Limmroth Volker, Biondi David, Pfeil Joop, Schwalen Susanne
Department of Neurology, Cologne City Hospitals, Cologne, Germany.
Headache. 2007 Jan;47(1):13-21. doi: 10.1111/j.1526-4610.2007.00648.x.
The aim was to evaluate whether preventive treatment with topiramate in patients with episodic migraine reduces the risk of developing chronic forms of headache.
Chronic forms of headache, including chronic migraine or medication overuse headache (MOH), are characterized by 15 or more headache days per month. Acute medication overuse has been shown to be a risk factor for developing chronic headache, but it is not known whether preventive treatment can reduce the risk of developing chronic forms of headache or the development of MOH.
Pooled data from 3 trials in patients with episodic migraine randomized either to treatment with 100 mg topiramate per day (n = 384) or with placebo (n = 372) were analyzed with regard to the number of headache days during a prospective 4-week baseline period and the individual final 4 weeks of each patient's treatment during the planned 26-week double-blind treatment period.
The number of headache days per month in the topiramate versus the placebo-treated groups was 7.3 +/- 3.0 versus 7.3 +/- 3.1 during baseline and 4.1 +/- 4.2 versus 5.6 +/- 4.9 during the final 4 weeks, respectively (P < .001). At the end of the study, 8 versus 16 patients fulfilled International Headache Society criteria of chronic headache (odds ratio: 2.11, P= .082). Moreover, a significantly lower number of patients receiving topiramate treatment reported an increase in headache days per month by the end of the study when compared to placebo (66 vs 88 patients, respectively; odds ratio: 1.49, P < .05). Finally, the number of days with usage of acute medication was significantly lower in the topiramate arm compared with placebo (3.3 +/- 3.7 vs 4.3 +/- 3.6, respectively; P < .001).
Preventive treatment with topiramate in patients with episodic migraine may reduce the risk of developing chronic forms of headache.
评估托吡酯预防性治疗发作性偏头痛患者是否能降低慢性头痛形式的发生风险。
慢性头痛形式,包括慢性偏头痛或药物过量使用性头痛(MOH),其特征为每月头痛天数达15天或更多。急性药物过量已被证明是慢性头痛发生的一个危险因素,但预防性治疗是否能降低慢性头痛形式或MOH的发生风险尚不清楚。
对3项试验的汇总数据进行分析,这些试验中发作性偏头痛患者被随机分为每日服用100mg托吡酯治疗组(n = 384)或安慰剂组(n = 372),分析前瞻性4周基线期的头痛天数以及计划的26周双盲治疗期内每位患者治疗最后4周的头痛天数。
在基线期,托吡酯治疗组与安慰剂治疗组每月的头痛天数分别为7.3±3.0天和7.3±3.1天;在最后4周,分别为4.1±4.2天和5.6±4.9天(P <.001)。研究结束时,符合国际头痛协会慢性头痛标准的患者,托吡酯治疗组为8例,安慰剂组为16例(比值比:2.11,P =.082)。此外,与安慰剂相比,接受托吡酯治疗的患者在研究结束时每月头痛天数增加的人数显著减少(分别为66例和88例;比值比:1.49,P <.05)。最后,托吡酯组急性药物使用天数显著低于安慰剂组(分别为3.3±3.7天和4.3±3.6天;P <.001)。
托吡酯预防性治疗发作性偏头痛患者可能降低慢性头痛形式的发生风险。