Table: Randomised, double blind controlled trials of diclofenac for acute migraine treatment
Reference Patients Design Intervention Outcomes Results (main outcomes) Quality
Oral studies
Dahlof and Bjorkman, 1993 Adults with migraine with or without aura according to IHS criteria, 2 to 8 attacks per month, n=72 RCT, DB, CO, 3 attacks treated, study med taken at migraine onset, rescue allowed after 2 hours 1. Diclofenac 50 mg, 2. Diclofenac 100 mg 3. Placebo Headache severity VAS and categorical (1=none, 2=mild, 3= moderate, 4=severe), associated symptoms, working ability n=61 analysed, data combined for 3 attacks: Significantly more patients achieved headache response at 2 hours with Diclofenac 50 mg or 100 mg than placebo (p<0.01 and p<0.001, respectively). Diclofenac 50 mg 24/61 (39%) Diclofenac 100 mg 27/61 (44%) Pla R=1 DB=2 W=1 Total=4
The Diclofenac K/Sumatriptan Migraine Study Group 1999 Adults with migraine with or without aura according to IHS criteria, 2 to 6 attacks per month, n=156 RCT, DB, CO, 4 attacks treated, study med taken at first sign of migraine pain, rescue med allowed after 2 hours 1. Diclofenac-K 50 mg 2. Diclofenac-K 100 mg 3. Sumatriptan 100 mg 4. Placebo Pain intensity VAS (0-100mm), associated symptoms, working ability, analgesic consumption, headache recurrence, n=115 analysed for all 4 attacks. Diclofenac 50 mg and 100 mg, and sumatriptan 100 mg significantly better than placebo (p<0.001), no different from each other for 2 hour headache response. Number of patients reporting adverse events: Diclofenac 50 mg 19 R=1 DB=2 W=1 Total=4
Massiou et al 1991 Adults with migraine without aura, DNS diagnostic criteria, n=107 RCT, DB, CO, 4 attacks treated, study med taken within 30 mins of migraine onset, rescue allowed after 2 hours 1. Diclofenac 50 to 100 mg 2. Placebo Each drug taken twice Number of attacks aborted after single dose Patient and physician global assessment of efficacy after each attack n=104 patients, analysed, 373 attacks Number of attacks aborted within 2 hours: Diclofenac 50 mg 51/186 (27%) Placebo 35/187 (19%) #adverse events reported: 26/191 attacks with diclofenac 18/191 attacks with placebo R=1+1 DB=1 W=1 Total=4
Intramuscular studies
Del Bene et al 1987 Adults, DNS diagnostic criteria, at least 1 attack per week, n=40 RCT, DB, CO, 6 attacks treated, at least severe baseline migraine intensity, rescue med allowed after 6 hours 1. Diclofenac sodium 75 mg, IM 2. Placebo Pain relief and quality of life VAS (0-100mm), global evaluation symptoms after 3 attacks (1=unchanged, 2=improved, 3=worsened) On pain outcomes diclofenac was significantly better than placebo (p<0.001), associated symptoms (p<0.01) No adverse event information given R=1 DB=2 W=1 Total=4
Karachalios et al 1992 Adults with migraine, non-IHS criteria, at least 2 attacks per month, n=86 RCT, DB, P, 1 attack, DNS baseline pain, Diclofenac 75 mg IM given if pain not relieved after 30 mins or pain recurred within 1 hour 1. Diclofenac 75 to 150 mg IM n= 46 2. Paracetamol 500 mg, IM n=40 Headache severity and duration Complete headache relief at 30 to 35 minutes: Diclofenac 75 mg 40/45 (88%) Paracetamol 500 mg 7/40 (18%) No significant adverse events reported R=1 DB=1 W=1 Total=3
Abbreviations: IHS=International Headache Society; RCT=randomised controlled trial; DB=double blind; CO=crossover; P=parallel; DNS=did not state; VAS=visual analogue scale; NSD=no significant difference; R=randomised; W=withdrawals and dropouts; IM=intram

Last Updated on 6/12/00
By Andrew Moore