Mitsikostas 1997.
| Methods | Prospective, randomised, parallel trial. 4‐week baseline period. Duration of treatment: 4 weeks titration, then 4 weeks stable dosage Discontinuation rate: dropout 4.5% for active treatment; 9.1% for the comparison treatment Compliance (adherence) data: compliance was assessed for the active treatment group only by serum valproate concentrations Rule for use of acute medication: sumatriptan or anti‐inflammatory agents only Methodological quality score: 2 |
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| Participants | Inclusion: migraine according to ICHD‐I; migraine onset at least 6 months before screening; at least 3 attacks per month for 6 months; negative brain CT scan. Mixed headaches (with episodic TTH) were included; subgroups cannot be distinguished Exclusion: secondary headaches, daily headaches, and analgesic overuse headache were adequately excluded. Other exclusions: other migraine prophylactic medication in last 6 months, study drug contraindications, hepatic or renal disorder, pregnancy or reproductive intention, chronic use of any other medication during study period Setting: single headache clinic Country: Greece 44 migraine patients participated; 9 with aura and 35 without. 31 females and 13 males; age range 15 to 60 years. 22 received active treatment and 22 received placebo |
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| Interventions | Sodium valproate versus flunarizine (8 weeks). Dosage titrated up to valproate 1000 mg/day or flunarizine 10 mg/day and maintained for 4 weeks | |
| Outcomes | Number of migraine attacks per 28 days. Mean severity of attacks (0 to 10 scale). Mean attack duration (hours). Mean state of physical activity during attacks (0 to 100 scale). Average use of escape medication during 28 days (number of tablets) Time point(s) considered in the review: last (second) month of treatment phase |
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| Notes | Funders of the trial: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Description of method for random sequence generation (1:1 ratio) is lacking |
| Allocation concealment (selection bias) | High risk | No blinding |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | This trial is described as double‐open, which appears equivalent to open‐label |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No information |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Participants not completing study were excluded from the analysis |
| Selective reporting (reporting bias) | Low risk | No suspicion of selective reporting of outcomes, time points, or analyses |