Effect of a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG) in women with menstrually-related migraine (MRM)

BACKGROUND: Combined hormonal contraception might worsen migraine in sensitive women especially during the free-hormone interval and raise concerns about the vascular risk. The characteristics of a contraceptive pill containing estradiol valerate/dienogest (E2V/DNG) might be of potential benefit in women with menstrually related migraine (MRM) who choose to use oral contraception for birth control. STUDY DESIGN: This was a prospective diary-based pilot study. Thirty-two women (age >35 years) [n=18 who had never used combined oral contraceptives (COCs) and n=14 who had previously used COCs] diagnosed with MRMs according to the International Headache Society criteria were included. During the observational period women filled in a diary with the clinical characteristics of migraine attacks. After a three-cycle run-in period each subject received a COC containing E2V/DNG (Qlaira(R)/Natazia(R); Bayer HealthCare Berlin Germany) administered using an estrogen step-down and progestogen step-up approach. Follow-up evaluations were scheduled at the last cycle of run-in and at the third and sixth cycles of treatment. RESULTS: The number of migraine attacks was significantly reduced at the third (p<.001) and sixth cycles (p<.001) in comparison with the run-in period. A similar result was evident for the duration (p<.001 at the third and p<.001 at the sixth cycle) as well as for the severity of head pain (p<.001 at the third and p<.001 at the sixth month). Indeed a significantly lower number of analgesics were used at the third cycle (p<.001) in comparison with baseline and a further decrease was evident at the sixth cycle (p<.001) in comparison with the third cycle of E2V/DNG use. Interestingly duration and severity of head pain were significantly correlated with the number of days of dysmenorrhea at the third cycle (r=.89 p=.000 and r=.67 p=.02; respectively) and at the sixth cycle (r=.76 p=.000 and r=.62 p=.04; respectively) in women without complete remission of menstrual cramps during the study period. CONCLUSIONS: The present diary-based pilot study indicates that the use of a pill containing EV2/DNG for six cycles has a positive effect in women with MRM and suggests an association between dysmenorrhea with COCs use as a potential feature of refractory head pain. Copyright (c) 2013 Elsevier Inc. All rights reserved.