Evidence map›Paper›PMID 24944264›Full record

Trial reportNeurology2014

Allopregnanolone levels and seizure frequency in progesterone-treated women with epilepsy.

Andrew G Herzog, Cheryl A Frye, Progesterone Trial Study Group

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Treatments for seizures in catamenial (menstrual-related) epilepsy.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Neurosteroids and Seizure Activity.Frontiers in endocrinology · 2020
    Pooled it
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. [Epilepsy with catamenial pattern].Revista de neurologia · 2022
    Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Effects of the Menstrual Cycle on Neurological Disorders.Current neurology and neuroscience reports · 2021
    Review
  18. Treatments for seizures in catamenial (menstrual-related) epilepsy.The Cochrane database of systematic reviews · 2019
    Review
  19. Neurosteroid regulation of GABABrain research · 2019
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Andrew G HerzogFrom the Harvard Neuroendocrine Unit (A.G.H.), Beth Israel Deaconess Medical Center, Boston, MA; and Department of Psychology (C.A.F.), University of Albany-SUNY, NY. aherzog@bidmc.harvard.edu.
Cheryl A FryeFrom the Harvard Neuroendocrine Unit (A.G.H.), Beth Israel Deaconess Medical Center, Boston, MA; and Department of Psychology (C.A.F.), University of Albany-SUNY, NY.
Progesterone Trial Study Group
Beth Israel Deaconess Medical Center · US

Funding

PROGESTERONE THERAPY FOR WOMEN WITH EPILEPSYR01NS039466 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI HERZOG, ANDREW G · 2000 to 2008
$10.5M
NINDS NIH HHS R01 NS39466
6 · The paper itself

Abstract

objectiveTo determine whether allopregnanolone (AP) may mediate seizure reduction in progesterone-treated women with epilepsy.

methodsThe NIH Progesterone Trial compared the efficacy of adjunctive cyclic natural progesterone therapy vs placebo treatment of intractable seizures in 294 subjects, randomized 2:1 to progesterone or placebo, stratified by catamenial vs noncatamenial designation. Treatments were compared on proportions of 50% responders, and changes in seizure frequency from 3 baseline to 3 treatment cycles. Serum AP levels were measured by radioimmunoassay from 155 women with intractable focal-onset seizures who had baseline and treatment-phase midluteal serum samples drawn each cycle for hormone measurements.

resultsThere was no significant correlation between percentage changes in AP levels and seizure frequencies from baseline to treatment for either the catamenial or noncatamenial stratum. There was a significant correlation for the subset of subjects who showed a significantly greater responder rate in the post hoc analysis of the trial, i.e., subjects who had a 3-fold or greater increase in average daily seizure frequency perimenstrually compared with the midfollicular and midluteal phases (C1 ≥ 3: r = -0.442, p = 0.013, and specifically for C1 ≥ 3 progesterone-treated subjects [r = -0.452, p = 0.035], but not other groups [C1 ≥ 3 placebo: r = -0.367; C1 <3 progesterone: r = 0.099; C1 <3 placebo: r = 0.131; p = not significant]).

conclusionsThe findings support AP as a mediator of seizure reduction in progesterone-treated women who have a substantial level of perimenstrually exacerbated seizures.

Indexed as

AnticonvulsantsEpilepsyFemaleHumansMenstrual CyclePregnanoloneProgesteroneRadioimmunoassaySeizuresTreatment OutcomeAnticonvulsantsPregnanoloneProgesterone

Identifiers

PMID24944264
PMCPMC4115601
OpenAlexW2022764608

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.