Study ID | Treatment | Any AE | Serious AE | AE withdrawals | Rescue medication |
Dahlöf 1996 | (1) Paracetamol 500 mg (2) Paracetamol 1000 mg (3) Ketoprofen 25 mg (4) Ketoprofen 50 mg (5) Placebo |
No data Total of 30 adverse events reported within 24 h of treating 178 attacks Most of mild or moderate severity No difference between groups |
None | (2) 1/29 (tinnitus and indigestion) 10 participants did not complete all 5 attacks 1 participant had a major protocol violation (took medication < 72 h after previous dose) |
Not reported, but in Methods, so measured |
Diener 2014 (studies 1‐4 in Migliardi 1994) |
(1) Paracetamol 1000 mg (2) Paracetamol 1000 mg + aspirin 500 mg + caffeine 130 mg (3) Placebo |
(1) 136/1400 (2) 241/1400 (3) 61/702 |
None | None | No data |
Friedman 1987 | (1) Butalbital 100 mg + caffeine 80 mg + paracetamol 650 mg (Fioricet) (2) Paracetamol 600 mg + codeine 60 mg (3) Placebo |
No difference between groups | None | None | No data |
Gatoulis 2012 | (1) Paracetamol 300 mg + codeine 30 mg (2) Aspirin 1000 mg (3) Placebo |
(1) 57/233 (2) 38/223 (3) 19/103 Most mild or moderate Dizziness, somnolence, nausea most common ‐ not different from placebo |
None | None | Time to use of rescue medication not different from (3) for (1), but significantly longer for (2) than (1) Proportion of participants taking rescue medication with (1) significantly different from (3) only at 3 h; (2) significantly different from (3) from 2 h |
Gilbert 1976 | (1) Paracetamol 650 mg (2) Phenyltoloxamine 60 mg (3) Paracetamol 650 mg + phenyltoloxamine citrate 60 mg (Percogesic) (4) Placebo |
Reports participants with individual AEs, not number with any AE Events: (1) 26 (2) 34 (3) 43 (4) 22 |
None | 2 participants dropped out after first period due to AEs ‐ group not given | No data |
Göbel 1996 | (1) Paracetamol 1000 mg (2) Peppermint oil solution 10 g (3) Peppermint oil + paracetamol (4) Placebo |
None | None | None | No data |
Göbel 1998 | (1) Paracetamol 1000 mg (2) Peppermint oil combination (distillate of oelum menthae piperitae, oleum cajeputi, oleum eucalypti, oleum juniperi, and oleum gaultheriae) (3) Placebo |
None | None | None | No data |
Göbel 2001 1 | (1) Paracetamol 1000 g (2) Peppermint oil (oleum menthae piperitae) solution Ll 170, 10 g (3) Peppermint oil + paracetamol (4) Placebo |
Reports number of events, not number of participants with any AE (1) 15 (4) 13 |
None | None | No data |
Mehlisch 1998 | (1) Paracetamol 1000 mg (2) Ketoprofen 12.5 mg (3) Ketoprofen 25 mg (4) Placebo |
(1) 16/174 (2) 18/181 (3) 27/176 (4) 8/172 |
None | None 72 participants not included in efficacy analysis: 5 protocol violations, 67 did not record data properly |
At 4 h: (1) 16/166 (2) 10/158 (3) 7/156 (4) 30/151 |
Migliardi 1994 | Studies 5, 6 (1) Paracetamol 1000 mg (2) Paracetamol 1000 mg + caffeine 130 mg (3) Placebo |
(1) 90/691 (2) 144/692 (3) 41/341 Most were stomach upset, nervousness, dizziness. All transient |
None | None | No data |
Miller 1987 | (1) Paracetamol 650 mg (2) Naproxen sodium 550 mg (3) Placebo |
