Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.
Acta Neurol Scand. 2013 Jul;128(1):65-72. doi: 10.1111/ane.12081. Epub 2013 Feb 13.
This study compares efficacy and safety of divalproate extended release (DVA-ER) and amitriptyline (AMT) in migraine.
Three hundred migraineurs having >4 attacks monthly were randomized into DVA-ER or AMT. The primary end points were >50% reduction in frequency, ≥1 grade improvement in the severity, and >50% improvement in a visual analogue scale (VAS). Secondary end points were functional disability, rescue medication, and adverse events.
The median age was 32 years, and 241 were women. 150 patients each received DVA-ER and AMT. At 3 months, 74.7% in DVA-ER and 62% patients in AMT group improved in headache frequency (P = 0.02) and at 6 months, 65.3% and 54%, respectively (P = 0.90). At 3 months, the VAS score improved by >50% in 80.7% in DVA-ER and 64% in AMT (P = 0.005). At 6 months, there was no significant difference between the two groups in VAS score (69.3% vs 56%; P = 0.47) and other outcome parameters. The composite side effects were also not different between the two groups (68% vs 81%); however, hair fall, menstrual irregularity, polycystic ovary, and weight gain were commoner in DVA-ER group.
Divalproate extended release is more effective at 3 months than AMT; however, at 6 months, both are equally effective in migraine prophylaxis.
本研究比较了丙戊酸钠缓释片（DVA-ER）和阿米替林（AMT）在偏头痛中的疗效和安全性。
300 名每月偏头痛发作次数大于 4 次的患者被随机分为 DVA-ER 组或 AMT 组。主要终点为频率减少 50%以上、严重程度提高 1 级以上和视觉模拟量表（VAS）改善 50%以上。次要终点为功能障碍、抢救药物和不良事件。
中位年龄为 32 岁，241 名为女性。每组 150 名患者分别接受 DVA-ER 和 AMT 治疗。3 个月时，DVA-ER 组的 74.7%和 AMT 组的 62%患者头痛发作频率改善（P=0.02），6 个月时，分别为 65.3%和 54%（P=0.90）。3 个月时，DVA-ER 组 VAS 评分改善>50%的比例为 80.7%，AMT 组为 64%（P=0.005）。6 个月时，两组 VAS 评分（69.3% vs 56%；P=0.47）和其他结局参数无显著差异。两组的复合不良反应也无差异（68% vs 81%）；然而，DVA-ER 组更常见脱发、月经不规律、多囊卵巢和体重增加。
丙戊酸钠缓释片在 3 个月时比 AMT 更有效；然而，6 个月时，两者在偏头痛预防中同样有效。
