M P Solbach1, R S Waymer. 1. U.S. Sumatriptan Research Group, Menninger Clinic, Topeka, KS.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of sumatriptan, a 5-HT1 receptor agonist, in patients with menstruation-associated migraine. METHODS: Two double-blind, placebo-controlled, single-attack parallel group studies of subcutaneous sumatriptan were conducted for the acute treatment of migraine. A retrospective analysis of 1104 patients produced 157 women who were treated for a menstruation-associated migraine (defined as a migraine beginning between 1 day before and 4 days after the onset of menstrual flow) and 512 women treated for nonmenstrual migraine. We excluded 435 other patients who were either male (123), women with hysterectomies (260), or women with missing data (52). Patients with moderate or severe pain were treated with 6 mg subcutaneous sumatriptan or placebo. One hour after treatment, response rates of headache severity and associated symptoms were measured. Menstruation-associated migraine patients were compared to female patients with nonmenstrual migraine. Migraine recurrence was analyzed retrospectively for 24 hours. RESULTS: At 1 hour, 80% of the sumatriptan-treated menstrual-migraine patients had pain relief (reduction of severe or moderate pain to mild or no pain), compared to 19% of the placebo patients (P < .001). Sumatriptan also treated nausea and photophobia more effectively in menstrual-migraine patients than did placebo. Response rates for pain and associated symptoms were similar between patients with menstruation-associated and nonmenstrual migraines. Adverse effects were also similar between the groups. CONCLUSION:Sumatriptan was as effective and well tolerated for menstruation-associated migraine as it was for nonmenstrual migraine.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of sumatriptan, a 5-HT1 receptor agonist, in patients with menstruation-associated migraine. METHODS: Two double-blind, placebo-controlled, single-attack parallel group studies of subcutaneous sumatriptan were conducted for the acute treatment of migraine. A retrospective analysis of 1104 patients produced 157 women who were treated for a menstruation-associated migraine (defined as a migraine beginning between 1 day before and 4 days after the onset of menstrual flow) and 512 women treated for nonmenstrual migraine. We excluded 435 other patients who were either male (123), women with hysterectomies (260), or women with missing data (52). Patients with moderate or severe pain were treated with 6 mg subcutaneous sumatriptan or placebo. One hour after treatment, response rates of headache severity and associated symptoms were measured. Menstruation-associated migrainepatients were compared to female patients with nonmenstrual migraine. Migraine recurrence was analyzed retrospectively for 24 hours. RESULTS: At 1 hour, 80% of the sumatriptan-treated menstrual-migrainepatients had pain relief (reduction of severe or moderate pain to mild or no pain), compared to 19% of the placebo patients (P < .001). Sumatriptan also treated nausea and photophobia more effectively in menstrual-migrainepatients than did placebo. Response rates for pain and associated symptoms were similar between patients with menstruation-associated and nonmenstrual migraines. Adverse effects were also similar between the groups. CONCLUSION:Sumatriptan was as effective and well tolerated for menstruation-associated migraine as it was for nonmenstrual migraine.