(1) 4/43 (2) 7/40 (3) 2/41 None considered "clinically significant" [Note: total number of participants given as 128 ‐ do not know to which groups additional 4 belonged] |
None | None | At 6 h: (1) 15/43 (2) 7/40 (3) 19/41 |
NCT01755702 | (1) Paracetamol 1000 mg (2) Paracetamol + caffeine 1000 + 130 mg (3) Ibuprofen 400 mg (4) Placebo |
(1) 0/45 (2) 2/47 (3) 4/50 (4) 3/45 |
None | Withdrawal during washout periods: period 1 = 3 period 2 = 5 Reasons and groups not given. No withdrawals during treatment periods (except for remedication ‐ lack of efficacy) |
Median (range) time (minutes) to use (1) 129.5 (129‐130) (2) 119 (119‐119) (3)150 (126‐211) (4) 62 (62‐149) |
NL9701 | (1) Paracetamol 1000 mg (2) Ibuprofen 400 mg (3) Placebo |
(1) 22/190 (2) 23/194 (3) 8/97 |
None | 32 participants not analysed as did not take medication 8 participants excluded due to major protocol violations No withdrawals following treatment (except for remedication ‐ lack of efficacy) |
At 6 h: (1) 18/188 (2) 25/191 (3) 19/94 |
Packman 2000 | (1) Paracetamol 1000 mg (2) Ibuprofen liquigel 400 mg (3) Placebo |
None | None | None | No data |
Peters 1983 | (1) Paracetamol 1000 mg (2) Aspirin 650 mg (3) Placebo |
Number of participants with AEs not reported. No difference between groups Mostly mild |
None | None (38 protocol violations) |
No data |
Pini 2008 | (1) Paracetamol 1000 mg + caffeine 130 mg (2) Naproxen sodium 550 mg (3) Placebo |
(1) 36.6% (2) 31.2% (3) 36.6% Denominator unclear. Most mild or moderate: nervousness, nausea, drowsiness, and fatigue most common Global assessment of tolerability (very good or excellent): (1) 45.7% (2) 51.6% (3) 41.7% |
None | (1) 1/98 (2) 0/94 (3) 0/98 |
(1) 4.8% (2) 3.3% (3) 10% Denominator unclear |
Prior 2002 | (1) Paracetamol 1000 mg (2) Naproxen 375 mg (3) Placebo |
(1) 31/308 (2) 35/300 (3) 30/307 |
None | None | At 6 h: (1) 53/304 (2) 49/295 (3) 77/301 Mean time to use (minutes) (1) 324 (2) 326 (3) 308 |
Schachtel 1991 | (1) Paracetamol 1000 mg (2) Aspirin 1000 mg + caffeine 64 mg (3) Placebo |
(1) 0/100 (2) 0/101 (3) 1/101 |
None | None | At 4 h: (1) 2/100 (2) 2/101 (3) 13/101 |
Schachtel 1996 | (1) Paracetamol 1000 mg (2) Ibuprofen 400 mg (3) Placebo |
(1) 0/151 (2) 0/153 (3) 1/151 |
None | None | No data |
Steiner 1998 | (1) Paracetamol 1000 mg (2) Ketoprofen 25 mg (3) Placebo |
(1) 10/116 (2) 15/102 (3) 12/112 |
None | None | 2‐24 h: (1) 53/116 (2) 44/102 (3) 81/112 |
Steiner 2003 | (1) Paracetamol 500 mg (2) Paracetamol 1000 mg (3) Aspirin 500 mg (4) Aspirin 1000 mg (5) Placebo |
(1) 17/105 (2) 19/111 (3) 21/111 (4) 19/103 (5) 15/112 All mild, transient |
None | None | After 2 h: (1) 27/105 (2) 22/111 (3) 18/111 (4) 16/103 (5) 38/112 |
Thorpe 1970 | (1) Fiorinal‐Pa (aspirin + caffeine + isobutylallylbarbituric acid + paracetamol) (2) Placebo |
No data | No data | No data | No data |
Ward 1991 | (1) Paracetamol 648 mg (2) Paracetamol 648 mg + caffeine 65 mg (3) Paracetamol 648 mg + caffeine 130 mg (4) Caffeine 65 mg (5) Caffeine 130 mg (6) Placebo |
No data | No data | No data | No data |
AE: adverse event; h: hour. |