If you take gastro-resistant tablets, swallow them whole, with or after food. Last updated 02 Oct 2021 | 11:44 PM (UTC). Suthisisang 2010 is a metaanalysis of the four included studies in this review that contributed to analyses (Brandes 2007 Study 1; Brandes 2007 Study 2; Smith 2005; Wentz 2008). Single dose to treat a single attack, Sumatriptan 50 mg + naproxen 500 mg, n = 251, Multicentre, multinational, R, DB, PC, parallelgroup, doubledummy study. All studies had an appropriate washout period between any analgesic or other prohibited medication that might interfere with the results and study medication. It may cause side effects. Naproxen is a pain killer, so can be used for the treatment of a toothache (dental pain), however, please consult your doctor before starting any painkillers as there could be an underlying infection which needs to be taken care of along with. 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. Naproxen also helps relieve symptoms of ankylosing spondylitis, which is a type of arthritis that affects the joints in the . It is a pain-killer and is used for treating various painful conditions. Naproxen is not used to treat gallbladder pain. This is especially the case when using the IHS criterion of painfree at two hours as the outcome. One study scored 5/5 (Wentz 2008), three scored 4/5 (S2WA4003; S2WA4004; Smith 2005), and two scored 3/5 (Brandes 2007 Study 1; Brandes 2007 Study 2). This review suggests that naproxen is effective in migraine headache for a small proportion of sufferers. Two studies comparing naproxen 275 mg with naratriptan 2.5 mg (S2WA4003; S2WA4004) provided data on the number of participants reporting any adverse event, but combined data for all attacks over 12 weeks of treatment without any explanation of how this was done, so we were unable to use them. Naproxen is not recommended for the treatment of flu. However, about 1 in 10 (8%) were pain-free at two hours when treated with placebo. Two review authors independently assessed trial quality and extracted data. Q. There were insufficient data for analysis of naproxen compared with sumatriptan, and no data suitable for analysis of naproxen compared with naratriptan. FOIA Allocation concealment (checking for possible selection bias). chronic heart failure. Other symptoms include feeling sick, vomiting, disturbed vision, and sensitivity to light, sound, and smells. Talk to your doctor before taking naproxen, or if your migraine attack is paired with other troubling symptoms. Almost 5 in 10 had some headache relief with naproxen, and 3 in 10 with placebo. We included randomised, doubleblind, placebo or activecontrolled studies using naproxen to treat a migraine headache episode. Talk to your doctor before taking the two medicines together. Effects of naratriptan versus naproxen on daily functioning on the acute treatment of migraine, Naproxen sodium versus ergotamine tartrate in the treatment of acute migraine attacks, Efficacy and safety of a fixed-dose combination of naratriptan and naproxen in acute treatment of migraine (Atenia). All included studies used one or more standard scales to measure PI or PR, and reported outcomes as defined in the Types of outcome measures section. A crosssectional survey of eight EU countries (representing 55% of the adult population) has estimated an annual direct and indirect cost of migraine per person of EUR 1222, and a total annual cost for the EU of EUR 111 billion for adults aged 18 to 65 years (Linde 2012). We were unable to obtain any reports of the individual studies (despite contacting the manufacturer for full details of the trials); the drug did not receive a license from the US Food and Drug Administration (FDA) due to concerns about tardive dyskinesia associated with metoclopramide. In this case, we specified a clinically useful level as an NNT of 8 or greater for painfree at two hours, and NNT 6 or greater for headache relief at two hours. Almost 5 in 10 had some headache relief with naproxen, and 3 in 10 with placebo. Naproxen is not an over the counter (OTC) product. A further 735 participants took sumatriptan 85 mg, and 737 took a combination of sumatriptan 85 mg and naproxen 500 mg (Brandes 2007 Study 1; Brandes 2007 Study 2). All studies used the oral route of administration, and none used multiple dosing strategies. There were insufficient data for analysis. However, interactions can occur. liver problems. Migraine is a common, disabling condition and a burden for the individual, health services, and society. Naproxen is not as good as some other medicines such as ibuprofen or sumatriptan. Migraine with aura is characterised by reversible focal neurological symptoms that develop over a period of at least 5 minutes and last for less than 60 minutes, followed by headache with the features of migraine without aura. Aleve is also used to temporarily reduce fever. In addition, we created a Risk of bias table, which considered sequence generation, allocation concealment, blinding, incomplete outcome data, and study size (Figure 2). No studies employed multiple dosing strategies for individual attacks. See, Minor changes made to definitions of 24hour