Exploratory analysis of real-world use and safety of traditional Korean medicine in pediatric epilepsy: A retrospective observational study

Given the limitations of conventional antiepileptic drugs and the growing need for complementary approaches, traditional Korean medicine has gained interest as a potential treatment option for pediatric and adolescent epilepsy. However, real-world clinical data on its use and safety remain limited. This exploratory study aimed to retrospectively investigate the real-world clinical use and safety of traditional Korean medicine in this population by analyzing medical records from 2 Korean medicine hospitals. A total of 54 patients were included. Demographic characteristics, growth-related indicators, seizure-related indicators, treatment patterns, follow-up duration, antiepileptic drug use, and adverse events were reviewed retrospectively. The mean age at seizure onset was 4.9 ± 4.9 years. Over a mean follow-up duration of 21.6 months, patients had an average of 10.2 ± 13.6 clinical visits and received heterogeneous treatment patterns, including herbal medicine decoction, herbal medicine formulation, and acupuncture. Mean height increased from 122.4 ± 27.6 to 134.0 ± 24.5 cm, and mean weight increased from 29.6 ± 22.1 to 34.9 ± 20.5 kg. Mean seizure frequency decreased from 0.7 ± 1.2 times per day at baseline to 0.2 ± 0.5 times per day during the follow-up period (P = .002). Antiepileptic drug regimens remained largely unchanged during the study period among patients with available medication data. Mild adverse events were reported in 5 patients (nausea, abdominal pain, and diarrhea), all of which resolved without serious complications. This study provides real-world insights into the clinical use and tolerability of traditional Korean medicine treatment in pediatric and adolescent epilepsy. Although therapeutic efficacy cannot be established due to the absence of a control group, these findings offer foundational data to support future hypothesis-driven studies assessing the safety and potential effectiveness of traditional Korean medicine in this population.