Clinical and cost-effectiveness of collaborative treatment with Korean and Western medicine for headache: Protocol for a multicenter prospective observational study (Preprint)

BACKGROUND Headaches are among the most prevalent neurological conditions worldwide, significantly contributing to disability and socioeconomic burden. Conventional treatments for headaches often have limited efficacy and may cause adverse effects, particularly due to medication overuse. Collaborative treatment (CT), which combines Western medicine (WM) and Korean medicine (KM), has been proposed as an alternative approach; however, robust evidence on its clinical and cost-effectiveness remains limited. OBJECTIVE This study aims to evaluate the clinical effectiveness and economic value of CT compared with usual care (UC) in patients with headaches in real-world clinical settings. METHODS This prospective, two-arm, multicenter observational study will assess and compare the clinical effectiveness and economic value of CT versus usual care (UC) alone for patients with headaches. Adults aged 19 years or older with a primary diagnosis of headache visiting participating hospitals under Korea’s national CT pilot project will be enrolled. Participants will receive either CT (WM plus KM) or UC (WM or KM) based on informed choice. Clinical and cost-related outcomes will be assessed at baseline, 6 weeks, and 12 weeks. Clinical outcomes include monthly headache days (MHD), the Numeric Rating Scale (NRS), the Headache Impact Test (HIT-6), the EuroQol-5 Dimensions (EQ-5D-5L), and the EuroQol-Visual Analogue Scale (EQ-VAS). The cost-effectiveness evaluation includes the Cost per QALY (Quality-Adjusted Life Years), the Incremental Cost-Effectiveness Ratio (ICER), and the Cost-Effectiveness Acceptability Curve (CEAC). Both intention-to-treat and per-protocol analyses will be performed. RESULTS As of July 2025, this study protocol has received institutional review board (IRB) approval. Participant recruitment is scheduled to begin in August 2025, aiming to enroll 312 patients across multiple centers. Data collection is projected to be completed by late 2025. CONCLUSIONS This study will generate real-world evidence on whether CT provides superior clinical outcomes and greater cost-effectiveness compared to UC for headaches. The findings will address existing evidence gaps by integrating multidimensional clinical and economic measures, supporting informed decision-making for health policy, and contributing to the advancement of CT models for headache management within Korea’s medical system and beyond. CLINICALTRIAL The study protocol was registered with the Clinical Research Information Service (CRIS) of Korea (https://cris.nih.go.kr/ Registration No: KCT0010812, Date: July 28, 2025)