Clinical Effectiveness and Cost-Effectiveness of Collaborative Treatment With Korean and Western Medicine for Primary Headache Disorders: Protocol for a 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 care with WM or KM alone) based on…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 312 participants or records.
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