Ibuprofen with or without an antiemetic for acute migraine headaches in adults

Roy Rabbie; Sheena Derry; R Andrew Moore

doi:10.1002/14651858.CD008039.pub3

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Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 2

Forest plot of comparison: 2 Ibuprofen 400 mg versus placebo, outcome: 2.1 Pain‐free at 2 hours.

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Figure 3

L'Abbé plot showing 2‐hour pain‐free response for ibuprofen versus placebo. Size of circle is proportional to size of study. Cream ‐ 200 mg; Yellow ‐ 400 mg; Brown ‐ 600 mg ibuprofen

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Figure 4

Forest plot of comparison: 2 Ibuprofen 400 mg versus placebo, outcome: 2.2 Headache relief at 2 hours.

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Figure 5

L'Abbé plot showing 2‐hour headache relief for ibuprofen versus placebo. Size of circle is proportional to size of study. Cream ‐ 200 mg; Yellow ‐ 400 mg; Brown ‐ 600 mg ibuprofen

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Figure 6

L'Abbé plot showing 1‐hour headache relief for ibuprofen versus placebo. Size of circle is proportional to size of study. Cream ‐ 200 mg; Yellow ‐ 400 mg; Brown ‐ 600 mg ibuprofen

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Analysis 1.1

Comparison 1 Ibuprofen 200 mg versus placebo, Outcome 1 Pain‐free at 2 hours.

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Analysis 1.2

Comparison 1 Ibuprofen 200 mg versus placebo, Outcome 2 Headache relief at 2 hours.

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Analysis 1.3

Comparison 1 Ibuprofen 200 mg versus placebo, Outcome 3 Headache relief at 1 hour.

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Analysis 1.4

Comparison 1 Ibuprofen 200 mg versus placebo, Outcome 4 Any adverse event within 24 hours.

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Analysis 1.5

Comparison 1 Ibuprofen 200 mg versus placebo, Outcome 5 Participants using rescue medication.

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Analysis 1.6

Comparison 1 Ibuprofen 200 mg versus placebo, Outcome 6 Relief of associated symptoms at 2 h.

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Analysis 1.7

Comparison 1 Ibuprofen 200 mg versus placebo, Outcome 7 Relief of functional disability at 2 hours.

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Analysis 2.1

Comparison 2 Ibuprofen 400 mg versus placebo, Outcome 1 Pain‐free at 2 hours.

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Analysis 2.2

Comparison 2 Ibuprofen 400 mg versus placebo, Outcome 2 Headache relief at 2 hours.

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Analysis 2.3

Comparison 2 Ibuprofen 400 mg versus placebo, Outcome 3 Headache relief at 1 hour.

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Analysis 2.4

Comparison 2 Ibuprofen 400 mg versus placebo, Outcome 4 Sustained headache relief over 24 hours.

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Analysis 2.5

Comparison 2 Ibuprofen 400 mg versus placebo, Outcome 5 Any adverse event within 24 hours.

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Analysis 2.6

Comparison 2 Ibuprofen 400 mg versus placebo, Outcome 6 Specific adverse events.

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Analysis 2.7

Comparison 2 Ibuprofen 400 mg versus placebo, Outcome 7 Participants using rescue medication.

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Analysis 2.8

Comparison 2 Ibuprofen 400 mg versus placebo, Outcome 8 Relief of associated symptoms at 2 h.

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Analysis 2.9

Comparison 2 Ibuprofen 400 mg versus placebo, Outcome 9 Relief of functional disability at 2 hours.

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Analysis 3.1

Comparison 3 Ibuprofen 400 mg versus rofecoxib 25 mg, Outcome 1 Headache relief at 2 hours.

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Analysis 3.2

Comparison 3 Ibuprofen 400 mg versus rofecoxib 25 mg, Outcome 2 Sustained headache relief over 24 hours.

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Analysis 3.3

Comparison 3 Ibuprofen 400 mg versus rofecoxib 25 mg, Outcome 3 Participants using rescue medication.

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Analysis 4.1

Comparison 4 Ibuprofen 600 mg versus placebo, Outcome 1 Pain‐free at 2 hours.

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Analysis 4.2

Comparison 4 Ibuprofen 600 mg versus placebo, Outcome 2 Headache relief at 2 hours.

