Afshari 2012.
| Methods | Prospective, randomised, double‐blind, parallel‐group trial. The study consisted of a 4‐week baseline period (possibly retrospective) and a prospective treatment period of 12 weeks Discontinuation rate: topiramate 30%, sodium valproate 22% Compliance (adherence) data: not available Rule for use of acute medication: during acute attacks, patients were allowed to use acetaminophen, NSAIDs, ergotamine, triptans, and opioids Methodological quality score: 3 |
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| Participants | Inclusion: migraine with or without aura according to ICHD‐II; migraine onset at least 6 months prior to study and before age 50; migraine frequency 4 to 10 attacks per month; attacks separated by 48 h pain‐free interval. Ages 18 to 65. Non‐pregnant, non‐lactating adequate contraception. Migraine prophylaxis withdrawn at least 1 month prior to study entry Exclusion: non‐migraine headaches; > 8 treatment days/month of ergots, NSAIDs, or triptans. No rule reported for exclusion of CDH Other exclusions: alcohol/drug dependence. Hemiplegic, basilar, or ophthalmoplegic migraine. Serious medical conditions Setting: single‐centre Country: Iran Intention‐to‐treat analysis of 56 patients. Of these, 9 had migraine with aura and 47 migraine without aura (ie, not stated that some had both). 44 females and 12 males included in the ITT analysis; mean age among ITT participants treated with topiramate 32.1 ± 10.2; mean age among ITT participants treated with sodium valproate 29.2 ± 9.6. 40 allocated to receive topiramate; 36 allocated to receive sodium valproate |
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| Interventions | Topiramate 50 mg/day versus sodium valproate 400 mg/day (12 weeks). Topiramate initiated with 25 mg/day for 1 week, thereafter 50 mg/day until study end. Dosing frequency not stated. Sodium valproate initiated with 200 mg/day for 1 week, thereafter 400 mg/day until study end. Dosing frequency not stated | |
| Outcomes | Headache frequency (4 weeks). Headache severity. Duration of episode. Weight. MIDAS at baseline and 8 weeks. HIT‐6 at baseline and 8 weeks. Responder rate Time point(s) considered in the review: last (third) month of double‐blind phase for frequency; entire double‐blind phase for MIDAS |
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| Notes | A migraine attack persisting longer than 72 hours was counted as a new distinct migraine period. This outcome measure runs the risk of confounding reductions in migraine frequency with reductions in attack duration. Since it is unclear if the baseline was prospective, change scores from baseline were excluded from the analyses of this review. Complementary information requested by email (twice) and ordinary letter (once) but not provided by corresponding author Funders of the trial: Kermanshah University of Medical Sciences, Iran |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation schedule |
| Allocation concealment (selection bias) | Low risk | Medication prescribed with preprinted medication code labels |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Stated that both participants and clinicians were blinded by the use of preprinted medication code labels. However, there is no mention of equally appearing tablets. It is thus possible that standard medication was provided by third party according to allocation label |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 20 randomised patients did not contribute to the ITT analysis: 8 AEs; 10 lack of efficacy (whereof 8 were allocated to topiramate); 2 moved |
| Selective reporting (reporting bias) | Low risk | No suspicion of selective reporting of outcomes, time points, or analyses |