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Aspirin for acute migraine

Clinical bottom line:

Aspirin, in a variety of doses and formulations, is effective for the treatment of an acute migraine attack. Efficacy varied between doses and formulations of aspirin, however, in all trials aspirin provided better pain relief than placebo. Approximately 45 to 55% of patients had moderate to severe headache reduced to mild or none at 2 hours with oral aspirin, and 60 to 65% patients had at least 50% pain relief by one hour with intravenous aspirin.

Bandolier pulled together the evidence on the efficacy of aspirin for acute migraine treatment. In a systematic review of all pharmacological treatments for acute migraine (Oldman 2000, submitted), we were unable to include any RCTs of aspirin because they did not meet the strict inclusion criteria for the meta-analysis. This page, therefore, aims to summarise the evidence for the efficacy of aspirin from a collection of disparate trials. There are a number of published RCTs, all double blind, and two new industry sponsored trials of oral aspirin in poster form only at the moment, but both soon to be published in peer reviewed journals.

Inclusion criteria were: treatment of acute migraine with aspirin by any route; randomised allocation to treatment groups; double-blind design; adult population and headache outcomes.


MEDLINE (1966 - July 2000), EMBASE (1980 - June 2000), Cochrane Library (Issue 3, 2000) and the Oxford Pain Relief Database (1950 - 1994). A series of free text searches were undertaken, using generic and trade names for aspirin. No restrictions to language were made.


Ten RCTs [1-10] involving oral or intravenous aspirin were found ( Table 1 ). The trials differed with respect to design, outcome measures and aspirin formulations and doses. Seven were placebo controlled and three were active comparisons. Most had well described methods, one had a quality score of two, six scored three and three scored four out of a maximum of five.

Oral aspirin

Five trials compared oral aspirin with placebo. All of the trials used different doses and formulations of aspirin and were disparate with respect to design and outcome measures thus precluding pooling of data and making direct comparisons between trials. However, in all five trials, aspirin was significantly better than placebo for the main outcomes at one and two hours (Figure 1 and 2). Three of these trials had dichotomous outcomes for calculating NNTs. For the main efficacy outcome, two hour headache response, NNTs ranged from 3.5 to 5.5 ( Table 1 ). For two hour pain free response NNTs ranged from 8.1 to 9.0.

Two trials used only active controls. Whilst these trials were of acceptable quality by criteria of randomisesation and blinding they were of questionable validity. The diagnostic criteria for migraine was unclear, and there was insufficient pain at baseline which is of special importance as an indication of trial sensitivity in the absence of a placebo control. In both studies there was no significant difference between ergotamine and aspirin for reducing the intensity or duration of attacks. A dextropropoxyphene compound was significantly better than aspirin and ergotamine for both outcomes (Table 1).

Intravenous aspirin

Two trials compared intravenous aspirin with placebo (Table 1). For one hour outcomes, NNTs were 2.2 (1.4 to 5.6), n=40 for 500 mg aspirin IV, and 2.5 (1.8 to 3.4), n=161 for 1.8 g L-aspirin (1000 mg aspirin). One trial compared 1000 mg L-aspirin with subcutaneous ergotamine 0.5 mg. Significantly more patients achieved at least 50% pain relief after one hour with aspirin (45%) than ergotamine (23%).

Adverse effects

Few adverse effects were reported for aspirin and they occurred less frequently with aspirin than with ergotamine or sumatriptan. Reliable adverse effect information for single oral doses of aspirin can be found on the Bandolier page listed below.


Direct comparisons between one trial and another are thwarted by differences in trial design, migraine diagnosis, outcomes and doses and formulations of aspirin. Some of the studies assess the efficacy of aspirin for a single attack and some combine several attacks together. Baseline pain varies one trial from another also, so direct comparisons of NNTs for the different trials and outcomes should not be made.


Boureau F, Joubert JM, Lasserre V, Prum B, Delecoeuillerie G. Double-blind comparison of an acetaminophen 400 mg-codeine 25 mg combination versus aspirin 1000 mg and placebo in acute migraine attack. Cephalalgia 1994; 14:156-61

Diener H. Efficacy and safety of intravenous acetylsalicylic acid lysinate compared to subcutaneous sumatriptan and parenteral placebo in the acute treatment of migraine. A double-blind, double-dummy, randomized, multicenter, parallel group study. Cephalalgia 1999; 19:581-8

Hakkarainen H, Gustafsson B, Stockman O. A comparative trail of ergotamine tartrate, acetyl salicylic acid and a dextropropoxyphene compound in acute migraine attacks. Headache 1978; 18:35-9

Hakkarainen H, Vapaatalo H, Gothoni G, Parantainen J. Tolfenamic acid is as effective as ergotamine during migraine attacks. The Lancet 1979; 326-8

Hakkarainen H, Quiding H, Stockman O. Mild analgesics as an alternative to ergotamine in migraine. A comparative trial with acetylsalicylic acid, ergotamine tartrate, and a dextropropoxyphene compound. J Clin Pharmacol 1980; 20:590-5

Lange R, Schwarz JA, Hohn M. Acetylsalicylic acid effervescent 1000 mg (Aspirin) in acute migraine attacks: a multicenter, randomized, double-blind, single-dose, placebo-controlled parallel group study. Cephalalgia 2000; 20: (data from poster, paper to be published in 2000)

Limroth V, May A, Diener DC. Lysine-acetylsalicylic acid in acute migraine attacks. European Neurology 1999; 41:88-93

MacGregor EA, Dowson A, Hirst SG, Davies PTG. A placebo controlled trial of mouth dispersible aspirin in migraine. Poster presentation at Headache World 2000. .

Taneri Z, Petersen-Braun M. Double blind study of intravenous aspirinvs placebo in the treatment of acute migraine attacks. Der Schmerz 1995; 9:124-9

Tfelt-Hansen P, Olesen J. Effervescent metoclopramide and aspirin (Mgravess) versus effervescent aspirin or placebo for migraine attacks: a double-blind study. Cephalalgia 1984; 4:107-11