Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos
Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos
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DOI：
10.1007/s004150050560
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发表时间：
2000-03-01
影响因子：
6
通讯作者：
Kleijnen, J
中科院分区：
文献类型：
--
作者：
de Craen, AJM;Tijssen, JGP;Kleijnen, J
我们对22个试验进行了荟萃分析，以确定(A)皮下给药与口服给药和(B)医院内给药与家庭给药在偏头痛治疗中的比较安慰剂效果。头痛缓解率来自这些随机临床试验的安慰剂，评估舒马曲坦在偏头痛急性治疗中的价值。主要的结果衡量标准是在治疗开始后2小时将患者从重度或中度头痛重新分类为无或轻度头痛的比例。在口服方案中，865名患者中有222名(25.7%)在2小时后报告没有或轻度头痛严重，相比之下，接受皮下安慰剂治疗的862名患者中有279名(32.4%)(差异6.7%；95%可信区间2.4-11.0%)。调整基线时的治疗设置和头痛严重程度不会改变观察到的差异。在家中接受安慰剂治疗后，1054名患者中有285名(27.0%)在2小时后没有或轻度头痛，相比之下，在医院接受安慰剂治疗的673名患者中有216名(32.1%)(差异5.1%；95%可信区间0.6-9.5%)。当根据基线时的给药途径和头痛严重程度进行调整后，家庭和医院环境之间的缓解率差异消失。这些发现表明，皮下给药增强了偏头痛急性治疗的安慰剂效果。未来评估不同给药途径的相对疗效的抗偏头痛药物试验应该使用双模拟技术。因此，对安慰剂对照试验结果的解释必须考虑到试验在药物方面的效果部分取决于给药途径。
We carried out a metaanalysis of 22 trials to determine the comparative placebo effect of (a) subcutaneous vs, oral and (b) in-hospital vs, at-home administration in the treatment of migraine. The headache relief rates were combined from the placebo arms of these randomised clinical trials assessing the value of sumatriptan in acute treatment of migraine. The main outcome measure was the proportion of patients reclassified from severe or moderate headache severity to no or mild headache severity 2 h after the beginning of treatment. In the oral regimen 222 of 865 patients (25.7%) reported no or mild headache severity after 2 h, compared to 279 of 862 patients (32.4%) of those :receiving subcutaneous placebo (6.7% difference; 95% CI 2.4-11.0%). Adjusting for treatment setting and severity of headache at baseline did not change the observed difference. After placebo treatment at home 285 of 1054 patients (27.0%) reported no or mild headache severity after 2 h, compared to 216 of 673 patients (32.1%) among those receiving placebo in hospital (5.1% difference; 95% CI 0.6-9.5%). When adjusted for route of administration and severity of headache at baseline, the difference in relief rates between home and hospital setting disappeared. These findings indicate that subcutaneous administration enhances the placebo effect of acute treatment of migraine. Future trials of antimigraine drugs assessing the relative efficacy of various routes of administration should use a double-dummy technique. The interpreting of placebo-controlled trial results must therefore consider that the effect in the drug arm of the trial depends in part on the route of administration.