Table Isometheptene for acute migraine
Study Study Design Patients Drug groups & dosing regimes Outcomes Results Quality Score
Diamond and Medina 1975 RCT, DB, CO, 4 migraine attacks treated, each patient took each treatment twice, study med taken at migraine onset Migraine with or without aura diagnosed per Ad Hoc committee (pre-IHS criteria), at least 2 migraines per month, men and women, age 22 to 62, n=36 1. Isometheptene 2 tabs (130 mg) initially then 1 tab hourly as needed, max 6 tabs in 4 hours 2. Placebo Headache severity (1=none, 2=mild, 3=moderate, 4=severe) Pain relief (1=complete, 2=good, 3=fair, 4=poor) n=36 patients evaluated # patients reporting good or complete relief for all 4 migraine attacks: Isometheptene 30/72 (42%) Placebo 21/72 (29%) Headache severity significantly less in Isometheptene group than placebo (p=0.05) # patients reporting adverse e R=1 DB=1 W=0 Total=2
Diamond 1976 RCT, DB, CO, 6 migraine attacks treated, each patient took each treatment twice, study med taken at migraine onset Migraine with or without aura, DNS diagnostic criteria used, men and women, age 21 +, n=56 1. Midrin (isometheptene mucate 65 mg, dichloralphenazone 100 mg, paracetamol 325 mg) 2. Paracetamol 325 mg 3. Placebo 2 tabs taken initially, then 1 tab every hour if needed, max 5 tabs in 4 hours Headache severity (severe, moderate, mild, none) Headache relief (complete, good, fair, none) Physician global assessment Isometheptene gave significantly better pain relief than placebo (p<0.05), nsd on severity # patients with adverse effects: Isometheptene 14/56 with 19 AEs Paracetamol 10/56 with 12 AEs Placebo 1/56 with 2 AEs R=1 DB=1+1 W=0 Total=3
Ryan 1974 RCT, DB, CO,6 migraine attacks treated, each patient took each treatment twice, study med taken at migraine onset Migraine with or without aura, DNS diagnostic criteria used, men and women, age 22 to 77, n=60 1. Isometheptene mucate 2. Midrin (isometheptene mucate 65 mg, dichloralphenazone 100 mg, paracetamol 325 mg) 3. Placebo 2 tabs taken initially, then 1 tab every hour if needed, max 5 tabs in 4 hours Headache severity (1=mild, 2=moderate, 3=severe) Pain relief (3=complete, 2=good,1=fair,0=none) Physician global assessment and number of tablets taken # patients reporting good or complete relief for attacks 1 to 3: Isometheptene 23/63 (37%) Midrin 15/55 (27%) Placebo 13/41 (32%) # patients reporting good or complete relief for attacks 4 to 6: Isometheptene 18/61 (30%) Midrin 17/60 (28%) Placebo 11/39 ( R=1 DB=1 W=0 Total=2
Yuill et al 1972 RCT, DB, CO, 2 or more attacks treated, study med taken at migraine onset Migraine with or without aura, DNS diagnostic criteria, men and women, age 15-70, n=38 1. Midrid (isometheptene mucate 65 mg, dichloralphenazone 100 mg, paracetamol 325 mg) 2. Ergotamine 1 mg + caffeine 100 mg 2 tabs taken initially, then 1 tab hourly if needed, max 6 tabs in 4 hours Headache and nausea intensity (1=very mild symptoms to 5=very severe symptoms), headache and nausea duration, presence of vomiting Based on 61 headaches treated with Midrid and 61 with ergotamine: Midrid gave significantly better relief of pain and nausea than ergotamine (p<0.025) NSD on duration of headache Duration of nausea, incidence of nausea or vomiting all significantly less o R=1 DB=2 W=0 Total=3
Abbreviations: IHS=International Headache Society; RCT=randomised controlled trial; DB=double blind; CO=crossover; DNS=did not state; NSD=no significant difference; R=randomised; W=withdrawals and dropouts

Last Updated on 3/1/01
By Andrew Moore