Diagnosis of menstrual headache and an open-label study among those with previously undiagnosed menstrually related migraine to evaluate the efficacy of sumatriptan 100 mg

Abstract

Background: Headache associated with menses is often not formally diagnosed. Objectives: The goal of this study was to evaluate patients with menstrual headache who had never previously been diagnosed with migraine and assign 1988 International Headache Society (IHS) diagnoses to their menstrual headaches. Secondary objectives included evaluation of the treatment efficacy of newly diagnosed menstrually related migraine (MRM) with sumatriptan 100 mg and patient satisfaction with sumatriptan versus satisfaction with previous therapy. Methods: Patients were recruited via advertisement in a local daily newspaper, and headache diagnosis and eligibility criteria of respondents were assessed by telephone. During telephone screening, IHS criteria for headache were applied to symptoms described by patients as menstrual headache. Those with previously undiagnosed headaches who fulfilled criteria for migraine without or with aura (IHS 1.1 or 1.2) and all inclusion/exclusion criteria at visit 1 were provided with sumatriptan 100 mg to treat 1 MRM. Patients were instructed to treat their next MRM as early as possible after the onset of headache. A treatment diary was provided with study medication for documentation of headache pain severity and associated symptoms; time of treatment and response at 30, 60, and 90 minutes and at 2, 4, 24, and 48 hours posttreatment; medication for persistence or recurrence; adverse effects; and onset of menstrual cycle. In analysis, headache response was defined as a reduction in pretreatment head pain from moderate or severe to mild or no pain. Results: A total of 153 patients responded to an advertisement seeking menstrual headache sufferers. After the preliminary screening by telephone, 105 patients were assigned IHS diagnoses based on reported symptoms associated with their menstrual headache. Overall, 63% (66/105) fulfilled criteria for IHS 1.1 (migraine without aura), 12% (13/105) met criteria for IHS 1.2 (migraine with aura), and 5% (5/105) met criteria for IHS 1.7 (migrainous disorder). Of the 79 patients meeting the criteria for IHS 1.1 or 1.2, 45 patients were enrolled. Thirty-nine (mean age, 34.8 years; mean duration of experiencing menstrual headaches, 11.1 years) of the 45 patients treated 1 MRM with sumatriptan 100 mg per protocol (6 patients were lost to follow-up or withdrew consent). Headache response was reported by 70% of patients at 2 hours and 86% at 4 hours. The pain-flee response after treatment at the moderate or severe phase occurred in 41% of patients at 2 hours and in 61% at 4 hours. All 39 patients reported previous use of nonsteroidal anti-inflammatory medications for acute treatment of headache; in addition, 1 of the 39 also took acetylsalicylic acid/caffeine/butalbital, 1 took acetaminophen/caffeine/butalbital, 1 took ketorolac, and 1 took acetaminophen plus codeine. In terms of patient satisfaction, 69% of patients were satisfied with sumatriptan versus 15% of patients who were satisfied with their previous therapy. Conclusions: Seventy-five percent of women with previously undiagnosed menstrual headaches met diagnostic criteria for migraine in this small sample. Two hours after treatment with sumatriptan 100 rag, 70% of patients with headaches treated at moderate to severe pain had a pain relief response (reduction to mild or no pain).