Lee Hye-Yoon, Kang Hyung-Won, Kim NamKwen, Hyun Eun-Hye, Seo Joo-Hee, Lyu Yeoung-Su, Jung In Chul, Kim Geun-Woo, Park Bora, Choi Sung-Youl, Kim Hye-Won, Kim Hyun-Min
Pusan National University Korean Medicine Hospital, Yangsan-si, Gyeongsangnam-do Wonkwang University Sanbon Hospital, Gunpo-si, Gyeonggi-do School of Korean medicine, Pusan National University, Yangsan-si, Gyeongsangnam-do National Medical Center, Jung-gu, Seoul Department of Korean Neuropsychiatry Medicine, College of Korean Medicine, Wonkwang University, Iksan-si, Jeollabuk-do Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University, Daejeon Department of Neuropsychiatry, Dongguk University Bundang Oriental Hospital, Seongnamsi, Gyeonggi-do Gwangju Oriental Hospital of Wonkwang University, Nam-gu, Gwangju Department of Neuropsychiatry, College of Korean Medicine, Gachon University, Seongnam-si, Gyeonggi-do, Republic of Korea.
Medicine (Baltimore). 2018 Aug;97(35):e12098. doi: 10.1097/MD.0000000000012098.
South Korea has a dual medical system comprising conventional Western medicine (WM) and traditional Korean medicine (KM), which has yielded both positive results (increased opportunity to choose medical care) and negative results (increased medical costs). Thus, the Ministry of Health and Welfare has been performing a pilot project to evaluate this collaborative system in the real clinical situation. As treatment of dementia requires a social approach, the Korean government aims to strengthen the role of the national health care system to reduce the burden of dementia. The aim of this study was to evaluate the clinical - and cost-effectiveness of collaborative KM and WM treatment in patients with dementia or mild cognitive impairment (MCI) in Korea.
METHOD/DESIGN: In total, 180 patients with dementia or MCI will be recruited and will undergo monthly check-up for 12 weeks. Information regarding demographic characteristics, baseline disease-related data, and outcomes related to cognitive function and quality of life will be obtained. For data analysis, the patients will be classified into 2 groups using a comparative observational study design: the sole treatment group, which will receive either WM or KM alone, and the collaborative treatment group, which will receive both WM and KM.
The treatment of dementia/MCI in South Korea will be studied in the real world during the pilot project. There will be no limitations on the type of treatment or the specific treatment method. Examining the clinical- and cost- effectiveness of the different methods will supply information for building an optimal medical system for the treatment of dementia/MCI.
The protocol for this study has been registered at the clinical research information service (CRIS: KCT0002868).
韩国拥有一个由传统西医（WM）和传统韩医（KM）组成的二元医疗体系，这一体系既产生了积极成果（增加了医疗选择机会），也带来了消极结果（增加了医疗成本）。因此，卫生与福利部一直在开展一个试点项目，以在实际临床环境中评估这一协作体系。由于痴呆症的治疗需要社会层面的方法，韩国政府旨在加强国家医疗保健系统的作用，以减轻痴呆症负担。本研究的目的是评估在韩国，韩医与西医协作治疗对痴呆症或轻度认知障碍（MCI）患者的临床疗效和成本效益。
方法/设计：总共将招募180名痴呆症或MCI患者，并对其进行为期12周的每月一次检查。将获取有关人口统计学特征、基线疾病相关数据以及与认知功能和生活质量相关的结果的信息。为了进行数据分析，将采用比较观察性研究设计将患者分为两组：单一治疗组，将单独接受西医或韩医治疗；协作治疗组，将同时接受西医和韩医治疗。
在试点项目期间，将在现实世界中研究韩国对痴呆症/MCI的治疗情况。对治疗类型或具体治疗方法将不设限制。研究不同方法的临床疗效和成本效益将为构建治疗痴呆症/MCI的最佳医疗体系提供信息。
本研究方案已在临床研究信息服务（CRIS：KCT0002868）注册。
