Background

Pain freedom after 2 hours is the recommended primary endpoint by the International Headache Society in randomized trials investigating drug treatment of acute migraine attacks. In order to demonstrate an early effect of a drug, some drug companies, however, have promoted headache relief (improvement from severe or moderate pain to mild or no pain) at earlier time points than 2 hours as outcome parameter.

Methods and results

We analyzed the relationship between pain freedom and headache relief in acute migraine trials and observed that persistent mild headache constituted 90% of headache relief after 0.5 hour and 40% of headache relief after 2 hours.

Conclusion

Headache relief at 2 hours should in our view only be used as an outcome measure for comparison with historic data. Prior to 2 hours, headache relief varies with time from intake and the therapeutic gain is very small. Therefore, pain freedom should be used at these early time points.

中文翻译：

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在治疗偏头痛发作的对照试验中，2 小时后无疼痛应该是主要结果。

背景

在调查急性偏头痛发作的药物治疗的随机试验中，2 小时后疼痛消失是国际头痛协会推荐的主要终点。然而，为了证明药物的早期效果，一些制药公司已经将头痛缓解（从重度或中度疼痛改善为轻度或无痛）作为结果参数在 2 小时之前的时间点进行。

方法和结果

我们在急性偏头痛试验中分析了无痛与头痛缓解之间的关系，并观察到持续轻度头痛构成 0.5 小时后头痛缓解的 90% 和 2 小时后头痛缓解的 40%。

结论

在我们看来，2 小时的头痛缓解应仅用作与历史数据进行比较的结果衡量标准。在 2 小时之前，头痛缓解随摄入时间而变化，治疗收益非常小。因此，应在这些早期时间点使用无痛。