137 Rationale and protocol of the WHAT! Trial 6 DISCUSSION This article presents the rationale and design of an ongoing randomized controlled trial that aims to investigate the preventive effect of continuous daily use of ethinylestradiol/levonorgestrel (30/150 μg/day) compared with vitamin E (400 IU/day) in women with menstrual migraine. Our trial is designed to provide evidence for the effectiveness of the combined oral contraceptive pill as a preventive treatment for menstrual migraine. Vitamin E is being used as a placebo control group in this trial. The choice of vitamin E as a placebo was based on its limited efficacy in the prevention of menstrual migraine attacks and its good tolerability profile.21 This will allow for a fair comparison between the two treatment groups while minimizing the risk of bias. To correct for the deblinded setting of the study, the Stanford Expectations of Treatment Scale will be used.29 This scale is designed to assess the expectations of participants regarding the effectiveness of the treatment they receive. By using this scale, we can measure and adjust for any potential differences in expectations between the two treatment groups, which could influence the outcomes of the trial. Menstrual migraine affects an important proportion of women of reproductive age, as it concerns two-thirds of all women with migraine.25 Despite the availability of prophylactic medications, many women still experience frequent attacks, particularly during the menstrual window.30 These perimenstrual attacks are often longer of duration with increased risk of recurrence, more severe and less responsive to acute medication.31 Previous studies have suggested that the use of combined oral contraceptives, such as ethinylestradiol/levonorgestrel, can reduce the frequency and severity of perimenstrual migraine attacks. However, the current evidence is limited and conflicting, and the optimal dosing regimen and duration of treatment remain unclear. Therefore, this large randomized controlled trial is an imperative necessity to determine the efficacy of the continuous use of ethinylestradiol/levonorgestrel in women with menstrual migraine. CONCLUSION The results of the WHAT!-trial will have important implications for the clinical management of women with menstrual migraine and can be implemented in future guidelines and recommendations regarding the use of combined oral contraceptive pills as a preventive treatment.
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