Table: Randomised, double blind controlled trials of ibuprofen for acute migraine treatment
Reference Patients Design Intervention Outcomes Results (main outcomes) Quality
Ellis et al 1993 Adults with migraine, non-IHS criteria, median baseline pain about 8 (VAS), n=40 RCT, DB, P, 1 attack, rescue med allowed after 60 minutes 1. Ibuprofen 600 mg, n=10 2. Metoclopramide 1 mg IV + ibiprofen 600 mg, n=10 3. Metoclopramide 1 mg IV, n=10 4. Placebo Pain and nausea using VAS (0-10), analgesic consumption NSD between ibuprofen and placebo, metoclopramide significantly better pain relief than placebo at 1 hour. NSD between any active and placebo for nausea. R=1 DB=2 W=0 Total=3
Havanka-Kanniainen 1989 Adults with migraine with or without aura, DNA diagnostic criteria, DNS baseline pain, n=40 RCT, DB, CO, about 10 attacks, rescue allowed after 3 hours 1. Ibuprofen 800 to 1200 mg (400 mg if needed after 30 to 60 mins), n=20 2. Placebo, n=20 Headache intensity (1=mild, 2=moderate, 3=severe), headache duration, nausea and vomiting, working ability, analgesic consumption, Number of attacks evaluated for each patient ranged from 3 to 10. Total number of attacks studied: Ibuprofen 182 Placebo 163 Duration and severity of attacks all significantly less in Ibuprofen than placebo R=1 DB=2 W=1 Total=4
Kloster et al 1992 Adults with or without aura according to IHS criteria, 2 to 6 attacks per month, study med taken at migraine onset, n=36 RCT, DB, CO, 6 attacks, rescue med allowed after 4 hours 1. Ibuprofen 1200 mg 2. Placebo Headache severity (0=none, 1=mild, 2=moderate, 3=severe), and VAS, duration, nausea and vomiting, photophobia, dizziness n=25 patients analysed. Number of attacks studied: Ibuprofen 73 Placebo 73 Duration and severity of attacks significantly lower in Ibuprofen group than placebo. All other outcomes significant also. Number of patients reporting adverse events: Ibuprofen 3 R=1 DB=2 W=1 Total=4
Pearce et al 1983 Adults with migraine with or without aura according to non-IHS criteria, study med taken at migraine onset, n=30 RCT, DB, CO, up to 10 attacks, study med taken 4 to 6 hourly as needed 1. Ibuprofen 400 mg (4 to 6 hourly as needed) 2. Paracetamol 900 mg (4 to 6 hourly as needed) Headache severity (mild, moderate, severe), duration, relief (none, moderate, complete) n=27 patients analysed. Number of attacks studied: Ibuprofen 73 Paracetamol 73 Ibuprofen significantly better than paracetamol at reducing severity and duration of attacks. Number of patients reporting adverse effects: Ibuprofen 2 Paracetamol 3 R=1 DB=2 W=1 Total=4
Sandrini et al 1998 Adults with migraine without aura according to IHS criteria, study med taken when baseline severity at least 60mm (VAS), n=40 RCT, DB, CO, 2 attacks, rescue med allowed after 2 hours 1. Ibuprofen-arginine 400 mg 2. Placebo Headache severity VAS (0-100), pain relief (1=none, 2=slight, 3=moderate, 4=a lot), n=29 patients analysed for both attacks. Ibuprofen significantly better than placebo for all outcomes. Number of patients reporting considerable or complete pain relief at 2 hours: Ibuprofen 15/29 (52%) Placebo 2/29 (7%) NNT 2.2 (1.5 to 4.1) Number of pat R=1 DB=2 W=1 Total=4
Abbreviations: IHS=International Headache Society; RCT=randomised controlled trial; DB=double blind; CO=crossover; DNS=did not state; VAS=visual analogue scale; NNT=number-needed-to-treat; NSD=no significant difference; R=randomised; W=withdrawals and dro

Last Updated on 6/12/00
By Andrew Moore