Edwards 2000.
| Methods | Prospective, randomised, double‐blind, parallel‐group trial. 4‐week baseline period. Duration of treatment: 6 weeks titration then 8 weeks stable dosage Discontinuation rate: dropouts: 6 of 15 in topiramate group; 4 of 15 in placebo group Compliance (adherence) data: compliance data reported as number of patients reaching target dose (11 of 15) Rule for use of acute medication: acute medication permitted; allowed types not specified Methodological quality score: 3 |
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| Participants | Inclusion: IHS migraine criteria, migraine onset before age 50, migraine for more than 1 year, migraine frequency 2 to 8 per month, negative pregnancy test Exclusion: daily headaches and analgesic abuse headaches were adequately excluded. Other exclusions: pregnancy or lactation; substance‐related disorder in 3 months prior to study; Axis I disorders; other relevant medical conditions; history of renal calculi; participant in any other clinical trial within 30 days of study onset Setting: not reported (appears to be single‐centre) Country: USA 30 patients recruited and analysed; various analyses undertaken. Patients with and without aura recruited but percentages not reported. 29 females and 1 male; age range 30 to 62. 15 received topiramate and 15 received placebo |
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| Interventions | Topiramate 200 mg/day versus placebo (14 weeks). Dosage started at 25 mg/day and increased by 25 mg each week to reach target dose | |
| Outcomes | Number of migraine attacks per 28 days in entire double‐blind period. Number of migraine attacks per 28 days in last 10 weeks of study. Proportion of responders (50% reduction in frequency). Severity and disability scores Time point(s) considered in the review: through entire double‐blind period |
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| Notes | Funders of the trial: Ortho‐McNeil Pharmaceutical | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information |
| Allocation concealment (selection bias) | Unclear risk | No information |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and clinician were blinded, and placebo was used. No more information |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Data available only from abstract and poster presentation |
| Selective reporting (reporting bias) | High risk | Data available only from abstract and poster presentation |