Bae Kyeore, Park Minjung, Yi Junhyeok
National Agency for Korean Medicine Innovative Technologies Development, National Institute for Korean Medicine Development, Seoul, Republic of Korea.
College of Korean Medicine, Gachon University, Seongnam, Republic of Korea.
Integr Med Res. 2025 Sep;14(3):101152. doi: 10.1016/j.imr.2025.101152. Epub 2025 May 21.
Despite its high prevalence, dysmenorrhea is an underestimated gynecological disorder. To enhance the service coverage, the Pilot Project for Expanding National Health Insurance (NHI) Coverage to Herbal Decoctions (HDs) was implemented in the Republic of Korea from November 2020. This study aimed to assess the effectiveness and safety of HDs for dysmenorrhea at a nationwide level. Additionally, its impact on accessibility was explored.
This retrospective observational study used claims data from the pilot project (November 1, 2020, to April 28, 2024). A linear mixed-effects model was used to estimate symptom improvement during the HD exposure period. Time series data decomposition and structural change points detection were performed using NHI statistics on dysmenorrhea patient counts for those who received medical services between 2014 and 2023.
Among 39,574 participants, a descriptive analysis of 7016 suggested a tendency to receive HD treatment for moderate-to-severe symptoms. Effectiveness analysis demonstrated that HD significantly reduced symptom severity over time (β = -0.072, < 0.001). Adverse events were reported by 0.58 % of the patients, mostly involving gastrointestinal symptoms. Following the initiation of the pilot project, a significant increase in the number of patients with dysmenorrhea receiving traditional Korean medicine (TKM) services was observed.
The nationwide pilot project showed clinical effectiveness and a manageable safety profile of HDs for dysmenorrhea. The universal health coverage initiative appeared to have improved the accessibility of TKM services for managing dysmenorrhea. Further robust research utilizing nationwide real-world data is required to validate these findings.
尽管痛经患病率很高,但它仍是一种被低估的妇科疾病。为了提高服务覆盖率,大韩民国于2020年11月实施了将国家健康保险(NHI)覆盖范围扩大至中药汤剂(HDs)的试点项目。本研究旨在评估HDs在全国范围内治疗痛经的有效性和安全性。此外,还探讨了其对可及性的影响。
这项回顾性观察研究使用了试点项目(2020年11月1日至2024年4月28日)的理赔数据。采用线性混合效应模型估计HD暴露期间症状的改善情况。利用2014年至2023年期间接受医疗服务的痛经患者的NHI统计数据,进行了时间序列数据分解和结构变化点检测。
在39574名参与者中,对7016名的描述性分析表明,中重度症状患者有接受HD治疗的倾向。有效性分析表明,HD随着时间的推移显著降低了症状严重程度(β = -0.072,P < 0.001)。0.58%的患者报告了不良事件,主要涉及胃肠道症状。试点项目启动后,观察到痛经患者接受韩医(TKM)服务的人数显著增加。
全国性试点项目显示了HDs治疗痛经的临床有效性和可控的安全性。全民健康覆盖倡议似乎改善了TKM服务在管理痛经方面的可及性。需要利用全国真实世界数据进行进一步的有力研究来验证这些发现。