ArticleSeizure2025
Increased seizure frequency graphs in medication trials: FDA labels vs. peer-review.
Article in Seizure, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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.
Who cites it
1 citing paper in PubMed.
- The Road Not Taken: Misclassifying an Anti-Seizure Medication as a Failure.Annals of clinical and translational neurology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
objectiveAnti-seizure medications (ASMs) typically reduce seizure frequency (SF) in some patients. However, even when the ASM is effective, some patients experience increased SF after initiation largely due to natural fluctuations. Graphical communication of those that experience an increase can vary between trial publications. We assessed the difference in graphical representation of the percentage of patients showing increased SF in ASMs trials between the U.S. Food and Drug Administration (FDA) approved prescribing labels and those in the peer-reviewed literature.
methodsWe searched peer-reviewed literature for the initial publication of randomized clinical efficacy trials referenced in the prescribing labels of FDA-approved ASMs for adjunctive treatment of epilepsy from (2000-2024). We then assessed whether a systematic difference existed in the choice to graphically display the percentage of patients with an increase in SF.
resultsThere were 16 ASMs approved for adjunctive treatment between 2000-2024. There were 43 studies referenced for clinical efficacy in the 16 labels. Peer-reviewed journals included graphs SF increases in 23 % (95 % CI: 12 % to 39 %) compared to FDA-approved labels in 63 % (95 % CI: 35 % to 85 %). The absolute difference in the presence of the graphs was 39 % (95 % CI: 8 % to 65 %) (Chi-squared = 6.359, p-value = 0.012). When text and tables were included peer-review journals presented SF increases in 51 % of the trials (22 out of 43).
conclusionCompared to FDA-approved labels, the peer-reviewed publications of the last 16 FDA-approved ASMs under-informed clinicians about the percentage of patients with increased SF, which may impact informed shared decision-making.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.