Headache Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain.
Headache and Neurological Pain Research Group, VHIR, Universitat Autonoma of Barcelona, Barcelona, Spain.
Cephalalgia. 2020 Jul;40(8):778-787. doi: 10.1177/0333102420906843. Epub 2020 Feb 14.
The International Headache Society (IHS) has published four editions of in the past 28 years. This continuous update process has been driven by the increasing amount of scientific data in the field of migraine and by the need to continuously improve the quality of trials.
To illustrate: i) the results of the analysis on the adherence of published trials to the 3rd edition published in 2012, in order to identify the critical areas that needed to be addressed in the 4th edition and ii) the changes introduced in this latter edition for improving adherence and methodology robustness.
We searched and reviewed all controlled trials on acute treatment of migraine published in the period 2012-2018 and we assessed their adherence to the 3rd edition of the IHS using a score system based on the most important recommendations. Afterwards, we compared the two editions of the and assessed the changes between them.
We included data from 24 controlled clinical trials. Most trials had a randomized double-blind controlled (RDB) design, while a minority (16.7%) were non-randomized double-blind trials. Less than half (44.6%) of the RDB trials used the recommended "pain-free at 2 hours" endpoint as the primary efficacy measure. Trial design and evaluation of results were the areas that diverged the most from the recommendations.
Adherence to IHS guidelines for clinical trials has been suboptimal so far. The new edition has been adapted and optimized to facilitate uptake and strengthen the quality of evidence.
国际头痛学会（IHS）在过去的 28 年中已经出版了四版。这种持续更新的过程是由偏头痛领域科学数据的不断增加以及不断提高试验质量的需要所驱动的。
说明：i）分析 2012 年出版的第 3 版对已发表试验的依从性的结果，以确定第 4 版需要解决的关键领域；ii）为提高依从性和方法学稳健性而在后者中引入的变化。
我们搜索并审查了 2012-2018 年期间发表的所有关于偏头痛急性治疗的对照试验，并使用基于最重要建议的评分系统评估它们对 IHS 第 3 版的依从性。之后，我们比较了两个版本的，并评估了它们之间的变化。
我们纳入了 24 项对照临床试验的数据。大多数试验采用随机双盲对照（RDB）设计，而少数（16.7%）是非随机双盲试验。不到一半（44.6%）的 RDB 试验将推荐的“2 小时无疼痛”终点作为主要疗效测量。试验设计和结果评估是与建议分歧最大的领域。
迄今为止，对 IHS 临床试验指南的依从性一直不理想。新版本进行了调整和优化，以促进采用并加强证据质量。
