Summary of findings 1. Norethisterone compared to placebo for seizures in catamenial epilepsy.
Norethisterone compared to placebo for seizures in catamenial epilepsy | ||||||
Patient or population: women with seizures due to catamenial epilepsy Settings: outpatients Intervention: norethisterone Comparison: placebo | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Placebo | Norethisterone | |||||
Seizure freedom Follow‐up: NA |
Outcome not reported. | NA | ||||
Responder rate Follow‐up: NA |
Outcome not reported. | NA | ||||
Change in seizure frequency Follow‐up: up to 14 months |
Neither of the studies showed any significant differences between treatments in terms of seizure frequency. | NA | 24 (2 cross‐over studies) | ⊕⊝⊝⊝
very low1 |
1 of the studies also considered tonic‐clonic and complex‐partial catamenial seizures separately. No significant differences were found between treatments by seizure type. | |
Number of withdrawals from the study Follow‐up: up to 14 months |
Neither of the studies reported any treatment withdrawals. | NA | 24 (2 cross‐over studies) | ⊕⊝⊝⊝
very low1 |
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Adverse events Follow‐up: up to 14 months |
4 "mild" types of adverse event considered to be related to the trial medication were reported: irregularities in menstrual cycle (5 women), facial rash (1 woman), headaches (2 women), mild swelling of hands and feet (1 woman), and bloated feeling (1 woman). | NA | 15 (1 cross‐over study) | ⊕⊝⊝⊝
very low1 |
It is assumed that these events occurred whilst women were taking norethisterone (and no events were reported in the placebo group), but this is not explicitly stated. | |
Quality of life Follow‐up: NA |
Outcome not reported. | NA | ||||
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; NA: not applicable | ||||||
GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. |
1Downgraded three times due to serious imprecision and risk of bias: the two included studies used a cross‐over design, had a very small sample size, and reported limited information regarding study design and numerical results.