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

Joseph Sargent, Patricia Solbach, Hanna Damasio, Barry Baumel, James Corbett, Larry Eisner, Barbara Jessen, Lee Kudrow, Ninan Mathew, Jose Medina, Joel Saper, Nazhiyath Vijayan, Craig Watson, Jeanne Alger

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)320-324
Number of pages5
JournalHeadache: The Journal of Head and Face Pain
Volume25
Issue number6
DOIs
StatePublished - 1985
Externally publishedYes

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Naproxen
Migraine Disorders
Propranolol
Placebos
Headache
Menstruation
Research Personnel
Nausea
Migraine without Aura
A 17
Therapeutics
Migraine with Aura
Matched-Pair Analysis
Incidence
Multicenter Studies
Vomiting

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

A Comparison of Naproxen Sodium to Propranolol Hydrochloride and a Placebo Control for the Prophylaxis of Migraine Headache. / Sargent, Joseph; Solbach, Patricia; Damasio, Hanna; Baumel, Barry; Corbett, James; Eisner, Larry; Jessen, Barbara; Kudrow, Lee; Mathew, Ninan; Medina, Jose; Saper, Joel; Vijayan, Nazhiyath; Watson, Craig; Alger, Jeanne.

In: Headache: The Journal of Head and Face Pain, Vol. 25, No. 6, 1985, p. 320-324.

Research output: Contribution to journalArticle

Sargent, J, Solbach, P, Damasio, H, Baumel, B, Corbett, J, Eisner, L, Jessen, B, Kudrow, L, Mathew, N, Medina, J, Saper, J, Vijayan, N, Watson, C & Alger, J 1985, 'A Comparison of Naproxen Sodium to Propranolol Hydrochloride and a Placebo Control for the Prophylaxis of Migraine Headache', Headache: The Journal of Head and Face Pain, vol. 25, no. 6, pp. 320-324. https://doi.org/10.1111/j.1526-4610.1985.hed2506320.x
Sargent, Joseph ; Solbach, Patricia ; Damasio, Hanna ; Baumel, Barry ; Corbett, James ; Eisner, Larry ; Jessen, Barbara ; Kudrow, Lee ; Mathew, Ninan ; Medina, Jose ; Saper, Joel ; Vijayan, Nazhiyath ; Watson, Craig ; Alger, Jeanne. / A Comparison of Naproxen Sodium to Propranolol Hydrochloride and a Placebo Control for the Prophylaxis of Migraine Headache. In: Headache: The Journal of Head and Face Pain. 1985 ; Vol. 25, No. 6. pp. 320-324.
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abstract = "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.",
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AU - Corbett, James

AU - Eisner, Larry

AU - Jessen, Barbara

AU - Kudrow, Lee

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AB - 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.

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