@Article{duepublico_mods_00078453, author = {Tfelt-Hansen, Peer and Diener, Hans-Christoph}, title = {Pain freedom after 2 hours should be the primary outcome in controlled trials treating migraine attacks}, year = {2020}, month = {Jul}, day = {13}, keywords = {controlled trials; headache relief; Migraine attack; pain freedom; treatment}, abstract = {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.}, note = {<p>Tfelt-Hansen P, Diener H-C. Pain freedom after 2 hours should be the primary outcome in controlled trials treating migraine attacks. <em>Cephalalgia</em>. 2020;40(12):1331-1335. doi:<a href="https://doi.org/10.1177/0333102420941827">10.1177/0333102420941827</a></p> <p>First published online July 13, 2020</p>}, note = {Version of Record / Verlagsversion}, note = {Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-gef{\"o}rderten) Allianz- bzw. Nationallizenz frei zug{\"a}nglich. <hr />This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.}, note = {<p>OA Agreement: Deutsches Nationalkonsortium: Sage Journals Online Publish {\&}amp;{\&}{\#}xa0; Read. Zweitver{\"o}ffentlichung Version "Verlags-PDF" durch "Autor und Institution" erlaubt. Embargofrist: 12 Monate.</p> <p>OA-Rechte lt. EZB: https://ezb.ur.de/api/oa{\_}rights?bibid=UGHE{\&}amp;issn=0333-1024{\&}amp;year=2020{\&}amp;format=application/json</p> <p>Stand der Information 26.05.2023</p>}, doi = {10.1177/0333102420941827}, url = {https://duepublico2.uni-due.de/receive/duepublico_mods_00078453}, url = {https://doi.org/10.1177/0333102420941827}, file = {:https://duepublico2.uni-due.de/servlets/MCRFileNodeServlet/duepublico_derivate_00078064/Cephalalgia_2020_40_1331-1335.pdf:PDF}, language = {en} }