Cai Zijie, Meng ChunXue, Wang Fei, Tang ChunZhi, Zhang Jing, Zhang Qian, Guo Bin
Guangdong International Clinical Research Center of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.
Ningxia Medical University, Yinchuan City, Ningxia Hui Autonomous Region, China.
JMIR Res Protoc. 2025 Apr 21;14:e63933. doi: 10.2196/63933.
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.
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.
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.
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.
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.
Chinese Clinical Trial Registry ChiCTR2500095634; https://www.chictr.org.cn/historyversionpubEN.html?regno=ChiCTR2500095634.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/63933.
变应性鼻炎（AR）是一种鼻黏膜非感染性慢性炎症性疾病，主要特征为鼻痒、喷嚏、鼻塞和流涕。它由免疫球蛋白E（IgE）介导。AR是全球最常见的变应性疾病之一，影响全球10%至20%的人口，某些地区患病率甚至高达50%，构成了一个全球性健康问题。自20世纪60年代以来，AR的患病率一直在上升，近年来显著增加。目前，现代医学包括脱敏治疗、使用抗过敏药物、抗组胺药、激素及其他治疗方法，可以改善症状或调节免疫系统。然而，短期和长期疗效仍然有限，因为治疗停止后症状往往复发，长期使用药物会产生毒性和副作用。
穴位埋线（ACE）疗法在中国广泛用于治疗AR。据报道，ACE疗法在控制AR症状方面有效，但证据存在方法学局限性。因此，我们设计了一项平行组、随机对照、多中心、安慰剂对照、单盲试验，以评估ACE疗法治疗AR的疗效和安全性。
本研究将在中山大学附属第三医院、宁夏中医研究院和山西中医药大学附属医院进行一项平行组、患者盲法、安慰剂对照的随机对照试验。试验包括为期4周的治疗期以及3个月的随访。在提供书面知情同意书后，符合条件的参与者将按1:1的比例随机分为2组之一：接受治疗的ACE组和假ACE组。两组均接受常规氯雷他定治疗。
资金于2022年1月开始。该研究于2025年2月1日启动，将于2026年2月结束。患者招募已经开始，研究结果将于2026年3月公布。
我们预计这项研究将为ACE治疗AR的疗效提供重要见解，并为该领域未来的研究基础生成有力数据。
中国临床试验注册中心ChiCTR2500095634；https://www.chictr.org.cn/historyversionpubEN.html?regno=ChiCTR2500095634。
国际注册报告识别码（IRRID）：PRR1-10.2196/63933。
