Clinical Effectiveness and Cost-Effectiveness of Collaborative Treatment With Korean and Western Medicine for Primary Headache Disorders: Protocol fora Multicenter Prospective Observational Study

Abstract

Background: Primary headache disorders, including migraine and tension-type headache, are among the most prevalent neurological conditions worldwide, significantly contributing to disability and socioeconomic burden. While Western medicine (WM) predominantly focuses on pharmacological symptom management, Korean medicine (KM) emphasizes a holistic, individualized approach using modalities such as acupuncture and herbal medicine. Collaborative treatment, which combines these approaches, has been proposed as an alternative approach; however, robust evidence on its clinical effectiveness and cost-effectiveness remains limited. Objective: This study aims to evaluate the clinical effectiveness and economic value of collaborative treatment compared with usual care (UC) in patients with primary headache disorders in real-world clinical settings. Methods: This prospective, 2-arm, multicenter observational study will assess and compare the clinical effectiveness and economic value of collaborative treatment versus UC alone for patients with primary headache disorders. Adults aged >= 19 years with a primary diagnosis of primary headache disorders visiting participating hospitals under South Korea's national collaborative treatment pilot project will be enrolled. Participants will receive either collaborative treatment (integrating WM pharmacotherapy with KM therapies such as acupuncture, pharmacopuncture, and herbal medicine) or UC (monodisciplinary carewith WM or KM alone) based on informed choice. Clinical and cost-related outcomes will be assessed at baseline and 6 and 12 weeks. Clinical outcomesinclude monthly headache days, the numeric rating scale, the Headache Impact Test, the EQ-5D-5L, and the EuroQol visual analogue scale. The cost-effectiveness evaluation includes the cost per quality-adjusted life year, the incremental cost-effectiveness ratio, and the cost-effectiveness acceptability curve. Both intention-to-treat and per-protocol analyses will be performed. Results: The study protocol was approved by the institutional review boards in July 2025. The study is funded by the Ministry of Health and Welfare, Republic of Korea (grant 202500900001). Participant recruitment commenced in August 2025, aiming to enroll 312 patients across multiple centers. Data collection is currently ongoing and is projected to be completed by December 2027, with results expected to be published in 2028. Conclusions:This study is designed to generate real-world evidence on whether collaborative treatment yields superior clinical outcomesand greater cost-effectiveness compared to UC for primary headache disorders. The findings are expected to address existing evidence gaps by integrating multidimensional clinical and economic measures, supporting informed decision-making for health policy, and contributing to the advancement of collaborative treatment models for headache management within South Korea's medical system and beyond.