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. 2021 Sep 16;2021(9):CD013225. doi: 10.1002/14651858.CD013225.pub3

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.
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".
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.