outcomes and Use of rescue medication in Appendix 1, and 95% confidence intervals added to NNTs in Abstract. Naproxen does not contain aspirin. Naproxen is a nonsteroidal antiinflammatory drug (NSAID); its efficacy in acute migraine has not been established by systematic reviews. The more common side effects that occur with naproxen oral tablet include: stomach pain. . Comparison 1: Naproxen versus placebo, Outcome 7: Relief of associated symptoms. Save 2.20. We would exclude data from outcomes where results from 10% or greater of participants were missing with no acceptable reason provided or apparent. For the IHSpreferred outcome of painfree at two hours, naproxen was better than placebo when taken for moderate or severe PI; the NNT was 11 (8.7 to 17), with 17% and 8% of people being painfree with naproxen and placebo, respectively. Long term use may lead to serious complications such as stomach bleeding and kidney problems. Only one study reported the outcome of headache relief at two hours (Andersson 1989). No data on individual attacks. These are likely to include treating the migraine headache early while pain is mild, and using a low dose initially, with a second dose if response is inadequate. The prevalence of primary headache disorders in Russia: a countrywide survey, www.medicine.ox.ac.uk/bandolier/booth/Migraine/NapORacu.html, Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment. Single dose to treat a single attack, Sumatriptan 85 mg/naproxen 500 mg, n = 370 (364 analysed for efficacy), Oxford Quality Score: R1, DB1, W1. Methodological quality, assessed using the Oxford Quality Scale, was good in all studies. The time over which use of rescue medication was measured was 24 hours. We assessed the methods as: low risk of bias (study states that it was blinded and describes the method used to achieve blinding, eg identical tablets; matched in appearance and smell); unclear risk of bias (study states that it was blinded but does not provide an adequate description of how it was achieved). All studies included participants with or without aura, but none reported results for the two types separately. We assessed the methods used to deal with incomplete data as: low risk (< 10% of participants provided no data without acceptable reason, eg they were randomised but did not have a qualifying headache). Before A trial of metoclopramide vs sumatriptan for the emergency department treatment of migraines. Bethesda, MD 20894, Web Policies No drug-drug interactions have been reported between the two. 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. Stronks DL, Tulen JH, Bussmann HB, Mulder LJ, Passchier J. No. It does not, however, treat any infections, you would need antibiotics for the same. One NSAID is naproxen. The majority were not taking any preventive medication, although onethird met guideline criteria for offering or considering it. Co-therapy with an antiemetic should help to reduce the nausea and vomiting commonly associated with migraine headaches. Jakubowski M, Levy D, Kainz V, Zhang XC, Kosaras B, Burstein R. Sensitization of central trigeminovascular neurons: blockade by intravenous naproxen infusion, Aspirin with or without an antiemetic for acute migraine headaches in adults, Sumatriptan plus naproxen for acute migraine attacks in adults. AE: adverse event; naprox: naproxen; SAE: serious adverse event. (naproxen or Aleve or Anaprox or Antalgin or Feminax or Flanax or Inza or Midol or Miranax or Nalgesin or Naposin or Naprelan or Naprogesic or Naprosyn or Narocin or Proxen or Synflex or Xenobid).mp, Headache/ OR exp Headache and facial pain/. Lifting The Burden: the Global Campaign against Headache and the International Headache Society provided financial support for the editorial process. These are two different drugs which belong to the same group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Issues for potential subgroup analysis were dose, monotherapy versus combination with an antiemetic, route of administration, and formulation. Naproxen can raise your blood pressure, however, it is not a very common side effect. It does not, however, treat any underlying infections if any, you would need antibiotics for the same. The addition of an antiemetic may improve outcomes by alleviating the often incapacitating symptoms of nausea and vomiting, and (at least potentially) by enhancing the bioavailability of the coadministered analgesic. Briefing document for peripheral and central nervous system drugs advisory committee meeting, 4 August 2005, 2005, www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4167B1_01_01-Pozen-Backgrounder.pdf, MT100 for the treatment of migraine, 2005, www.fda.gov/ohrms/dockets/ac/05/briefing/ 2005-4167S1_01_POZEN-Presentation.ppt, Ibuprofen with or without an antiemetic for acute migraine headaches in adults, Prevalence and burden of headache and migraine in Germany, The Nordic Cochrane Centre, The Cochrane Collaboration. Take it with food or milk to prevent upset stomach. 