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Progesterone – What it Meant for Women with Epilepsy

hormonal regulation of menstrual cycle
hormonal regulation of menstrual cycle (Photo credit: Wikipedia)
Dr. Herzog and colleagues from the Progesterone Trial Study Group, a multi-institutional investigator association, presented an analysis of progesterone vs. placebo therapy for women living with epilepsy. This was an important trial, which randomized 294 patients into one of two groups, either using progesterone treatment at 200 mg taken 3 times daily on days 14-28 of one’s treatment cycle, or a placebo treatment plan, in order to assess its impact on seizure treatment. The individuals were randomized 2:1, with two thirds of women receiving progesterone vs. one third receiving the placebo treatment plan. They were also classified as to whether they had seizures in and around their menstrual cycle, or whether their seizures had no relationship to their menstrual cycle. It compared treatments at proportions of more than a 50% response rate, and those that registered more than a 50% seizure reduction in women taking the medication compared to a baseline.

The Results…

The investigators showed that there was no difference in the proportion of responders between progesterone and placebo in either the catamenial (those who have seizures in relationship to the menses) and non-catamenial groups. 

There was a finding that the level of perimenstrual seizure exacerbation was a predictor of responders for progesterone but not placebo. Reductions in seizure frequency correlated with increasing C1 levels for progesterone but not placebo, progressing from 26 to 71% for progesterone vs. 25 to 26% for placebo. A specified clinically important separation between progesterone and placebo responders was realized among 21.4% of women who had a C1 level of greater than 3.

What does this mean?

The researchers concluded that there was no difference in the primary outcome of responder rates between progesterone vs. placebo for either group.
However, there does seem to be some suggestion that the level of perimenstrual seizure exacerbation is a predictor of responder rate with progesterone. Therefore, progesterone may provide clinically important benefit for a small group of women with seizures that are exacerbated by their menstrual cycle. At the end, this study provides significant evidence that cyclic progesterone is ineffective in women with intractable partial epilepsy, yet there are some women who have seizures in and around their period that may benefit from this particular treatment.

Why is this important?

This trial is significant because a small group of women may benefit from this treatment approach.

Obviously, more work needs to be done in order to better identify the women that one should initiate therapy. Fundamentally, this trial is also important because it opens up the possibility of proceeding with progesterone therapy in some women who have seizures related to their menstrual cycle. Clearly risk vs. benefit analysis for the side-effects related to the use of progesterone needs to be considered first; but at least in women there may be an additional option for seizure management.
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