Paracetamol (acetaminophen) with or without an antiemetic for acute migraine
headaches in adults.
Author(s): Derry S, Moore RA, McQuay HJ.
Affiliation(s): Pain Research and Nuffield Department of Anaesthetics, University of Oxford, West
Wing (Level 6), John Radcliffe Hospital, Oxford, Oxfordshire, UK, OX3 9DU.
Publication date & source: 2010, Cochrane Database Syst Rev. , (11):CD008040
BACKGROUND: 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 analgesics.
Co-therapy with an antiemetic should help to reduce nausea and vomiting commonly
associated with migraine.
OBJECTIVES: To determine the efficacy and tolerability of paracetamol
(acetaminophen), alone or in combination with an antiemetic, compared to placebo
and other active interventions in the treatment of acute migraine in adults.
SEARCH STRATEGY: We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford
Pain Relief Database for studies through 4 October 2010.
SELECTION CRITERIA: We included randomised, double-blind, placebo- or
active-controlled studies using self-administered paracetamol 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. Numbers of participants achieving each outcome were
used to calculate relative risk and numbers needed to treat (NNT) or harm (NNH)
compared to placebo or other active treatment.
MAIN RESULTS: Ten studies (2769 participants, 4062 attacks) compared paracetamol
1000 mg, alone or in combination with an antiemetic, with placebo or other active
comparators, mainly sumatriptan 100 mg. For all efficacy outcomes paracetamol was
superior to placebo, with NNTs of 12, 5.2 and 5.0 for 2-hour pain-free and 1- and
2-hour headache relief, respectively, when medication was taken for moderate to
severe pain. Nausea, photophobia and phonophobia were reduced more with
paracetamol than with placebo at 2 hours (NNTs of 7 to 11); more individuals were
free of any functional disability at 2 hours with paracetamol (NNT 10); and fewer
participants needed rescue medication over 6 hours (NNT 6).Paracetamol 1000 mg
plus metoclopramide 10 mg was not significantly different from oral sumatriptan
100 mg for 2-hour headache relief; there were no 2-hour pain-free data. There was
no significant difference between the paracetamol plus metoclopramide combination
and sumatriptan for relief of "light/noise sensitivity" at 2 hours, but slightly
more individuals needed rescue medication over 24 hours with the combination
therapy (NNT 17).Adverse event rates were similar between paracetamol and
placebo, and between paracetamol plus metoclopramide and sumatriptan. No serious
adverse events occurred with paracetamol alone, but more "major" adverse events
occurred with sumatriptan than with the combination therapy (NNH 32).
AUTHORS' CONCLUSIONS: Paracetamol 1000 mg alone is an effective treatment for
acute migraine headaches, and the addition of 10 mg metoclopramide gives
short-term efficacy equivalent to oral sumatriptan 100 mg. Adverse events with
paracetamol did not differ from placebo; "major" adverse events were slightly
more common with sumatriptan than with paracetamol plus metoclopramide.
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