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. We accepted studies reporting treatment of consecutive headache episodes if outcomes for the first, or each, episode were reported separately; firstattack data were used preferentially. In most cases, Naproxen starts working about 1 hour after taking it. Individual studies often are underpowered to determine differences between treatments for adverse events. We excluded six studies because they did not use IHS criteria to diagnose migraine (Andersson 1989; Johnson 1985; Nestvold 1985; Pradalier 1985; Sargent 1988; Treves 1992). and transmitted securely. The placebocontrolled studies evaluated painfree response at two hours and sustained painfree during the 24 hours post dose as the primary outcome measures. History of following migraine variants, according to the ICHD-II, 2004, IHS (International Headache Society): basilar migraine, aura without headache, familial hemiplegic migraine, sporadic hemiplegic migraine or aura with non-migraine headache; Pain measures accepted for the main efficacy outcomes were: We considered only data obtained directly from the participant. Migraine was diagnosed using standard, validated criteria, and outcomes measured were generally those recommended by the IHS as being of clinical relevance, although not all studies reported all the outcomes we sought (eg vomiting). Three studies gave naproxen 500 mg (Brandes 2007 Study 1Brandes 2007 Study 2; Smith 2005), two gave only 275 mg (S2WA4003; S2WA4004), while Wentz 2008 gave naproxen 825 mg as this is the recommended maximum dose in Europe for acute migraine treatment. For all outcomes, we carried out analyses, as far as possible, on a modified intentiontotreat basis, that is we included all participants who were randomised and received an intervention. The present review seeks to determine whether treatment of acute migraine with naproxen plus an antiemetic is in any way superior to treatment with naproxen alone. Mild side effects may go away . Talk to your doctor before taking any medicines for cramps. It's especially effective as an anti-inflammatory agent for arthritis, sprains, sunburns and other inflammation-based pain. However, consult a doctor for the relief of back pain as it is important to find out the cause of back pain before starting any medicines. Naproxen can be taken with codeine. The mean age of participants ranged from 40 to 42 years, and between 81% and 91% were female. Written by ASHP. a blood clot. A large prevalence study in the USA found that over half of migraineurs had severe impairment or required bed rest during attacks. No study had substantial amounts of missing data, and no study was considered to be at high risk of bias. Of these, 198 headaches were treated with naproxen 825 mg, and we analysed by both doses combined and by 500 mg alone. We read full copies of the remaining studies to identify those suitable for inclusion. Cost of healthcare for patients with migraine in five European countries: results from the International Burden of Migraine Study (IBMS). In April 2015, we did not identify any potentially relevant new studies after a restricted search (electronic search strategy run in selected databases). Naproxen and its soluble sodium salt are commonly available as 250 mg and 500 mg tablets (275 mg and 550 mg of sodium salt). Naproxen (500 mg and 825 mg) was better than placebo for pain-free response and headache relief. Consult a doctor if you have a fever as it is important to know the cause of fever before starting any medicines. We excluded studies that did not conceal allocation (eg open list). Additional analyses show that naproxen was superior to placebo for use of rescue medication, and relief of migraineassociated symptoms (nausea, photophobia, and phonophobia) and functional disability, with NNTs of 6 to 10 (Appendix 7). For combined treatment with an antiemetic, the intent was to compare different antiemetics if there were sufficient data. Total = 4, 50200 participants in each treatment arm, Multicentre, R, DB, DD, parallelgroup. Naproxen and ibuprofen belong to the same class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and has a similar way of working, but their effect may vary upon individual response. Naproxen inhibits both COX isoforms. The review will be assessed for further updating in 2020. gas. Most studies required that participants had previously tolerated treatment with an NSAID or had no contraindications, or both. Consult a doctor before taking any antibiotics. sharing sensitive information, make sure youre on a federal Total = 5, Randomised by computergenerated sequence, No concealment of allocations prior to assignments, Not RCT general review of naproxen sodium/metoclopramide formulation from Pozen Inc. Data from the Pozen studies are included in, Did not use IHS diagnostic criteria (or equivalent) for migraine diagnostic criteria judged not equivalent to IHS criteria, Did not use IHS diagnostic criteria (or equivalent) for migraine no diagnostic criteria reported, Supplement article, not original study report (same study as, Low patient numbers (12 only). No studies combined naproxen with an antiemetic. We would have collected data for painfree and headache relief outcomes at one hour if reported and relevant, for example, if a fastacting formulation of