Korean medicine registry for allergic rhinitis in real-world settings (KOREA-R): a multicenter registry protocol.

Abstract

Background: Allergic rhinitis is a prevalent immune disorder with a significant impact on quality of life and socioeconomic burden. Korean Medicine treatments such as herbal medicine and acupuncture are widely utilized for allergic rhinitis due to clinical effectiveness and patient preferences. In particular, herbal decoctions, a key component of Korean Medicine treatment for allergic rhinitis, offer personalized treatment but pose challenges for randomized controlled trials due to the difficulty of placebo development. This study aims to establish a registry utilizing real-world data (RWD) on Korean Medicine treatment for allergic rhinitis, focusing on the effectiveness, safety, and cost-effectiveness of herbal decoctions in clinical practice.

Methods: The KOrean medicine REgistry for Allergic rhinitis in Real-world settings (KOREA-R) aims to enroll 400 patients with allergic rhinitis receiving Korean Medicine treatment at two Korean Medicine hospitals from February 2025 to June 2028. Patients will be examined in three visits at 2-week intervals, followed by two additional online follow-ups at 6 and 12 months after week 4. RWD on symptom severity, quality of life, treatment administration and compliance, adverse events, and laboratory blood tests will be collected. Participation is voluntary, with no restrictions on treatment types or dosages. Statistical analyses, including propensity score matching and difference-in-difference, will be used to evaluate the effectiveness, safety, and cost-effectiveness of Korean Medicine treatment, particularly herbal decoctions. Data management ensures confidentiality and quality through a validated electronic data capture system and regular monitoring.

Conclusion: The findings of KOREA-R will provide insights into the effectiveness and safety of Korean Medicine treatment for allergic rhinitis, with a focus on herbal decoctions tailored to individual patient symptoms and pattern identifications. Additionally, by systematically collecting RWD for multidimensional analysis, KOREA-R will offer valuable information on the cost-utility and cost-effectiveness of herbal decoctions for both patients and healthcare policymakers.

Study registration: Clinical Research Information Service, KCT0010133 (Registration date: January 13, 2025).