Department of Neurology, Leiden University Medical Center, PO Box 9600, Leiden, 2300 RC, The Netherlands.
Division of Vascular Medicine and Pharmacology, Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.
Trials. 2024 Feb 15;25(1):123. doi: 10.1186/s13063-024-07955-8.
Currently, there is no evidence-based hormonal treatment for migraine in women. Several small studies suggest a beneficial effect of combined oral contraceptives, but no large randomized controlled trial has been performed. As proof of efficacy is lacking and usage may be accompanied by potentially severe side effects, there is a great need for clarity on this topic.
Women with menstrual migraine (n = 180) are randomly assigned (1:1) to ethinylestradiol/levonorgestrel 30/150 μg or vitamin E 400 IU. Participants start with a baseline period of 4 weeks, which is followed by a 12-week treatment period. During the study period, a E-headache diary will be used, which is time-locked and includes an automated algorithm differentiating headache and migraine days.
The primary outcome will be change in monthly migraine days (MMD) from baseline (weeks - 4 to 0) to the last 4 weeks of treatment (weeks 9 to 12). Secondary outcomes will be change in monthly headache days (MHD) and 50% responder rates of MMD and MHD.
The WHAT! trial aims to investigate effectivity and safety of continuous combined oral contraceptive treatment for menstrual migraine. Immediate implementation of results in clinical practice is possible.
Clinical trials.gov NCT04007874 . Registered 28 June 2019.
目前，针对女性偏头痛尚无基于循证医学的激素治疗方法。一些小型研究表明复方口服避孕药可能具有一定的疗效，但尚未开展大型随机对照试验。由于缺乏疗效证据，且使用可能伴有潜在严重的副作用，因此有必要对此问题进行澄清。
将 180 例月经性偏头痛女性患者随机（1:1）分配至乙炔雌二醇/左炔诺孕酮 30/150μg 组或维生素 E 400IU 组。所有参与者首先进行 4 周的基线期，随后进入 12 周的治疗期。研究期间，使用电子头痛日记，该日记具有时间锁定功能，包括区分头痛和偏头痛日的自动算法。
主要结局指标为从基线期（-4 周到 0 周）到治疗最后 4 周（9 周到 12 周）每月偏头痛天数（MMD）的变化。次要结局指标为每月头痛天数（MHD）和 MMD 和 MHD 中 50%缓解率的变化。
WHAT！试验旨在研究连续联合口服避孕药治疗月经性偏头痛的有效性和安全性。可立即将研究结果付诸临床实践。
Clinicaltrials.gov NCT04007874。2019 年 6 月 28 日注册。
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