| Study ID | Treatment | Any AE | Specific AEs | Serious AEs | AE withdrawal | Other withdrawals/exclusions |
|---|---|---|---|---|---|---|
| Boureau 1994 | (1) Aspirin 1000 mg, n = 198 (2) Paracetamol 400 mg + codeine 25 mg, n = 198 (3) Placebo, n = 198 |
(1) 29/198 (2) 36/198 (3) 27/198 |
None | None | 12 pts excl from analyses because of serious protocol deviations | |
| Chabriat 1994 | (1) LAS 1650 mg (= 900 mg aspirin) + metoclopramide 10 mg, n = 126 (2) Placebo, n = 124 |
No usable data | “Minor and transient AE reported” (no numbers): - constipation - nausea - dizziness and/or vertigo |
One patient reported epigastric pain one month after one dose of LAS-MCP and was found to have a gastric ulcer. | None | None |
| Diener 2004a | (1) Effervescent aspirin 1000 mg, n = 147 (2) Sumatriptan 50 mg, n = 135 (3) Placebo, n = 153 |
(1) 19/147 (2) 19/135 (3) 16/153 |
Gastrointestinal: (1) 5/147 (2) 7/135 (3) 7/153 |
None reported | None reported | 2 pts excl from efficacy - did not return diary |
| Diener 2004b | (1) Effervescent aspirin 1000 mg, n = 222 (2) Ibuprofen 400 mg, n = 212 (3) Sumatriptan 50 mg, n = 226 (4) Placebo, n = 222 |
(1) 36/222 (2) 26/212 (3) 45/226 (4) 32/222 |
No data | (1) 1/222 (renal colic) (2) 1/212 (perforated duodenal ulcer) (3) 0/226 (4) 0/222 |
Possibly 2 serious AEs, but unconfirmed | 1 treated pt excluded from analysis - did not return diary |
| Geraud 2002 | (1) Aspirin 900 mg + metoclopramide 10 mg, n = 340 (2) Zolmitriptan 2.5 mg, n = 326 |
(1) 99/340 (2) 133/326 |
Most common: (1) Abdominal pain (5.0%), somnolence (5.0%), asthenia (4.9%) (2) vertigo (6.7%), somnolence (5.5%), paraesthesia (4.3%) |
(1) 5/340 (2) 6/326 |
Over 3 attacks: (1) 5/340 (diarrhoea, palpitations + asthenia, anxiety + dry mouth, phlebitis) (2) 3/326 (dizziness, somnolence, dizziness + vasodilatation) |
Details provided, but numbers are for entire study period and most due to failure to treat 3 attacks. |
| Henry 1995 | (1) Effervescent aspirin 900 mg + metoclopramide 10 mg, n = 152 (2) Placebo, n = 151 |
(1) 31/152 (2) 28/151 |
Vomiting: (1) 8/152, (2) 15/151 Stomach ache: (1) 4/152, (2) 3/151 Somnolence: (1) 4/152, (2) 1/151 |
No data | None reported | None reported, but 45 pts were asleep and did not contribute to the 2 h efficacy evaluation |
| Lange 2000 | (1) Effervescent acetylsalicylic acid 1000 mg, n = 169 (2) Placebo, n = 174 |
(1) 14/169 (2) 5/174 |
Most frequent body systems: (1) whole (5), digestive (3), nervous (3), respiratory (3) (2) whole (3) |
None | None reported | None reported |
| Le Jeunne 1998 | (1) calcium carbasalate (= 900 mg aspirin) plus metoclopramide 10 mg, n = 134 (2) ergotamine tartrate 1 mg plus caffeine 100 mg, n = 132 |
Over 2 attacks: (1) 30/136 (2) 42/132 |
Any GI AE: (1) 9/136, (2) 28/132 Somnolence: (1) 6/136, (2) 5/132 Abdominal pain: (1) 5/136, (2) 12/132 Nausea: (1) 5/136, (2) 11/132 |
(1) 1/136 (pulmonary embolism) (2) 0/132 |
(1) 1/136 (pulmonary embolism) (2) 1/132 (back pain) |
2 pts did not return diary cards |
| Lipton 2005 | (1) Aspirin 1000 mg, n = 205 (2) Placebo, n = 204 |
(1) 18/205 (2) 10/204 |
Nausea: (1) 7/205 (2) 2/204 All other AE ≤1% |
(1) 0/205 (2) 1/204 (perforated appendix) |
Possibly one serious AE, but not confirmed | 4 pts in each group treated non-migraine headaches, so excluded from efficacy analysis |
| MacGregor 2002 | (1) Mouth-dispersible aspirin 900 mg, n = 73 (2) Placebo, n = 73 |
No usable data | Gastrointestinal: (1) 8/73 (dyspepsia, nausea, vomiting) (2) 4/73 (abdominal pain, nausea, vomiting) |
(1) 1/73 (headache) (2) 1/73 (endometriosis) |
(1) 4/73 (nausea, tinnitus, coughing, taste perversion) (2) 0/73 |
28 pts originally randomised were not included in analyses: insufficient attacks (6), unable to complete diary (7), withdrew consent (4), lost to follow-up (4) other (5) |
| Tfelt-Hansen 1995 | (1) LAS 1620 mg (= 900 mg aspirin) + metoclopramide 10 mg, n = 137 (2) Sumatriptan 100 mg, n = 122 (3) Placebo, n = 126 |
Over 3 attacks:(1) 25/137 (2) 37/122 (3) 18/126 |
Most common over 3 attacks: (1) somnolence, abdominal pain, nausea + vomiting (2) nausea + vomiting, fatigue, constriction of throat/chest pain, paraesthesia, somnolence, abdominal pain (3) nausea + vomiting, fatigue |
1 sumatriptan pt had acute AF requiring hospital admission | Over 3 attacks: (1) 1/138 (2) 4/125 (3) 2/126 |
32 pts originally randomised did not have any attacks and 4 took treatment but did not complete diaries |
| Thomson 1992 | (1) Aspirin 900 mg + metoclopramide 10 mg, n = 183 (2) Sumatriptan 100 mg, n = 175 |
Over 3 attacks: (1) 53/183 (2) 74/175 |
Most common over 3 attacks: Nausea and/or vomiting: (1) 14/183, (2) 18/175 Malaise/fatigue: (1) 6/183, (2) 11/175 Dizziness/vertigo: (1) 4/183, (2) 9/175 |
No data | (1) 0/183 (2) 5/175 (headache + faintness + vomiting, scalp tingling + heaviness in chest + globus + prolonged aura, stomach pain, dyspnoea + heaviness in extremities, worsened headache + nausea |
3 pts excl from efficacy because did not return diary cards 87 pts excl from efficacy because had mild or no pain at baseline. |
| Titus 2001 | (1) LAS 1620 mg (= 900 mg aspirin) + metoclopramide 10 mg, n = 125 (2) Ergotamine 2 mg + caffeine 200 mg, n = 121 |
Over multiple attacks and with possible multiple dosing: (1) 21/125 (2) 28/121 |
Most common over multiple attacks: (1) somnolence, diarrhoea, dyspepsia, nausea (2) abdominal pain, malaise, anxiety |
None | (1) 1/125 (sinusitis) (2) 0/121 |
Lost to follow-up, noncooperation, other: (1) 8/125 (2) 6/121 |
pts - participants