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Diclofenac for acute migraine

Clinical bottom line

The evidence from a small number of randomised, double blind trials shows that diclofenac is more effective than placebo for the relief of migraine headache. In all studies, diclofenac 50 to 100 mg (oral) or 75 mg (intramuscular) provided significantly better pain relief than placebo. Whilst these data demonstrate that diclofenac is effective, they are unable to demonstrate how effective it is, thus direct comparison with other migraine treatments is hampered.

A systematic review of diclofenac was not found so Bandolier pulled together the evidence for this drug for the acute treatment of migraine. Diclofenac is an NSAID of proven efficacy for other pain conditions, with a license for the treatment of acute migraine. But how well does it work?

Systematic review:

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

Search methods

A comprehensive search of the following databases was 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 diclofenac. 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 Neither individual authors nor pharmaceutical companies were contacted for unpublished data.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 461 patients were randomised to diclofenac and 375 to placebo ( Table ). Three trials [1-3] studied oral diclofenac 50 to 100 mg, and two [4,5] intramuscular (IM) diclofenac 75 to 150 mg. One RCT [5] compared diclofenac with paracetamol (n=40).

Trials were of high quality based on criteria that evaluates randomisation, blinding and withdrawals (scores of 3 or 4 out of 5). Only two trials used IHS diagnostic criteria, the other three trials pre-dated IHS criteria and in two of them it was not clear what, if any, diagnostic criteria were used. The trials were disparate with respect to dosing regimes, number of attacks studied and outcome measures precluding pooling of data for quantitative analysis.

In the four placebo controlled studies, diclofenac at all doses and routes was significantly better than placebo for the main outcomes. In the one active comparison, 40/45 (88%) patients that received diclofenac 75 mg IM achieved complete headache relief after about 35 minutes compared with 7/40 (18%) with paracetamol 500 mg IM. Dichotomous data were available for four comparisons in three studies and are shown in the L'abbe plot (Figure). There is insufficient data to determine either a dose response relationship or a difference due to route of administration.

Adverse effects

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



Not too much information here to base advice to patients, but evidence that NSAIDs have some effect.

Further reading

1 Dahlof C, Bjorkman R. Diclofenac-K (50 and 100 mg) and placebo in the acute treatment of migraine. Cephalalgia 1993; 13:117-23.

2 The Diclofenac-K/Sumatriptan Migraine Study Group. Acute treatment of migraine attacks: efficacy and safety of a nonsteroidal anti-inflammatory drug, diclofenac-potassium, in comparison to oral sumatriptan and placebo. Cephalalgia 1999; 19:232-40.

3 Massiou H, Serrurier D, Lasserre O, Bousser MG. Effectiveness of oral diclofenac in the acute treatment of common migraine attacks: a double-blind study versus placebo [see comments]. Cephalalgia 1991; 11:59-63.

4 Del Bene E, Poggioni M, Garagiola U, Maresca V. Intramuscular treatment of migraine attacks using diclofenac sodium: a crossover clinical trial. J Int Med Res 1987; 15:44-8.

5 Karachalios GN, Fotiadou A, Chrisikos N, Karabetsos A, Kehagioglou K. Treatment of acute migraine attack with diclofenac sodium: a double-blind study. Headache 1992; 32:98-100.

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