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

Researchers in South Korea are conducting a large study to determine whether combining Korean medicine (including acupuncture and herbal treatments) with conventional Western medicine works better and costs less than using either approach alone for treating primary headaches, including migraines and tension-type headaches. This study is important because headaches are extremely common worldwide and cause significant disability and economic burden, yet evidence about combining different treatment approaches remains limited. The study will enroll 312 adult patients with primary headache disorders across multiple hospitals participating in South Korea's national collaborative treatment pilot project. Participants will choose to receive either collaborative treatment (combining Western medications with Korean medicine therapies like acupuncture, pharmacopuncture, and herbal medicine) or usual care (treatment with only Western or Korean medicine alone). Researchers will track headache frequency, pain levels, quality of life, and treatment costs over 12 weeks to determine which approach provides better outcomes and value. The study emphasizes real-world effectiveness, meaning it examines how these treatments work in everyday clinical practice rather than in highly controlled experimental settings. Data collection began in August 2025 and will continue through December 2027, with results expected in 2028. For patients considering acupuncture for headaches, this research may eventually provide stronger evidence about whether combining acupuncture with conventional treatments offers additional benefits. The findings could help patients and healthcare providers make more informed decisions about headache treatment options and may influence health policy regarding integrated care approaches. If you're considering acupuncture for headaches, seek a licensed practitioner certified by your state's acupuncture board or a qualified physician acupuncturist.

This multicenter prospective observational study evaluates the clinical effectiveness and cost-effectiveness of collaborative Korean medicine (KM) and Western medicine (WM) treatment versus usual care for primary headache disorders in real-world settings. The study will enroll 312 adults (age ≥19 years) with primary headache disorders across South Korean hospitals participating in the national collaborative treatment pilot project. The collaborative intervention integrates WM pharmacotherapy with KM modalities including acupuncture, pharmacopuncture, and herbal medicine, compared against monodisciplinary care. Primary outcomes include monthly headache days, numeric rating scale scores, Headache Impact Test results, and quality-adjusted life years (QALYs) assessed at baseline, 6 weeks, and 12 weeks. Economic evaluation will calculate incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. Both intention-to-treat and per-protocol analyses will be conducted. This protocol-stage study, funded by South Korea's Ministry of Health and Welfare with data collection ongoing through December 2027, aims to generate robust real-world evidence addressing current gaps in integrative headache management and informing health policy decisions regarding collaborative treatment models.