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Rofecoxib versus ibuprofen for acute treatment of migraine: a randomised placebo controlled trial.

Abstract

BACKGROUND

Rofecoxib is a potent cyclo-oxygenase-2 inhibitor with a long duration of action. Its role in migraine has not been systematically evaluated.

AIM

To study the efficacy of rofecoxib in migraine.

METHOD

In a randomised placebo controlled trial rofecoxib 25 mg, ibuprofen 400 mg, and placebo were compared regarding their efficacy in relieving acute migraine attack. Migraine patients with 2-6 attacks per month were recruited. Headache severity, functional disability, and severity of associated symptoms were graded on a 0-3 scale. The primary endpoint was pain relief at two hours. Relief of associated symptoms and sustained pain relief for 24 hours were also noted.

RESULT

One hundred and twenty four patients were randomised into rofecoxib (42), ibuprofen (40), and placebo (42) groups. One hundred and one patients were followed up: 33 on rofecoxib, 35 ibuprofen, and 33 placebo. Patients' ages ranged from 16-62 (mean 31.4) years, and 83 were females. Pain relief at two hours was noted in 45.5% on rofecoxib, 55.6% on ibuprofen, and 9.1% in the placebo group. The associated symptoms at two hours were reduced in 39.4% on rofecoxib, 50% on ibuprofen, and 9.1% in the placebo group. Sustained 24 hour pain relief was noted in 36.4% on rofecoxib, 41% on ibuprofen, and 6.1% in the placebo group. In the ibuprofen group, five patients had abdominal pain but there were no side effects in those on rofecoxib or in the control group. Both rofecoxib and ibuprofen were significantly effective in relieving pain, associated symptoms at two hours, and in sustained pain relief. There was no significant difference between rofecoxib and ibuprofen in aborting acute migraine attacks.

CONCLUSIONS

Both ibuprofen and rofecoxib were superior to placebo in aborting an acute migraine attack, and there was no significant difference in their efficacy in an acute migraine attack.

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  • Authors+Show Affiliations

    ,

    Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India. ukmisra@sgpgi.ac.in

    ,

    Source

    Postgraduate medical journal 80:950 2004 Dec pg 720-3

    MeSH

    Acute Disease
    Adolescent
    Adult
    Analgesics, Non-Narcotic
    Anti-Inflammatory Agents, Non-Steroidal
    Double-Blind Method
    Female
    Humans
    Ibuprofen
    Lactones
    Male
    Middle Aged
    Migraine Disorders
    Sulfones
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    15579612

    Citation

    Misra, U K., et al. "Rofecoxib Versus Ibuprofen for Acute Treatment of Migraine: a Randomised Placebo Controlled Trial." Postgraduate Medical Journal, vol. 80, no. 950, 2004, pp. 720-3.
    Misra UK, Jose M, Kalita J. Rofecoxib versus ibuprofen for acute treatment of migraine: a randomised placebo controlled trial. Postgrad Med J. 2004;80(950):720-3.
    Misra, U. K., Jose, M., & Kalita, J. (2004). Rofecoxib versus ibuprofen for acute treatment of migraine: a randomised placebo controlled trial. Postgraduate Medical Journal, 80(950), pp. 720-3.
    Misra UK, Jose M, Kalita J. Rofecoxib Versus Ibuprofen for Acute Treatment of Migraine: a Randomised Placebo Controlled Trial. Postgrad Med J. 2004;80(950):720-3. PubMed PMID: 15579612.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Rofecoxib versus ibuprofen for acute treatment of migraine: a randomised placebo controlled trial. AU - Misra,U K, AU - Jose,M, AU - Kalita,J, PY - 2004/12/8/pubmed PY - 2005/4/1/medline PY - 2004/12/8/entrez SP - 720 EP - 3 JF - Postgraduate medical journal JO - Postgrad Med J VL - 80 IS - 950 N2 - BACKGROUND: Rofecoxib is a potent cyclo-oxygenase-2 inhibitor with a long duration of action. Its role in migraine has not been systematically evaluated. AIM: To study the efficacy of rofecoxib in migraine. METHOD: In a randomised placebo controlled trial rofecoxib 25 mg, ibuprofen 400 mg, and placebo were compared regarding their efficacy in relieving acute migraine attack. Migraine patients with 2-6 attacks per month were recruited. Headache severity, functional disability, and severity of associated symptoms were graded on a 0-3 scale. The primary endpoint was pain relief at two hours. Relief of associated symptoms and sustained pain relief for 24 hours were also noted. RESULT: One hundred and twenty four patients were randomised into rofecoxib (42), ibuprofen (40), and placebo (42) groups. One hundred and one patients were followed up: 33 on rofecoxib, 35 ibuprofen, and 33 placebo. Patients' ages ranged from 16-62 (mean 31.4) years, and 83 were females. Pain relief at two hours was noted in 45.5% on rofecoxib, 55.6% on ibuprofen, and 9.1% in the placebo group. The associated symptoms at two hours were reduced in 39.4% on rofecoxib, 50% on ibuprofen, and 9.1% in the placebo group. Sustained 24 hour pain relief was noted in 36.4% on rofecoxib, 41% on ibuprofen, and 6.1% in the placebo group. In the ibuprofen group, five patients had abdominal pain but there were no side effects in those on rofecoxib or in the control group. Both rofecoxib and ibuprofen were significantly effective in relieving pain, associated symptoms at two hours, and in sustained pain relief. There was no significant difference between rofecoxib and ibuprofen in aborting acute migraine attacks. CONCLUSIONS: Both ibuprofen and rofecoxib were superior to placebo in aborting an acute migraine attack, and there was no significant difference in their efficacy in an acute migraine attack. SN - 0032-5473 UR - https://www.unboundmedicine.com/medline/citation/15579612/Rofecoxib_versus_ibuprofen_for_acute_treatment_of_migraine:_a_randomised_placebo_controlled_trial_ L2 - http://pmj.bmj.com/cgi/pmidlookup?view=long&pmid=15579612 DB - PRIME DP - Unbound Medicine ER -