Dana‐Haeri 1983.
Study characteristics | ||
Methods | Double‐blind randomised controlled trial, cross‐over design. | |
Participants | 9 female participants aged 20 to 30 years with catamenial exacerbation occurring in at least 5 of 12 menstrual cycles were included. Participants were either residents at the Chalfont Centre for Epilepsy or outpatients at the National Hospital, London. Epilepsy duration and seizure frequency at baseline not stated. |
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Interventions | 3 treatment periods, each of 4 menstrual cycles, followed by observation for 1 to 2 months:
8 women had been taking either single or combination antiepileptic drug therapy for a long time. 1 woman had discontinued taking carbamazepine and was not taking any antiepileptic drugs. |
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Outcomes | Seizure frequency during 4 menstrual cycles with each treatment. Results presented separately for women with tonic‐clonic seizures and those with complex partial and simple partial seizures. |
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Funding | Not stated. | |
Conflict of Interest | Not stated. | |
Notes | Unclear if there was a wash‐out period between treatment periods (but very limited information provided on study design, therefore study included despite unclear information about wash‐out period). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no further information provided. |
Allocation concealment (selection bias) | Unclear risk | No information reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study described as double‐blind, size‐ and colour‐matched placebos used. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No specific withdrawals reported, but information insufficient to permit a judgement. |
Selective reporting (reporting bias) | Unclear risk | No protocol available, outcomes and statistical methods reported in brief. Limited data reported relating to seizures, and adverse events not reported; unclear if any further information was measured but not recorded. |
Other bias | Unclear risk | Very limited information provided on study design and participant characteristics. Unclear if there was a wash‐out period between treatment periods. Unclear if any other bias may be present. |