25 General introduction 1 Hormonal treatment specific for menstrual migraine Considering the oestrogen withdrawal theory, some small studies suggest that continuous estradiol supplementation might benefit women with migraine.58-60 For instance, a small double-blind placebo-controlled crossover study reported a 22% reduction in migraine frequency with daily estradiol (1·5 mg) administration.61 However, there was a 40% increase in migraine frequency observed five days after stopping the intervention, indicating that while migraine attacks can be delayed by preventing the oestrogen drop before menstruation, they may not be entirely prevented. Combined oral contraceptive pills are frequently prescribed as preventive treatment for migraine in women, even though there is no evidence of its effectiveness to date. These pills typically contain an oestrogen (typically ethinylestradiol) and a progestogen (typically progestin) to prevent pregnancy. Combined oral contraceptives come in various hormone doses and regimes, with the 21/7 regimen – 21 days of pill administration followed by a seven-day hormone-free interval – being the most common. However, evidence supporting their efficacy for migraine prevention is lacking, and their usage may be associated with side effects.62, 63 Hence, there is a strong need for clarity on the potential role of combined oral contraceptives in the prevention of migraine. Studies have investigated strategies such as shortening or eliminating the hormonalfree-interval or adding oestrogen supplementation during this period to prevent perimenstrual migraine attacks.26, 64 Shortening the hormonal-free-interval has shown promise in reducing migraine intensity and frequency in some studies, but exacerbation of symptoms has also been reported in others.59, 65 Extended regimens (without a hormone-free interval) are suggested to be more effective than traditional 21/7 regimen in terms of reducing migraine days and medication intake.57, 66 It is advised not to prescribe combined oral contraceptive pills to women with migraine with aura or women with migraine without aura with additional cardiovascular risk factors because this further increases the risk of cardiovascular diseases. Administration of progesterone alone, such as with the mini-pill or a hormonal intrauterine device, is considered safer from a cardiovascular perspective. However, the fact remains that the effect on migraine has not been sufficiently studied.64 A pragmatic trial is being conducted in the Netherlands (the WHAT study). This is the first large randomized trial studying the effect of continuous combined oral contraceptive pill as a preventive treatment for menstrual migraine.
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