Clinical Effectiveness and Cost-Effectiveness of Collaborative Treatment With Korean and Western Medicine for Primary Headache Disorders: Protocol for a Multicenter Prospective Observational Study
Bibliographic record
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 care with WM or KM alone) based on informed choice. Clinical and cost-related outcomes will be assessed at baseline and 6 and 12 weeks. Clinical outcomes include 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 outcomes and 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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/82819.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.039 | 0.039 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.007 | 0.012 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.003 | 0.002 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.023 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".