Real-World Evidence on Herbal Medicine Prescriptions for Stroke Sequelae in Korean Cohort
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Key Takeaway
Note mixed symptom outcomes in 942 stroke sequelae patients using herbal medicine in this observational cohort study.
This retrospective cohort study utilized nationwide health insurance claims data from Korea to evaluate reimbursed herbal medicine prescriptions. The setting was a nationwide health insurance claims data system. The population consisted of 942 patients diagnosed with sequelae of cerebrovascular disease participating in a pilot program between November 2020 and April 2024. Mean patient age was 73.2 ± 6.0 years.
The intervention involved prescriptions for herbal medicines including Gamidaebo-tang (23.1%), Mangeum-tang (5.8%), and Gagampalmi-hwan (5.1%). Treatment timing data indicated that 57% initiated herbal medicine treatment more than 1 year after stroke onset. There was no external comparator, utilizing a within-subject comparison of first versus last visits. Symptom changes were assessed in 609 patients with paired symptom records. Results showed 19.4% improved, 71.9% stable, and 8.7% worsened.
Safety outcomes were identified from newly added diagnostic codes, but specific adverse event rates were not reported in the abstract. Serious adverse events and discontinuations were not reported. Key limitations include the retrospective analysis design and claims data limitations. The p-value was not reported in the text.
This study aims to generate real-world evidence on safety and effectiveness. However, as an observational study, association cannot be inferred as causation. Clinicians should recognize these findings as preliminary evidence from a national pilot reimbursement program.
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View Original Abstract ↓
IntroductionStroke is a leading cause of long-term disability, and many patients experience persistent neurological and functional impairments after the acute phase. The Korean government launched a national pilot reimbursement program for herbal decoctions to improve access to Korean Medicine (KM) rehabilitation and generate real-world evidence on its safety and effectiveness. This study aimed to analyze the utilization patterns, clinical outcomes, and safety of herbal medicine (HM) among patients with post-stroke sequelae participating in the pilot program.MethodsA retrospective analysis was conducted using nationwide health insurance claims data from the Health Insurance Review and Assessment Service (HIRA). Patients diagnosed with sequelae of cerebrovascular disease (KCD codes I69 or U234) who received reimbursed HM prescriptions between November 2020 and April 2024 were included. Demographic characteristics, prescription patterns, and symptom severity were analyzed. Symptom changes between the first and last visits were assessed using the Wilcoxon signed-rank test, and adverse events (AEs) were identified from newly added diagnostic codes after HM treatment.ResultsA total of 942 eligible patients were analyzed, with a mean age of 73.2 ± 6.0 years. The majority (57%) initiated KM treatment more than 1 year after stroke onset. The most frequently prescribed formulas were Gamidaebo-tang (23.1%), Mangeum-tang (5.8%), and Gagampalmi-hwan (5.1%). Among 609 patients with paired symptom records, 19.4% showed improvement, 71.9% remained stable, and 8.7% worsened (p
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