{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T11:58:43Z","timestamp":1770983923664,"version":"3.50.1"},"reference-count":59,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2013,11,1]],"date-time":"2013-11-01T00:00:00Z","timestamp":1383264000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Headache"],"published-print":{"date-parts":[[2014,1]]},"abstract":"\n Objective<\/jats:title>\n \n This study was performed to evaluate the efficacy and safety of the combination of sumatriptan (50\u2009mg) plus promethazine (\n SPr<\/jats:styled-content>\n ) (25\u2009mg) compared with sumatriptan (50\u2009mg) plus placebo in patients with migraine attacks.\n <\/jats:p>\n <\/jats:sec>\n \n Background<\/jats:title>\n Migraine is a chronic, disabling disorder with an estimated worldwide prevalence of 10% in adults imposing substantial social and economic impact. Efficient treatment of migraine attacks could benefit patients by reducing their disability and the need for health care resources, and improving economic productivity.<\/jats:p>\n <\/jats:sec>\n \n Design and Methods<\/jats:title>\n \n This was a multicenter, randomized, double\u2010blind trial conducted at 5 university\u2010affiliated research centers in\n I<\/jats:styled-content>\n ran. Between\n J<\/jats:styled-content>\n anuary 2013 and\n A<\/jats:styled-content>\n pril 2013, 350 individuals with a history of migraine were evaluated. Patients were diagnosed with migraine, with or without aura, as defined by the International\n H<\/jats:styled-content>\n eadache\n S<\/jats:styled-content>\n ociety diagnostic criteria. The 242 patients meeting the eligibility criteria were randomly assigned to\n SPr<\/jats:styled-content>\n group (n\u2009=\u2009121) or the sumatriptan plus placebo (\n SP<\/jats:styled-content>\n ) group (n\u2009=\u2009121). The study medications were taken on an outpatient basis during the moderate to severe phase of migraine attack. Patients recorded details of the treated migraine on a diary card and rated pain severity immediately before dosing and 30 minutes, 1 hour, 2 hours, and 4 hours after dosing using a 4\u2010point scale (0\u2009=\u2009none to 3\u2009=\u2009severe).\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 242 patients randomized, 216 were included in the intention\u2010to\u2010treat efficacy analysis. In the\n SPr<\/jats:styled-content>\n group, 39.6% of subjects experienced 2\u2010hour headache\u2010free response (primary outcome), which was significantly more effective than\n SP<\/jats:styled-content>\n treatment (26.3%, odds ratio: 1.83, 95% confidence interval: 1.03\u20133.26,\n P<\/jats:italic>\n \u2009=\u2009.038). Significantly more patients receiving\n SPr<\/jats:styled-content>\n treatment (62.2%) had headache improvement compared with\n SP<\/jats:styled-content>\n treatment (37.2%) at 2 hours (odds ratio: 2.77, 95% confidence interval: 1.60\u20104.81,\n P<\/jats:italic>\n \u2009<\u2009.001). A similar pattern of between\u2010group differences was observed for 4\u2010hour headache\u2010free response (\n P<\/jats:italic>\n \u2009=\u2009.006) and headache improvement response (\n P<\/jats:italic>\n \u2009=\u2009.003). The incidence of headache recurrence within 2\u201048 hours after treatment was lowest in the\n SPr<\/jats:styled-content>\n group (15.0%) compared with\n SP<\/jats:styled-content>\n group (26.6%,\n P<\/jats:italic>\n \u2009=\u2009.041).\n <\/jats:p>\n \n The only significant drug\u2010related adverse events reported in \u226515% of patients in any treatment group were somnolence (32.2% and 7% in the\n SPr<\/jats:styled-content>\n and\n SP<\/jats:styled-content>\n groups, respectively,\n P<\/jats:italic>\n \u2009<\u2009.001), extrapyramidal symptoms (4.3% and 0%,\n P<\/jats:italic>\n \u2009=\u2009.05), and nausea (1% and 8%,\n P<\/jats:italic>\n \u2009=\u2009.03).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n This is the first prospective clinical trial to demonstrate that multimechanism therapy for migraine, combining a triptan and an antiemetic agent, is well tolerated and offers improved clinical benefits compared with monotherapy.<\/jats:p>\n 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