Diclofenac with or without an antiemetic for acute migraine headaches in adults.
Author(s): Derry S(1), Rabbie R, Moore RA.
Affiliation(s): Author information:
(1)Pain Research and Nuffield Department of Clinical Neurosciences, University of
Oxford, Oxford, UK. sheena.derry@ndcn.ox.ac.uk.
Publication date & source: 2013, Cochrane Database Syst Rev. , 4:CD008783
BACKGROUND: This review is an update of a previously published review in Issue 2,
2012 (Derry 2012a). 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 (OTC) analgesics.
Diclofenac is an established analgesic, and new formulations using the potassium
or epolamine salts, which can be dissolved in water, have been developed for
rapid absorption, which may be beneficial in acute migraine. Co-therapy with an
antiemetic should help to reduce the nausea and vomiting commonly associated with
migraine.
OBJECTIVES: To determine the efficacy and tolerability of diclofenac, alone or in
combination with an antiemetic, compared to 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), MEDLINE, EMBASE, the Oxford Pain Relief Database, ClinicalTrials.gov,
and reference lists for studies through 27 September 2011 for the original review
and 15 February 2013 for the update.
SELECTION CRITERIA: We included randomised, double-blind, placebo-controlled or
active-controlled studies, or both, using self administered diclofenac to treat a
migraine headache episode, with at least 10 participants per treatment arm.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial
quality and extracted data. We used numbers of participants achieving each
outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat
to benefit (NNT) or harm (NNH) compared to placebo or a different active
treatment.
MAIN RESULTS: Five studies (1356 participants, 2711 attacks) compared oral
diclofenac with placebo, and one also compared it with sumatriptan; none combined
diclofenac with a self administered antiemetic. Four studies treated attacks with
single doses of medication, and two allowed an optional second dose for
inadequate response. Only two studies, with three active treatment arms, provided
data for pooled analysis of primary outcomes. For single doses of diclofenac
potassium 50 mg versus placebo (two studies), the NNTs were 6.2, 8.9, and 9.5 for
pain-free at two hours, headache relief at two hours, and pain-free responses at
24 hours, respectively.Similar numbers of participants experienced adverse
events, which were mostly mild and transient, with diclofenac and placebo.There
were insufficient data to evaluate other doses of oral diclofenac, or to compare
different formulations or different dosing regimens; only one study compared oral
diclofenac with an active comparator (oral sumatriptan 100 mg).
AUTHORS' CONCLUSIONS: Oral diclofenac potassium 50 mg is an effective treatment
for acute migraine, providing relief from pain and associated symptoms, although
only a minority of patients experience pain-free responses. Adverse events are
mostly mild and transient and occur at the same rate as with placebo.
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