Table 1

Table 1 Randomised, double blind trials of aspirin for acute migraine
          Results  
Reference Patients Design Intervention Outcomes 1 hour Headache response 1 hour pain free response 2 hour Headache response 2 hour pain free response Others Quality scores
Oral studies                    
Lange et al., 1999 Adults with at least one migraine (with or without aura) per month according to IHS criteria, with at least moderate baseline pain RCT, DB, P, multi-centre (Germany), single dose for single attack 1. Effervescent ASA 1000 mg, n = 169 2. Placebo, n = 174 Headache and pain free response at 1 & 2 hours Presence of associated symptoms (nausea, vomiting, photophobia, phonophobia), adverse events 1. 48/169 (28%) 2. 30/174 (17%) NNT 9.0 (95%CI 5.0 to 43) 1. 10/169 (6%) 2. 6/174 (3%) RR 1.7 (0.66 to 4.6) 1. 93/169 (55%) 2. 64/174 (37%) NNT 5.5 (3.5 to 13) 1. 49/169 (24%) 2. 29/174 (17%) NNT 8.1 (4.7 to 28) Number of patients reporting treatment related adverse effects: 1. 14/169 (8%) 2. 0/174 (0%) R=1 DB=1 W=1 Total=3
MacGregor et al., 2000 Adults with at least one migraine (with or without aura) per month according to IHS criteria, with moderate baseline pain (severe migraneurs excluded) RCT, DB, CO, multi-centre (UK), single dose, 2 attacks, rescue medication allowed after two hours 1. Mouth dispersible ASA 900 mg, n = 73 2. Placebo, n = 73 Headache and pain free response at 1 & 2 hours Pain intensity difference, use of rescue, headache recurrence, patient and investigator's global assessment, palatability and convenience, adverse events Results presented for both attacks combined 1. 30/73 (41%) 2. 15/73 (21%) NNT 4.9 (2.8 to 17) 1. 4/73 (5%) 2. 1/73 (1%) RR 4.0 (0.46 to 35) 1. 35/73 (48%) 2. 14/73 (19%) NNT 3.5 (2.3 to 7.0) 1. 10/73 (14%) 2. 4/73 (5%) RR 2.5 (0.8 to 7.6)   R=1 DB=1+1 W=0 Total=3
Boureau et al., 1994 Adults with between two to six migraines (without aura) per month according to IHS criteria, patients with no or mild pain at baseline as study med taken at onset of migraine RCT, DB, CO, multi-centre (France), single dose, 3 attacks, rescue medication allowed after two hours 1. Aspirin 1000 mg, n=193 2. Paracetamol 400 mg plus codeine 25 mg, n=193 3. Placebo, n=198 Headache and pain free response at 1 & 2 hours, pain intensity (VAS), use of rescue, adverse events Results presented for 3 attacks combined nr nr 1. 103/198 (52%) 2. 99/198 (50%) 3. 59/198 (30%) NNT ASA versus placebo 4.5 (3.2 to 7.8) NSD between ASA and paracetamol plus codeine 1. 44/198 (22%) 2. 36/198 (18%) 3. 22/198 (11%) NNT ASA versus placebo 9.0 (5.4 to 26) NSD between ASA and paracetamol plus codeine No serious adverse events reported. NSD between groups for adverse events R=1 DB=1+1 W=1 Total=4
Tfelt-Hanson et al., 1984 Adults with migraines without aura according to a non-IHS criteria, patients with no or mild pain at baseline as study med taken at onset of migraine, nsd between groups at baseline RCT, DB, CO, single dose, 3 attacks, rescue medication allowed after two hours 1. Effervescent aspirin 650 mg, n=85 2. Migravess (effervescent aspirin 650 mg plus metoclopramide 10 mg), n=85 3. Placebo, n=85 Headache pain 4 point scale (none, mild, moderate, severe), nausea similar scale Effect of medication on headache 1 to 4 scale (worse = 1, unchanged =2, better=3, disappeared completely=4). not clear when assessments made Results presented for 3 attacks         Mean effect of treatment: 1. 2.49 2. 2.49 3. 2.01 Aspirin and Migravess significantly better at relieving headache than placebo (p<0.001) Migravess significantly better at relieving nausea than placebo but nsd between other groups. Adverse events: 'Unexpe R=1 DB=1 W=1 Total=3
Hakkarainen et al., 1979 Adults with at least one migraine (with or without aura) per month DNS diagnostic criteria, baseline pain not stated RCT, DB, CO, single dose,8 attacks, rescue medication allowed after two hours 1. Aspirin 500 mg, n=20 2. Tolfenamic acid 200 mg, n=20 3. Ergotamine tartrate 1 mg, n=20 4. Placebo, n=20 Duration, intensity of migraine, non-pain symptoms, functional abliity, use of rescue analgesics and number of adverse events Results presented for all attacks combined         Duration and intensity of attacks significantly less on all active drugs than on placebo ASA (p=0.005),TA (p=0.001), ET (p=0.001) with no significant differences between drugs. Number of adverse events rather than number of patients with an AE reported: A R=1 DB=1 W=0 Total=2