the intervention was tested. In a recent review of aspirin with or without an antiemetic for acute migraine (Kirthi 2013), aspirin plus metoclopramide was significantly better than aspirin alone for headache relief and relief of nausea at two hours, but not for painfree at two hours or sustained painfree during the 24 hours post dose. The relative benefit was 2.1 (1.6 to 2.8) (Analysis 1.8) and the NNT was 9.5 (7.0 to 15). Naproxen is a non-steroidal anti-inflammatory drug (NSAID). Migraine is a common, disabling condition and a burden for the individual, health services, and society. Krymchantowski AV, Peixoto P, Higashi R, Silva A Jr, Schutz V. Lysine clonixinate vs naproxen sodium for the acute treatment of migraine: a double-blind, randomized, crossover study. Inform your doctor if you have a history of heart disease or stroke. The prevalence and burden of primary headaches in China: a population-based door-to-door survey, The Cochrane Database of Systematic Reviews, Characteristics of studies awaiting classification, This review will be reassessed for updating in 2020. These factors could lead to an underestimate of treatment effect, and overestimate of safety. Risk may occur early in treatment and may increase with duration of use. ChildrenUse and dose must be determined by your doctor. Abdominal pain, Nausea, Headache, Vomiting, Heartburn, Dizziness, Drowsiness, Flatulence, Constipation, Ringing in ear, Edema (swelling), Gastrointestinal ulcer, Itching, Skin eruptions, Ecchymosis (discoloration of the skin resulting from bleeding underneath), Shortness of breath. We accepted studies that included participants taking stable prophylactic therapy to reduce the frequency of migraine attacks. Migraine prevalence, disease burden, and the need for preventive therapy. Size of circle proportional to size of study (see inset scale). It has been widely used in treating arthritis, menstrual cramps, gout, sprains and strains, and a variety of acute pain conditions. Sustained headache relief during the 24 h post dose. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. We assessed the following for each study. The NNT for twohour headache relief was 4.9 with aspirin 1000 mg (Kirthi 2013), 3.2 with ibuprofen 400 mg (Rabbie 2013), 5.0 with paracetamol 1000 mg (Derry 2013), and 4.0 with oral sumatriptan 50 mg (Derry 2012). Accessibility Aborting a migraine attack: naproxen sodium v ergotamine plus caffeine. The risk may be higher for people who take NSAIDs for a long time or at higher doses, are . The NNTs for twohour painfree and twohour headache relief, at 8 and 6, respectively, were already at the preset limits for determining clinical utility, and so the calculation of how much additional data with null effect would be required to reach that point could not be done (Moore 2008). It's used to treat: rheumatoid arthritis osteoarthritis gout period pain muscle and bone disorders, such as back painand sprains and strains The most common specific adverse events reported in studies were dizziness, paraesthesia, somnolence, nausea, dyspepsia, dry mouth, and abdominal discomfort. We classified participants who took rescue medication as withdrawals due to lack of efficacy, and details are reported under 'Use of rescue medication' (Appendix 7). In situations where you are taking Naproxen twice a day to treat a chronic condition, it can take up to 3 days for it to reach its peak effectiveness. Do not crush or chew them. S2WA4003 and S2WA4004 did not mention prophylaxis, but it seems likely that it was not allowed. Helps you get and maintain an erection when you need it. Extended-release 750-1000 mg orally every day, may temporarily increase to 1500 mg/day if . At two hours, the NNT for painfree 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). You have been prescribed Naproxen to relieve pain and inflammation. Pain. We found six good quality studies with about 2700 people. We used numbers needed to treat (NNT) and pooled percentages as absolute measures of benefit or harm. We assessed publication bias by examining the number of participants in trials with zero effect (RR of 1.0) needed for the point estimate of the NNT to increase beyond a clinically useful level (Moore 2008). Patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention study. In total, 1241 participants took naproxen (275 mg to 825 mg), 229 took sumatriptan 50 mg, 173 took naratriptan 2.5 mg, and 1092 took placebo. For the primary outcome of painfree at two hours, data were available for 1054 headaches treated with naproxen 500 mg or 825 mg and 1085 treated with placebo. Whatever the exact direct and indirect costs are for each country, it is clear that migraine presents a significant economic burden. Stop taking naproxen and get medical help right away if you notice any of these rare but serious side effects: stomach / abdominal pain that doesn't go away, black/tarry stools, vomit that looks . The cost of headache disorders in Europe: the Eurolight project. Naproxen is not clinically useful as a standalone analgesic in acute migraine, as it is effective in fewer than 2 people in 10. 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