Cleland 1995.
Study characteristics | ||
Methods | Double‐blind randomised controlled trial, cross‐over design. | |
Participants | 15 female participants with documented catamenial exacerbation of epilepsy. Age, epilepsy duration, and seizure frequency at baseline of participants not reported. |
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Interventions | 6 months of either norethisterone (0.35 mg daily) or placebo treatment, followed by 2‐month wash‐out followed by 6 months of the other treatment; usual medication was continued. | |
Outcomes | Side effects. Mean menstrual cycle length. Number of seizures outside of "key days". Exacerbation of seizure frequency outside of "key days". |
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Funding | Not stated. | |
Conflict of Interest | Not stated. | |
Notes | Study reported as an abstract only. Very limited information regarding design reported. | |
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, and a placebo was used. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Inconsistent information throughout the abstract: 5 women studied, 8 out of 14 women had adverse events, but no women withdrew from the study. Unclear how many women were studied. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information reported in the abstract to permit a judgement. |
Other bias | Unclear risk | Insufficient information reported in the abstract to permit a judgement. |