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Efficacy of nonprescription doses of ibuprofen for treating migraine headache. a randomized controlled trial.
Headache 2001 Jul-Aug; 41(7):665-79H

Abstract

OBJECTIVE

To evaluate the efficacy and safety of ibuprofen, 200 mg and 400 mg, compared with placebo and each other for the treatment of pain of migraine headache.

BACKGROUND

Migraine headache is a common illness with significant social and economic impact.

DESIGN

Randomized, placebo-controlled, double-blind trial of 6 hours' treatment duration.

METHODS

Fifteen investigators at 17 private practice and referral centers in the United States participated in this study of 660 outpatient adults aged 18 to 84 years with migraine headache of moderate to severe intensity. Each patient was randomly assigned to a single dose of study medication: ibuprofen 200 mg (n = 216) or 400 mg (n = 223), or placebo (n = 221). The percentage of patients with a reduction in baseline headache intensity from severe or moderate to mild or none 2 hours after treatment and the headache pain intensity difference from baseline at 2 hours were the primary efficacy measures. Secondary outcomes included other measures of pain relief, severity differences from baseline for migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability, and percentage of patients with migraine-associated symptoms reduced to none.

RESULTS

Significantly (P < or = .006) more patients treated with ibuprofen, 200 mg or 400 mg, reported mild to no pain after 2 hours (41.7% and 40.8%, respectively), compared with those treated with placebo (28.1%). The mean pain intensity difference from baseline measured at 2 hours was significantly (P < or = .001) greater for patients treated with ibuprofen 200 mg or 400 mg (0.68 and 0.65, respectively), compared with those treated with placebo (0.39). Statistically significant differences in favor of both doses of ibuprofen over placebo were observed for mean pain intensity difference at 1 hour after treatment. In patients with severe baseline pain intensity, ibuprofen, 400 mg, was significantly (P < or = .048) superior to placebo for the primary efficacy end points, while ibuprofen, 200 mg, was not. Ibuprofen, 200 mg and 400 mg, were statistically significantly more effective than placebo for all clinically important secondary pain relief outcomes. Mean severity changes of migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability at 2 and 6 hours were significantly (P < or = .03) in favor of both doses of ibuprofen over placebo, and results for the percentage of patients with symptoms reduced to none consistently, although less often statistically significant, favored ibuprofen. No statistically significant differences in adverse events were found among treatment groups.

CONCLUSIONS

Ibuprofen at doses of 200 mg and 400 mg is an efficacious, cost-effective, well-tolerated, single-ingredient nonprescription treatment for pain of migraine headache. In addition, while not always statistically significant, ibuprofen provided a beneficial effect on associated symptoms of migraine including nausea, photophobia, phonophobia, and functional disability.

Authors+Show Affiliations

Medical Department, McNeil Consumer Healthcare, Fort Washington, PA 19034, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11554954

Citation

Codispoti, J R., et al. "Efficacy of Nonprescription Doses of Ibuprofen for Treating Migraine Headache. a Randomized Controlled Trial." Headache, vol. 41, no. 7, 2001, pp. 665-79.
Codispoti JR, Prior MJ, Fu M, et al. Efficacy of nonprescription doses of ibuprofen for treating migraine headache. a randomized controlled trial. Headache. 2001;41(7):665-79.
Codispoti, J. R., Prior, M. J., Fu, M., Harte, C. M., & Nelson, E. B. (2001). Efficacy of nonprescription doses of ibuprofen for treating migraine headache. a randomized controlled trial. Headache, 41(7), pp. 665-79.
Codispoti JR, et al. Efficacy of Nonprescription Doses of Ibuprofen for Treating Migraine Headache. a Randomized Controlled Trial. Headache. 2001;41(7):665-79. PubMed PMID: 11554954.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of nonprescription doses of ibuprofen for treating migraine headache. a randomized controlled trial. AU - Codispoti,J R, AU - Prior,M J, AU - Fu,M, AU - Harte,C M, AU - Nelson,E B, PY - 2001/9/14/pubmed PY - 2001/10/5/medline PY - 2001/9/14/entrez SP - 665 EP - 79 JF - Headache JO - Headache VL - 41 IS - 7 N2 - OBJECTIVE: To evaluate the efficacy and safety of ibuprofen, 200 mg and 400 mg, compared with placebo and each other for the treatment of pain of migraine headache. BACKGROUND: Migraine headache is a common illness with significant social and economic impact. DESIGN: Randomized, placebo-controlled, double-blind trial of 6 hours' treatment duration. METHODS: Fifteen investigators at 17 private practice and referral centers in the United States participated in this study of 660 outpatient adults aged 18 to 84 years with migraine headache of moderate to severe intensity. Each patient was randomly assigned to a single dose of study medication: ibuprofen 200 mg (n = 216) or 400 mg (n = 223), or placebo (n = 221). The percentage of patients with a reduction in baseline headache intensity from severe or moderate to mild or none 2 hours after treatment and the headache pain intensity difference from baseline at 2 hours were the primary efficacy measures. Secondary outcomes included other measures of pain relief, severity differences from baseline for migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability, and percentage of patients with migraine-associated symptoms reduced to none. RESULTS: Significantly (P < or = .006) more patients treated with ibuprofen, 200 mg or 400 mg, reported mild to no pain after 2 hours (41.7% and 40.8%, respectively), compared with those treated with placebo (28.1%). The mean pain intensity difference from baseline measured at 2 hours was significantly (P < or = .001) greater for patients treated with ibuprofen 200 mg or 400 mg (0.68 and 0.65, respectively), compared with those treated with placebo (0.39). Statistically significant differences in favor of both doses of ibuprofen over placebo were observed for mean pain intensity difference at 1 hour after treatment. In patients with severe baseline pain intensity, ibuprofen, 400 mg, was significantly (P < or = .048) superior to placebo for the primary efficacy end points, while ibuprofen, 200 mg, was not. Ibuprofen, 200 mg and 400 mg, were statistically significantly more effective than placebo for all clinically important secondary pain relief outcomes. Mean severity changes of migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability at 2 and 6 hours were significantly (P < or = .03) in favor of both doses of ibuprofen over placebo, and results for the percentage of patients with symptoms reduced to none consistently, although less often statistically significant, favored ibuprofen. No statistically significant differences in adverse events were found among treatment groups. CONCLUSIONS: Ibuprofen at doses of 200 mg and 400 mg is an efficacious, cost-effective, well-tolerated, single-ingredient nonprescription treatment for pain of migraine headache. In addition, while not always statistically significant, ibuprofen provided a beneficial effect on associated symptoms of migraine including nausea, photophobia, phonophobia, and functional disability. SN - 0017-8748 UR - https://www.unboundmedicine.com/medline/citation/11554954/Efficacy_of_nonprescription_doses_of_ibuprofen_for_treating_migraine_headache__a_randomized_controlled_trial_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=0017-8748&amp;date=2001&amp;volume=41&amp;issue=7&amp;spage=665 DB - PRIME DP - Unbound Medicine ER -