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Meta-Analysis
. 2013 Oct 20;2013(10):CD009455.
doi: 10.1002/14651858.CD009455.pub2.

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

Affiliations
Meta-Analysis

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

Simon Law et al. Cochrane Database Syst Rev. .

Abstract

Background: Migraine is a common, disabling condition and a burden for the individual, health services, and society. Many sufferers choose not to, or are unable to, seek professional help and rely on over-the-counter analgesics. Naproxen is a non-steroidal anti-inflammatory drug (NSAID); its efficacy in acute migraine has not been established by systematic reviews. Co-therapy with an antiemetic should help to reduce the nausea and vomiting commonly associated with migraine headaches.

Objectives: To determine the efficacy and tolerability of naproxen, alone or in combination with an antiemetic, compared with placebo and other active interventions in the treatment of acute migraine headaches in adults.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, MEDLINE, EMBASE, and the Oxford Pain Relief Database, together with two online databases (www.gsk-clinicalstudyregister.com and www.clinicaltrials.gov) and reference lists, for studies to 22 May 2013.

Selection criteria: We included randomised, double-blind, placebo- or active-controlled studies, with at least 10 participants per treatment arm, using naproxen alone or with an antiemetic to treat a migraine headache episode.

Data collection and analysis: Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate risk ratios and numbers needed to treat (NNT) or harm (NNH) compared with placebo or a different active treatment.

Main results: We included six studies using naproxen 275 mg, 500 mg, or 825 mg to treat attacks of moderate or severe pain intensity. Overall, 1241 participants took naproxen (275 mg to 825 mg), 229 took sumatriptan 50 mg, 173 took naratriptan 2.5 mg, and 1092 took placebo. No studies combined naproxen with an antiemetic. Studies using naproxen 275 mg provided no useable data for analysis.Naproxen (500 mg and 825 mg) was better than placebo for pain-free response and headache relief. At two hours, the NNT for pain-free response was 11 (17% response with naproxen, 8% with placebo; risk ratio 2.0 (95% CI 1.6 to 2.6), moderate quality) and for headache relief was 6.0 (45% response with naproxen, 29% with placebo; risk ratio 1.6 (1.4 to 1.8), moderate quality). The NNT for sustained pain-free response during the 24 hours post dose was 19 (12% response with naproxen, 6.7% with placebo), and for sustained headache relief during the 24 hours post dose was 8.3 (30% response with naproxen, 18% with placebo). Analysing only the lower dose of 500 mg of naproxen did not significantly change the results. Adverse events, which were mostly mild or moderate in severity and rarely led to withdrawal, were more common with naproxen than with placebo when the 500 mg and 825 mg doses were considered together, but not when the 500 mg dose was analysed alone.There were insufficient data for analysis of naproxen compared with sumatriptan, and no data suitable for analysis of naproxen compared with naratriptan.

Authors' conclusions: Naproxen is statistically superior to placebo in the treatment of acute migraine, but the NNT of 11 for pain-free response at two hours suggests that it is not a clinically useful treatment. Cochrane reviews examining other commonly used analgesics for acute migraine have reported better (lower) NNT results for the same outcome. Naproxen is not clinically useful as a stand-alone analgesic in acute migraine, as it is effective in fewer than 2 people in 10.

PubMed Disclaimer

Conflict of interest statement

RAM has consulted for various pharmaceutical companies and has received lecture fees from pharmaceutical companies related to analgesics and other healthcare interventions. RAM and SD have received research support from charities, government, and industry sources at various times. SL has no interests to declare.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Forest plot of comparison: 1 Pain, outcome: 1.1 Pain‐free response at two hours.
4
4
L'Abbé plot for pain‐free response at two hours. Size of circle proportional to size of study (see inset scale). Cream = naproxen 500 mg, blue = naproxen 825 mg.
5
5
Forest plot of comparison: 1 Pain, outcome: 1.4 Headache relief at two hours.
6
6
L'Abbé plot for headache relief at two hours. Size of circle proportional to size of study (see inset scale). Cream = naproxen 500 mg, blue = naproxen 825 mg.
1.1
1.1. Analysis
Comparison 1: Naproxen versus placebo, Outcome 1: Pain‐free response at 2 h
1.2
1.2. Analysis
Comparison 1: Naproxen versus placebo, Outcome 2: Headache relief at 2 h
1.3
1.3. Analysis
Comparison 1: Naproxen versus placebo, Outcome 3: 24‐h sustained pain‐free
1.4
1.4. Analysis
Comparison 1: Naproxen versus placebo, Outcome 4: 24‐h sustained headache relief
1.5
1.5. Analysis
Comparison 1: Naproxen versus placebo, Outcome 5: Any adverse event
1.6
1.6. Analysis
Comparison 1: Naproxen versus placebo, Outcome 6: Use of rescue medication
1.7
1.7. Analysis
Comparison 1: Naproxen versus placebo, Outcome 7: Relief of associated symptoms
1.8
1.8. Analysis
Comparison 1: Naproxen versus placebo, Outcome 8: Relief of functional disability

Update of

  • doi: 10.1002/14651858.CD009455

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