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 (95% CI 8.7 to 17) (17% response with naproxen, 8% with placebo; risk ratio 2.0 (1.6 to 2.6), moderate quality) and for headache relief was 6.0 (4.8 to 7.9) (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 (13 to 34) (12% response with naproxen, 6.7% with placebo), and for sustained headache relief during the 24 hours post dose was 8.3 (6.4 to 12) (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.
Plain language summary
Naproxen for acute migraine in adults
Migraine is a complex condition with a wide variety of symptoms. For many people the main feature is a painful headache. Other symptoms include feeling sick, vomiting, disturbed vision, and sensitivity to light, sound, and smells.
Non-steroidal anti-inflammatory drugs (NSAIDs) are used to treat migraine headaches. One NSAID is naproxen. On 22 May 2013, we looked for clinical trials where naproxen was used to treat migraine headache. We found six good quality studies with about 2700 people.
Naproxen was more effective than placebo for relieving migraine headache in adults, but only weakly so. From having headache pain described as moderate or severe, about 2 in 10 people (17%) were pain-free at two hours when treated with naproxen. However, about 1 in 10 (8%) were pain-free at two hours when treated with placebo. Almost 5 in 10 had some headache relief with naproxen, and 3 in 10 with placebo. Naproxen is not as good as some other medicines such as ibuprofen or sumatriptan. More dizziness, tingling sensations (paraesthesia), sleepiness (somnolence), nausea, indigestion (dyspepsia), dry mouth, and abdominal discomfort were reported with the 825 mg dose. These effects were generally of mild to moderate severity and rarely led to withdrawal from the studies.
Naproxen is not a good drug for treating migraine at the doses of 500 mg or 825 mg used in the studies we found.
