| 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 | ||||||