Table: Randomised, double blind controlled trials of naproxen for acute migraine treatment
Reference Patients Design Intervention Outcomes Results (main outcomes) Quality
Andersson et al 1989 Adults with migraine with or without aura, DNS diagnostic criteria, study med taken at first sign migraine, n=37 RCT, DB, CO, 12 attacks, rescue with non-study med at 2 hours 1. Naproxen 750 mg (further doses as required to 1250 mg/day 2. Placebo Headache severity (none, mild, moderate, severe) n=37 analysed for 12 attacks combined # patients with no or mild pain at 2 hours: naproxen 5/37 placebo 0/37 1 patient withdrew due to severe GI pain with naproxen R=1 DB=2 W=1 Total=4
Johnson et al 1985 Adults with migraine with or without aura, DNS diagnostic criteria, study med taken at first sign migraine, n=70 RCT, DB, CO, 10 attacks, rescue with non-study med at 1 hour 1. Naproxen 750 mg 2. Placebo Headache severity (none, mild, moderate, severe), duration, associated symptoms n=37 patients analysed Significantly better pain relief and shorter headache duration with naproxen than placebo Withdrawals due to lack of efficacy: naproxen 12 placebo 14 R=1 DB=1 W=1 Total=3
Nestvold 1986 Adults with migraine with or without aura, DNS diagnostic criteria, study med taken at first sign migraine, n=41 RCT, DB, CO, 6 attacks, rescue at 2 hours with non-study med 1. Naproxen 750 mg to 1000 mg 2. Placebo Headache severity (mild, moderate, severe), duration, associated symptoms, treatment preference by patient n=31 patients analysed Significantly better pain relief and shorter headache duration with naproxen than placebo 44% patients preferred naproxen 9% preferred placebo R=1 DB=2 W=1 Total=4
Sargent et al 1988 Adults with migraine with or without aura, diagnostic criteria per World Federation Neurology, study med taken at migraine onset, n=161 RCT, DB, P, 6 attacks, rescue at 1 hour with non-study med 1. Naproxen sodium 825 to 1100 mg n=39 2. Ergotamine + caffeine 2 to 3 mg n=41 3. Placebo n=42 Headache severity (10 point categorical scale), associated symptoms, patient global assessment n=122 analysed Significantly better pain relief with naproxen than placebo at 1 hour. Number of patients reporting severe adverse effects: naproxen 1/48 ergotamine 8/48 placebo 1/53 3 withdrawals due to adverse effects: 2 ergotamine, 1 naproxen R=1 DB=2 W=1 Total=4
Treves et al 1992 Adults with migraine with or without aura, diagnostic criteria per Ad Hoc committee, study med taken at migraine onset, n=79 RCT, DB, P, 6 attacks, rescue at one hour with 3rd dose of study med similar to second dose or non-study med 1. Naproxen sodium 750 to 1250 mg n=38 2. Ergotamine 2 to 3 mg n=41 Headache severity, associated symptoms (none, mild, moderate, severe), duration, analgesic consumption, patient global n=71 analysed No significant difference between groups for main outcomes. Number of patients reporting adverse effects: naproxen 8, 6 withdrew ergotamine 3, 2 withdrew R=1 DB=1 W=1 Total=3
Abbreviations: RCT=randomised controlled trial; DB=double blind; CO=crossover; P=parallel; R=randomised; W=withdrawals and dropouts; DNS=did not state

Last Updated on 3/1/01
By Andrew Moore