Rofecoxib in the prevention of perimenstrual migraine: an open-label pilot trial
Abstract
OBJECTIVE: To investigate the effectiveness of rofecoxib in the prevention of perimenstrual migraine.
BACKGROUND: Nonsteroidal anti-inflammatory drugs have demonstrated benefit in reducing the frequency and intensity of menstrual migraine when administered perimenstrually. Anti-inflammatory drugs, however, may not be well tolerated and can produce gastrointestinal irritation. Rofecoxib, a selective cyclooxygenase-2 inhibitor, has anti-inflammatory and analgesic properties, and a significantly improved gastrointestinal tolerability profile.
METHODS: A pilot study was conducted in which patients with a history of menstrually associated migraine and experiencing at least one migraine monthly during the perimenstrual period were enrolled. Patients who completed a baseline diary for the first month were randomized to receive either rofecoxib 25 mg or 50 mg daily for 10 days, starting 5 days before menstrual flow. Headaches experienced during this 10-day period were recorded in the patient's diary. Patients continued rofecoxib for 2 consecutive menstrual cycles. Mean migraine frequency, intensity, and duration as well as patient's level of functioning during the 2 cycles were compared with baseline.
RESULTS: Fourteen patients completed baseline and rofecoxib dosing for 2 menstrual cycles. Mean migraine frequency decreased from 5.6 to 2.6 migraines per menstrual cycle (P=.005). Eight (57%) of 14 patients had a > or = 50% reduction in headache frequency. No significant improvement…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 14 participants or records.
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