| 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 | ||||||