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A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III clinical trial to assess the efficacy and safety of Yuping Tongqiao tablets in the treatment of persistent allergic rhinitis

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机构: [1]Capital Med Univ, Beijing Tradit Chinese Med Hosp, Beijing 100010, Peoples R China [2]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Wuhan 430030, Peoples R China [3]Jiangxi Univ Tradit Chinese Med, Affiliated Hosp, Nanchang 330006, Peoples R China [4]Tonghua Cent Hosp, Tonghua 134001, Peoples R China [5]Tianjin Union Med Ctr, Tianjin 300192, Peoples R China [6]Ankang Tradit Chinese Med Hosp, Ankang 725000, Peoples R China [7]Shandong Univ, Qilu Hosp, Jinan 250012, Peoples R China [8]Cangzhou Cent Hosp, Cangzhou 061001, Peoples R China [9]Zhongshan Tradit Chinese Med Hosp, Zhongshan 528400, Peoples R China [10]Jiangsu Prov Hosp Integrat Chinese & Western Med, Nanjing 210029, Peoples R China [11]Xiamen Tradit Chinese Med Hosp, Xiamen 361000, Peoples R China [12]Hunan Univ Chinese Med, Hosp 1, Changsha 410007, Peoples R China [13]Shandong Univ Tradit Chinese Med, Affiliated Hosp, Jinan 250355, Peoples R China [14]Zhangjiagang Tradit Chinese Med Hosp, Zhangjiagang 215600, Peoples R China [15]Chongqing Yongchuan Dist Hosp Tradit Chinese Med, Chongqing 402160, Peoples R China [16]Fourth Hosp Changsha, Changsha 410002, Peoples R China [17]Univ TCM, Hosp Chengdu, Chengdu 610075, Peoples R China [18]Shaoyang Univ, Affiliated Hosp 1, Shaoyang 422001, Peoples R China [19]Yunnan Prov Hosp Tradit Chinese Med, Kunming 650021, Peoples R China [20]Xuzhou Med Univ, Affiliated Hosp, Xuzhou 221002, Peoples R China [21]Yantai Yuhuangding Hosp, Yantai 264000, Peoples R China [22]Yangzhou Univ, Affiliated Hosp, Yangzhou 225001, Peoples R China [23]Nanchang Univ, Affiliated Hosp 1, Nanchang 330006, Peoples R China [24]Henan Prov Peoples Hosp, Zhengzhou 450003, Peoples R China [25]Beijing Univ Chinese Med, Dongzhimen Hosp, Beijing 100700, Peoples R China [26]Wuhan Third Hosp, Wuhan 430060, Peoples R China [27]Univ South China, Affiliated Hosp 1, Hengyang 421001, Peoples R China [28]Beijing Hosp, Beijing 100730, Peoples R China [29]Jiangxi Prov Peoples Hosp, Nanchang 330006, Peoples R China [30]Chenzhou First Peoples Hosp, Chenzhou 423000, Peoples R China [31]Zunyi Med Univ, Affiliated Hosp, Zunyi 563003, Peoples R China [32]Shijiazhuang Yiling Pharmaceut Co Ltd, Shijiazhuang 050035, Peoples R China
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关键词: Allergic rhinitis Yuping Tongqiao tablet Randomized controlled trial

摘要:
Ethnopharmacological relevance: Yuping Tongqiao Tablets is a classic traditional Chinese medicine (TCM) formula commonly employed in China for managing various ailments, especially allergic conditions. Clinical reports indicate its potential as an effective treatment for persistent allergic rhinitis. Nevertheless, there remains a dearth of placebo-controlled studies to definitively establish its safety and efficacy. Aims of the study: Allergic rhinitis (AR) is a global health problem with an annually increasing prevalence and no radical cure to date. This study aimed to evaluate the efficacy and safety of Yuping Tongqiao tablets for the treatment of persistent allergic rhinitis and to provide a basis for using Chinese herbal medicine to treat AR. Materials and methods: This was a multicenter, randomized, double-blind, placebo-controlled study of patients with PAR. A total of 540 patients with PAR were randomly assigned to the test group (n = 360) or the placebo group (n = 180) at a 2:1 ratio. The clinical trial lasted for 4 weeks, evaluating various outcomes including total nasal symptom scores, rhinoconjunctivitis quality of life questionnaire (RQLQ) scores, traditional Chinese medicine (TCM) symptom scores and The incidence of adverse events. Results: A total of 768 participants were enrolled, with 540 randomized and 516 successfully completed the research. The experimental group using Yuping Tongqiao tablets showed a significant reduction in TNSS, with the least squares mean of the average decrease being -2.56 points, compared to -1.74 points in the placebo group (p < 0.01). The experimental group exhibited a higher nasal symptom response rate at 4 weeks, substantial clinical improvements, and notable enhancements in TCM symptoms and RQLQ scores. Treatment efficacy increased with duration, and adverse events were mild-to-moderate and occurred at similar rates in both groups. Conclusion: Yuping Tongqiao tablets have been proven to be an effective and safe medication for the treatment of PAR.

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大类 | 2 区 医学
小类 | 1 区 全科医学与补充医学 1 区 药学 2 区 药物化学 2 区 植物科学
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Q1 CHEMISTRY, MEDICINAL Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Q1 PHARMACOLOGY & PHARMACY Q1 PLANT SCIENCES

影响因子: 最新[2023版] 最新五年平均 出版当年[2024版] 出版当年五年平均 出版前一年[2023版]

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第一作者机构: [1]Capital Med Univ, Beijing Tradit Chinese Med Hosp, Beijing 100010, Peoples R China
通讯作者:
通讯机构: [1]Capital Med Univ, Beijing Tradit Chinese Med Hosp, Beijing 100010, Peoples R China [*1]Beijing Hosp Tradit Chinese Med Afliated Capital M, Dept Otorhinolaryngol Head & Neck Surg, 23 Back Rd Art Gallery, Beijing 100010, Peoples R China
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