A Cochrane review [Abstract] 1 included 5 RCTs with a total of 1356 patients with migraine. The majority of participants were female. It is likely that participants were recruited from migraine clinics with more challenging headaches than the general population. All studies compared oral diclofenac with placebo. Four studies treated attacks with single doses of medication and two allowed an optional second dose for inadequate response. Two studies, with 3 active treatment arms, provided data for pooled analysis of primary outcomes. For single doses of diclofenac 50 mg vs. placebo (2 studies, n=1477), the NNTs were 6.2, 8.9, and 9.5 for pain-free at 2 hours, headache relief at 2 hours, and pain-free responses at 24 hours, respectively. Associated symptoms of nausea, photophobia, phonophobia and functional disability were reduced within 2 hours, and similar numbers of participants experienced adverse events, which were mostly mild and transient. There were insufficient data to evaluate other doses of oral diclofenac, or to compare different formulations or different dosing regimens.
Comment: The quality of the evidence is downgraded by indirectness of evidence (differences in studied patients).
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