Hakkarainen et al., 1980 Adults with at least two migraines (with or without aura) per month, DNS diagnostic criteria, patients with no or mild pain at baseline as study med taken at onset of migraine RCT, DB, CO, single dose,21 attacks, rescue medication allowed after half hour with second dose study drug 1. Aspirin 500 to 1000 mg, n = 25 2. Doleron novum (dextroprpoxyphene 100 mg, asa 350 mg, phenazone 150 mg) 1 to 2 tabs, n = 25 3. Ergotamine tartrate 1 to 2 mg, n=25 Duration and intensity of migraine, effect on nausea and vomiting, functional ability and adverse events Results presented for all attacks combined         Intensity of attacks: Dextropropoxyphene significantly better than aspirin (p<0.05), nsd between ergotamine and aspirin or ergotamine and dextropropoxyphene. Duration of attacks: Dextropropoxyphene significantly better than aspirin (p<0.01), nsd between e R=1 DB=1+1 W=0 Total=3
Hakkarainen et al., 1978 Adults with at least two migraines (with or without aura) per month, DNS diagnostic criteria, patients with no or mild pain at baseline as study med taken at onset of migraine RCT, DB, CO, single dose,21 attacks, rescue medication allowed after half hour with second dose study drug 1. Aspirin 500 to 1000 mg, n = 25 2. Doleron novum 1 to 2 tabs, n = 25 3. Ergotamine tartrate 1 to 2 mg, n=25 Duration and intensity of migraine, effect non-pain symptoms, functional ability, use of rescue medication and adverse effects Results presented for all attacks combined         Intensity of attacks: Dextropropoxyphene significantly better than aspirin (p<0.001), nsd between ergotamine and dextropropoxyphene or ergotamine and aspirin Duration of attacks: Dextropropoxyphene significantly better than aspirin (p<0.001), and ergotam R=1 DB=1+1 W=1 Total=4
Intravenous studies                    
Taneri et al., 1995 Adults with migraines with and without aura according to IHS criteria. Median VAS at baseline 78 mm aspirin group and 70 mm placebo group RCT, DB, P, single dose, 1 attack 1. Aspirin 500 mg, IV, n=20 2. Placebo, n=20 Pain relief VAS scale every five minutes for one hour, number of patients with at least 50% pain relief, rating of non-pain symptoms (worse, unchanged, better, absent) Patients with at least 50% pain relief at one hour: 1. 13/20 (65%) 2. 4/20 (20%) NNT 2.2 (1.4 to 5.6)         R=1 DB=1 W=1 Total=3
Limroth et al., 1998 Adults with migraine with and without aura according to IHS criteria. Mean VAS at baseline 81 mm (SD 14) both groups, both attacks RCT, DB, CO, single dose, 2 attacks 1. L-aspirin 1000 mg IV, n=56 2.Ergotamine 0.5 mg SC, n=56 Pain relief VAS scale every ten minutes for two hours, number of patients with at least 50% pain relief, rating of non-pain symptoms (none, mild, moderate, severe), adverse effects Results presented for both attacks combined Patients with at least 50% pain relief at one hour: 1. 25/56 (45%) 2. 13/56 (23%) Significantly more patients with 50% pain relief on ASA than ergotamine (p=0.017)   No significant difference between ASA and ergotamine for mean pain intensity difference at two hours, both drugs equally effective, 67% with at least 50% pain relief   Adverse events: 8 patients all reported increased nausea and vomiting: L-ASA 1/56 Ergotamine 7/56 R=1 DB=1 W=1 Total=3
Diener et al., 1999 Adults with two to six migraines (with or without aura) per month according to IHS criteria, with at least moderate to severe baseline pain RCT, DB, P, single dose, 1attack, multi-centre (Germany), rescue medication allowed after two hours 1. Lysine-aspirin 1.8 g IV, n=119 2. Sumatriptan 6 mg SC, n= 114 3. Placebo, n=42 Pain intensity VAS scale every 15 minutes for two hours, headache response and pain free response at two hours four point categorical scale (none, mild, moderate, severe), number of patients with at least 50% pain relief (VAS) recurrence, use of rescue, c 1. 71/119 (60%)) 2. 87/114 (76%) 3. 8/42 (19%) NNT for ASA versus placebo 2.5 (1.8 to 3.4)   1. 88/119 (74%) 2. 104/114 (91%) 3. 10/42 (24%) NNT for ASA versus placebo 2.0 (1.5 to 2.9) 1. 52/119 (44%) 2. 87/114 (76%) 3. 6/42 (14%) NNT for ASA versus placebo 3.4 (2.3 to 6.4) Number of patients reporting treatment related adverse events: 1. 2/119 2. 17/116 3. 1/43 R=1 DB=1+1 W=1 Total=4
Abbreviations: RCT=randomised controlled trial, DB=double blind, P=parallel, CO= crossover, IHS=International Headache Society, ASA=aspirin, VAS= visual analogue scale, AE=adverse event, TA=tolfenamic acid, ET=ergotamine tartrate, NSD=no significant diffe  

Last Updated on 11/12/00
By Andrew Moore