Efficacy And Safety of Acupoint Catgut Embedding for Perennial Allergic Rhinitis: Protocol for a Randomized Clinical Trial.

Abstract

Background: Allergic rhinitis (AR) is a noninfectious chronic inflammatory disease of the nasal mucosa characterized mainly by itching, sneezing, nasal congestion, and rhinorrhea. It is mediated by immunoglobulin E (IgE). AR is one of the most common allergic diseases globally, affecting 10% to 20% of the population worldwide, with some regions even reaching rates as high as 50%, posing a global health issue. The prevalence of AR has been increasing since the 1960s, with a significant increase in recent years. At present, modern medicine-including desensitization therapy, the use of antiallergic drugs, antihistamines, hormones, and other treatments-can improve symptoms or regulate the immune system. However, both short- and long-term efficacy remain limited, as symptoms often recur after treatment cessation, and long-term drug use is associated with toxicity and side effects.

Objective: Acupoint catgut embedding (ACE) therapy is widely used to treat AR in China. ACE therapy has been reported to be effective in managing the symptoms of AR, but the evidence faces methodological limitations. Therefore, we designed a parallel-arm, randomized controlled, multicentered, placebo-controlled, and single-blinded trial to evaluate the efficacy and safety of ACE therapy for AR.

Methods: This study will be a parallel-group, patient-blind, placebo-controlled randomized controlled trial conducted in the Third Affiliated Hospital of Sun Yat-sen University, Ningxia Chinese Medicine Research Center, and the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine. The trial consists of a 4-week treatment period, along with a 3-month follow-up. After providing written informed consent, eligible participants will be randomized at a ratio of 1: 1 into one of 2 groups: the ACE group receiving treatment and the sham ACE group. Both groups will receive conventional loratadine treatment.

Results: The funding began in January 2022. The study was initiated on February 1, 2025, and will end in February 2026. Patient recruitment has already started, and the study results will be released in March 2026.

Conclusions: We expect that this research will provide important insights into the efficacy of ACE treatment for AR and generate robust data for the foundation of future research in this field.

Trial registration: Chinese Clinical Trial Registry ChiCTR2500095634; https://www.chictr.org.cn/historyversionpubEN.html?regno=ChiCTR2500095634.

International registered report identifier (irrid): PRR1-10.2196/63933.