Shorter Placebo Regimen May Improve Menstrual Migraines

October 12, 2011

According to some estimates, menstrual migraine effect about 60% to 70% of women. Since hormone levels might impact these migraines, Dr Vincent De Leo from the department of obstetrics and gynecology at the University of Siena in Italy, and colleagues sought to examine the impact of two different oral contraception regimens on the migraines.

According to some estimates, menstrual migraine effect about 60% to 70% of women. Since hormone levels might impact these migraines, Dr Vincent De Leo from the department of obstetrics and gynecology at the University of Siena in Italy, and colleagues sought to examine the impact of two different oral contraception regimens on the migraines.

De Leo and colleagues conducted a prospective randomized study of women ages 20 through 35 years of age (N=60). Participants presented at the gynecology department of the University of Siena to receive consultation regarding the most appropriate contraception. All of the women suffered from pure menstrual migraine without aura. The women were randomized to one of two groups for three months; group one received 21 active plus the standard 7 placebo oral contraceptive pills and group two received 24 active oral contraceptive pills  plus 4 placebo pills.  All of the active pills contained 20 μg of ethinyl E2 and 3 mg of drospirenone. Women in each group rated their headache intensity.

At the study onset, both groups rated their headache intensity at about 2.75 on a scale of 0 to 3. On average, both groups had three days with migraines. At the conclusion of the study, De Leo and colleagues found that both groups reported significantly less intense migraines and shorter duration of menstrual migraines. However, the group receiving only 4 placebo pills reported a greater reduction in duration and intensity as compared to those in the group receiving 7 placebo pills. Specifically, at month 3, the 24/4 group rated their pain at an average of about a 1 while the 21/7 group’s average pain rating was 1.4. Similarly, women in the group receiving 4 placebo pills had an average of one day of migraine during month 3 while the women taking 7 placebo pills had an average of 1.4 days of migraine during month 3. De Leo and colleagues noted that adherence was excellent and that none of the patients reported side effects.

Based on their findings, De Leo et al. concluded, “The use of a 24/4 regimen, with a shortened 4-day pill-free interval, and with a progestin such as drospirenone, should be the regimen of choice for women suffering from menstrual migraines.”

According to the International Headache Society, menstrual migraines have two subtypes. Menstrually related migraine without aura has onset during the peri-menstrual time period during at least two-thirds of the menstrual cycles; in this subtype, migraines may also occur at other times during the menstrual cycle. On the other hand, pure menstrual migraine without aura only occur only during the peri-menstrual time period (eg, not during any other time of the menstrual cycle). While multiple factors may play a role in its pathophysiology, the decline of serum estradiol levels is considered the most plausible trigger. Currently, there are several acute therapies and short- and long-term prophylactic therapies to treat menstrual migraines.  Oral contraceptives are considered a continuous prophylactic treatment approach.

References:

References:/
De Leo V, Scolaro V, Musacchio MC, et al. Combined oral contraceptives in women with menstrual migraine without aura. Fertil Steril. 2011; 96(4):917-20.
24/4 combined oral contraceptives best for pure menstrual migraine. Reuters Health Information. September 27, 2011.
Martin VT. Menstrual Migraine: New Approaches to Diagnosis and Treatment. American Headache Society. http://www.americanheadachesociety.org/assets/MartinMigriane.pdf. Accessed Oct. 9.