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Ibuprofen 400 mg compared with placebo for migraine headache
Patient or population: adults with migraine headache ‐ moderate or severe pain Settings: community Intervention: ibuprofen 400 mg Comparison: placebo
Outcomes	Probable outcome with intervention	Probable outcome with comparator	NNT or NNTH and/or relative effect (95% CI)	No of studies, attacks, events	Quality of the evidence (GRADE)	Comments
Pain free response at 2 h	260 in 1000	120 in 1000	NNT 7.2 (5.9 to 9.2)	6 studies, 2575 attacks, 529 events	Moderate¹
Headache relief at 2 h	250 in 1000	570 in 1000	NNT 3.2 (2.8 to 3.7)	7 studies, 1815 attacks, 752 events	Moderate¹
Sustained pain‐free at 24 h	no data
Sustained headache relief at 24 h	190 in 1000	450 in 1000	NNT 4.0 (3.2 to 5.2)	4 studies, 879 attacks, 288 events	Moderate¹
At least one AE	180 in 1000	150 in 1000	NNH 26 (15 to 100)	8 studies, 2722 attacks, 441 events	Moderate¹
Serious AE	insufficient data
CI: Confidence interval; NNT: number needed to treat; NNH: number needed to harm
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
1 ‐ Quality of evidence downgraded from high because of threat from potential publication bias with modest effect size and numbers of events

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Comparison 1. Ibuprofen 200 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain‐free at 2 hours Show forest plot	2	777	Risk Ratio (M‐H, Fixed, 95% CI)	1.96 [1.36, 2.81]

2 Headache relief at 2 hours Show forest plot	2	777	Risk Ratio (M‐H, Fixed, 95% CI)	1.37 [1.17, 1.61]

3 Headache relief at 1 hour Show forest plot	2	777	Risk Ratio (M‐H, Fixed, 95% CI)	1.45 [1.15, 1.83]

4 Any adverse event within 24 hours Show forest plot	2	780	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.67, 1.08]

5 Participants using rescue medication Show forest plot	2	777	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.58, 0.86]

6 Relief of associated symptoms at 2 h Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 Nausea	2	429	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [1.06, 1.67]
6.2 Photophobia	2	751	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.05, 1.85]
6.3 Phonophobia	2	724	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.08, 1.82]
7 Relief of functional disability at 2 hours Show forest plot	2	757	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.18, 1.66]

Comparison 1. Ibuprofen 200 mg versus placebo

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Comparison 2. Ibuprofen 400 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain‐free at 2 hours Show forest plot	6	2575	Risk Ratio (M‐H, Fixed, 95% CI)	1.91 [1.60, 2.28]

2 Headache relief at 2 hours Show forest plot	7	1815	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [1.92, 2.45]

2.1 Standard formulation	5	1424	Risk Ratio (M‐H, Fixed, 95% CI)	2.49 [2.12, 2.91]
2.2 "Soluble" formulation	2	391	Risk Ratio (M‐H, Fixed, 95% CI)	1.59 [1.32, 1.92]
3 Headache relief at 1 hour Show forest plot	4	1269	Risk Ratio (M‐H, Fixed, 95% CI)	1.89 [1.54, 2.30]

3.1 Standard formulation	2	878	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [1.34, 2.27]
3.2 "Soluble" formulation	2	391	Risk Ratio (M‐H, Fixed, 95% CI)	2.12 [1.55, 2.89]
4 Sustained headache relief over 24 hours Show forest plot	4	879	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [1.76, 2.69]

5 Any adverse event within 24 hours Show forest plot	7	2656	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.82, 1.15]

6 Specific adverse events Show forest plot	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 Nausea	7	2297	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.54, 1.00]
6.2 Abdominal pain	6	2230	Risk Ratio (M‐H, Fixed, 95% CI)	2.36 [1.12, 4.96]
6.3 Dizziness	3	1615	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.46, 2.22]
6.4 Somnolence	4	1717	Risk Ratio (M‐H, Fixed, 95% CI)	2.53 [0.79, 8.17]
7 Participants using rescue medication Show forest plot	7	1815	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.61, 0.74]

8 Relief of associated symptoms at 2 h Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 Nausea	3	634	Risk Ratio (M‐H, Fixed, 95% CI)	1.54 [1.27, 1.86]
8.2 Vomiting	2	93	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [1.21, 1.92]
8.3 Photophobia	4	1328	Risk Ratio (M‐H, Fixed, 95% CI)	1.51 [1.29, 1.77]
8.4 Phonophobia	4	1261	Risk Ratio (M‐H, Fixed, 95% CI)	1.63 [1.39, 1.90]
9 Relief of functional disability at 2 hours Show forest plot	3	1114	Risk Ratio (M‐H, Fixed, 95% CI)	1.61 [1.38, 1.89]

Comparison 2. Ibuprofen 400 mg versus placebo

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Comparison 3. Ibuprofen 400 mg versus rofecoxib 25 mg

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Headache relief at 2 hours Show forest plot	2	444	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.85, 1.17]

2 Sustained headache relief over 24 hours Show forest plot	2	444	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.66, 1.10]

3 Participants using rescue medication Show forest plot	2	444	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.95, 1.38]

Comparison 3. Ibuprofen 400 mg versus rofecoxib 25 mg

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Comparison 4. Ibuprofen 600 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain‐free at 2 hours Show forest plot	1	340	Risk Ratio (M‐H, Fixed, 95% CI)	2.19 [1.37, 3.51]

2 Headache relief at 2 hours Show forest plot	1	340	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [1.19, 1.73]

Comparison 4. Ibuprofen 600 mg versus placebo

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