A Comparison of Naproxen Sodium to Propranolol Hydrochloride and a Placebo Control for the Prophylaxis of Migraine Headache

SYNOPSIS A 17 week, double‐blind, randomized, parallel, multicenter study compared naproxen sodium 550 mg bid, propranolol hydrochloride 40 mg tid, and placebo in 129 patients with classical or common migraine. Daily efficacy data were collected during the 12 week full treatment phase. Characteristics measured included headache days, headache severity, nausea, vomiting and visual disturbances. Patients and investigators, separately, rated the overall response and tolerance to the medication at the end of the trial. Patients' daily records revealed a trend toward superiority in the reduction of headache frequency, headache severity, nausea and visual disturbances for naproxen sodium and propranolol hydrochloride when compared to the placebo. In the overall evaluation of therapeutic response, both patients and investigators favored naproxen sodium in comparison with placebo. In a similar paired comparison the patients, but not the investigators, judged the overall response to propranolol better than placebo. In the overall evaluation of tolerance, both the patients and investigators favored propranolol hydrochloride. The majority of patients reported a high incidence and severity of gastrointestinal complaints associated with naproxen sodium treatment than propranolol hydrochloride treatment. The incidence and severity of nongastrointestinal complaints related to naproxen and propranolol hydrochloride treatment were comparable. Headache activity occurring before and after the onset of menses was analyzed for a subset of 30 patients. Those treated with naproxen sodium experienced lesser headache frequency and severity during the week prior to menses, compared with the week after onset of menses. The difference in severity in the naproxen sodium treated patients was statistically significant when compared to the placebo treated patients and approached significance when compared to the propranolol hydrochloride treated patients. In this study naproxen sodium was shown to be an effective prophylactic medication for migraine. A long‐term study, to confirm these findings, seems warranted.