为+1.0（IQR：-1.0至+6.0）天，p<0.001；到干预第13至24周：活性组变化为-9.0（IQR：-13至-5）天，安慰剂组为+3.0（IQR：-1.0至+5.0）天，p<0.001。在活性治疗组中，8例患者（25%）在随机分组后12周时偏头痛天数减少了50%，9例（29%）在24周时减少。相比之下，安慰剂组只有1例患者（3%）（p=0.03）有这样的减少。活性治疗组和安慰剂组的不良事件相似。
结果表明，辛伐他汀联合维生素D对预防成人发作性偏头痛有效。鉴于他汀类药物修复内皮功能障碍的能力，这种经济的方法也可能降低偏头痛患者血管疾病增加的风险。
