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Ibuprofen for acute migraine


Clinical bottom line

Ibuprofen is an effective treatment for acute migraine. Most of the trials were methodologically flawed and can only tell us that ibuprofen works and not how well it works. Ibuprofen at doses ranging from 400 to 1200 mg provided significantly better pain relief than placebo in three out of four placebo controlled studies.

A systematic review of ibuprofen was not found so Bandolier pulled together the evidence for this drug for the acute treatment of migraine. Ibuprofen is an NSAID of proven efficacy for other pain conditions, but does it work for migraine?

Systematic review:

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

Search methods

Comprehensive searches of the following databases were made: 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 ibuprofen. There was no restriction to language. Retrieved reports were searched for additional trials. Neither individual authors nor pharmaceutical companies were contacted for unpublished data.


Five RCTs [1-5] were found where 156 patients were randomised to ibuprofen and 126 to placebo ( Table ). One RCT [4] compared ibuprofen with paracetamol (n=30). All of the trials studied oral ibuprofen at doses from 400 to 1200 mg. One trial [5] studied ibuprofen-arginine 400 mg. Although trials were of high quality based on criteria that evaluates randomisation, blinding and withdrawals, they were methodologically flawed in other aspects of trial design.

Only two trials used IHS diagnostic criteria, the other three trials pre-dated IHS criteria and in one of them it did not state which diagnostic criteria were used. In most of the studies it was unclear when the outcomes were assessed, therefore results may have been for more than one dose of study medication. Three of the crossover trials failed to either test for carryover effects or describe a minimum period between attacks to avoid these effects and it was not clear if all patients had sufficient pain at baseline to effectively measure a difference.

The trials were disparate with respect to dosing regimes, number of attacks studied and outcome measures precluding pooling of data for quantitative analysis. A descriptive summary of each trial is provided in the Table, and a summary of the overall results below.

Three of the four placebo controlled studies showed significantly better pain relief with ibuprofen than placebo, one showed no difference. Two of these studies also showed a significant reduction in headache duration with ibuprofen. However, mean duration of migraine with ibuprofen was still as much as four to five hours. The most methodologically sound trial of the five studied ibuprofen-arginine 400 mg, a more rapidly absorbed formulation [5]. All patients had sufficient headache pain when study drug was given (at least 60 mm VAS), two hours later, 15/29 patients given ibuprofen-arginine reported considerable or complete headache relief compared with 2/29 patients given placebo. This represents a significant reduction in headache pain and duration with ibuprofen with an NNT of 2.2 (1.5 to 4.1), albeit on only 29 patients.

One active controlled trial concluded that ibuprofen 400 mg given 4 to 6 hourly was significantly better than paracetamol 900 mg 4 to 6 hourly for the reduction of severity and duration of attacks.

Adverse effects

Over all studies, ibuprofen was well tolerated. No serious adverse effects were reported, all were of mild to moderate intensity.


It is a shame that we do not have better quality studies on ibuprofen in migraine, studies performed with modern entry criteria, and using sensible outcomes. We would then be able to make comparisons with other treatments. Note that the NNT of 2.2 from one small trial is not borne out by a much larger trial of 700 patients in which the NNT was 7.5.

Further reading

1 Ellis GL, Delaney J, DeHart DA, Owens A. The efficacy of metoclopramide in the treatment of migraine headache. Annals of Emergency Medicine 1993; 22:191-5.

2 Havanka-Kanniainen H. Treatment of acute migraine attack: ibuprofen and placebo compared. Headache 1989; 29:507-9.

3 Kloster R, Nestvold K, Vilming ST. A double-blind study of ibuprofen versus placebo in the treatment of acute migraine attacks. Cephalalgia 1992; 12:169-71.

4 Pearce I, Frank GJ, Pearce JM. Ibuprofen compared with paracetamol in migraine. Practitioner 1983; 227:465-7.

5 Sandrini G, Franchini S, Lanfranchi S et al. Effectiveness of ibuprofen-arginine in the treatment of acute migraine attacks. Int. J. Clin. Pharm. Res 1998; XVIII:145-51.

Related topics

Identifier Identifier MI007 - IBUPROFEN FOR ACUTE MIGRAINE: Nov-2000