title: Diclofenac with or without an antiemetic for acute migraine headaches in adults.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  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).
  
  
  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.
authors: Pain Research and Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK. sheena.derry@ndcn.ox.ac.uk.
authors: Sheena
authors: S
authors: Derry
authors: Roy
authors: R
authors: Rabbie
authors: R Andrew
authors: RA
authors: Moore
mesh_terms: D000208:Acute Disease; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D000932:Antiemetics / Q000008:administration & dosage*; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000150:complications / Q000188:drug therapy*; D009325:Nausea / Q000188:drug therapy / Q000209:etiology; D016032:Randomized Controlled Trials as Topic; D018170:Sumatriptan / Q000008:administration & dosage
chemical_list: D000700:Analgesics; D000932:Antiemetics; D004008:Diclofenac; D018170:Sumatriptan
references: Cephalalgia. 1993 Apr;13(2):117-23
references: 8495453
references: Cochrane Database Syst Rev. 2013 Apr 30;(4):CD008041
references: 23633350
references: Br Med J (Clin Res Ed). 1988 May 7;296(6632):1313-6
references: 3133061
references: BMJ. 1995 Feb 18;310(6977):452-4
references: 7873954
references: Br J Clin Pharmacol. 1975 Feb;2(1):57-63
references: 791318
references: BMJ. 1997 Sep 13;315(7109):635-40
references: 9310564
references: Ann Intern Med. 1987 Aug;107(2):224-33
references: 3300460
references: Cephalalgia. 2004;24 Suppl 1:9-160
references: 14979299
references: Pain. 1997 Aug;72(1-2):95-7
references: 9272792
references: Cephalalgia. 2000 Nov;20(9):765-86
references: 11167908
references: Headache. 2012 Apr;52(4):582-91
references: 22590713
references: Drug Dev Ind Pharm. 2011 Mar;37(3):260-7
references: 20704458
references: Arq Neuropsiquiatr. 2002 Jun;60(2-B):410-5
references: 12131942
references: Cochrane Database Syst Rev. 2012 Feb 15;(2):CD008783
references: 22336852
references: Eur J Clin Pharmacol. 1983;24(6):777-85
references: 6884416
references: Br Med J. 1974 Nov 2;4(5939):265-8
references: 4425854
references: Cephalalgia. 2010 Nov;30(11):1336-45
references: 20959428
references: J Headache Pain. 2010 Aug;11(4):289-99
references: 20473702
references: Cephalalgia. 1991 May;11(2):59-63
references: 1860132
references: Pain. 2010 Sep;150(3):386-389
references: 20627575
references: Headache. 2009 Apr;49(4):498-508
references: 19245386
references: Lancet. 2012 Dec 15;380(9859):2163-96
references: 23245607
references: Control Clin Trials. 1996 Feb;17(1):1-12
references: 8721797
references: Cephalalgia. 2012 Apr;32(5):373-81
references: 22395797
references: Value Health. 2009 Jan-Feb;12(1):55-64
references: 18671771
references: Cochrane Database Syst Rev. 2010 Oct 06;(10):CD008039
references: 20927770
references: Mol Interv. 2009 Feb;9(1):31-9
references: 19299662
references: Int J Epidemiol. 2002 Feb;31(1):140-9
references: 11914310
references: J Headache Pain. 2012 Jul;13(5):361-78
references: 22644214
references: Rev Neurol. 2008 Nov 16-30;47(10):506-8
references: 19012253
references: J Int Med Res. 1987 Jan-Feb;15(1):44-8
references: 3545942
references: Headache. 2004 Feb;44(2):136-41
references: 14756851
references: J Clin Invest. 2001 Jul;108(1):7-13
references: 11435450
references: Headache. 2007 Mar;47(3):355-63
references: 17371352
references: Neurology. 2007 Jan 30;68(5):343-9
references: 17261680
references: Cochrane Database Syst Rev. 2012 Feb 15;(2):CD008615
references: 22336849
references: Neurology. 2005 Feb 8;64(3):463-8
references: 15699376
references: Cephalalgia. 1999 May;19(4):232-40
references: 10376168
references: Cephalalgia. 2010 Sep;30(9):1065-72
references: 20713557
references: Cephalalgia. 1988;8 Suppl 7:1-96
references: 3048700
references: Drugs. 1999 Jun;57(6):991-1003
references: 10400409
references: Headache. 2012 Jan;52(1):3-17
references: 22106869
references: Neurology. 2008 Aug 19;71(8):559-66
references: 18711108
references: Headache. 2006 May;46(5):715-25
references: 16643573
references: Headache. 2009 Jan;49(1):79-89
references: 19125877
references: Cephalalgia. 2006 May;26(5):537-47
references: 16674762
references: Pain. 1996 Aug;66(2-3):239-46
references: 8880846
references: J Headache Pain. 2005 Dec;6(6):429-40
references: 16388337
references: J Headache Pain. 2013 Jan 10;14:1
references: 23566305
references: Pain. 1998 Dec;78(3):209-216
references: 9870574
references: Cochrane Database Syst Rev. 2013 Apr 30;(4):CD008040
references: 23633349
references: Eur J Neurol. 2012 May;19(5):703-11
references: 22136117
references: Cephalalgia. 2007 Jan;27(1):29-34
references: 17212680
references: Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004768
references: 19370609
references: Headache. 1992 Feb;32(2):98-100
references: 1551795