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Journal of Traditional Chinese Medicine ›› 2025, Vol. 45 ›› Issue (4): 829-835.DOI: 10.19852/j.cnki.jtcm.20241226.001

• Original Articles • Previous Articles     Next Articles

Efficacy and safety of Tuomin Zhiti decoction (脱敏止嚏汤) on patients with seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial

ZHAO Weibo1, WANG Yaqi2, KONG Lingyao3, WANG Tianyi4, ZHAO Haihong1, ZHANG Ying3, LUO Bin1, WANG Ji1(), WANG Qi1()   

  1. 1 National Institute of TCM Constitution and Preventive Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
    2 College of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou 310053, China
    3 Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
    4 Beijing University of Chinese Medicine International School, Beijing 100029, China
  • Received:2024-08-22 Accepted:2024-12-12 Online:2025-08-15 Published:2024-12-26
  • Contact: WANG Ji,WANG Qi
  • About author:WANG Qi, National Institute of TCM Constitution and Preventive Medicine, Beijing University of Chinese Medicine, Beijing 100029, China. wangqi710@126.com，Telephone: +86-17801016686
    WANG Ji, National Institute of TCM Constitution and Preventive Medicine, Beijing University of Chinese Medicine, Beijing 100029, China. doctorwang2009@126.com;
  • Supported by:
    Fundamental Research Funds for the Central Universities(2023-JYB-JBZD-009);High level Key Discipline of National Administration of Traditional Chinese Medicine-Traditional Chinese Constitutional Medicine(zyyzdxk-2023251);General program of National Natural Science Foundation of China: Study on the Mechanism of "the Simultaneous Prevention of Different Diseases" of Allergic Constitution Regulating Formula based on DNA Trap Mediated Eosinophil-Derived Dendritic Cells Cell Crosstalk(82174243);General Project of Beijing Natural Science Foundation: Study on the Mechanism of Guominkang for Treating Allergic Rhinitis through Regulating Body Constitution based on Vacuolating Cytotoxin A-mediated Eosinophil-derived Dendritic Cell Cell immune microenvironment(7242227)

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Abstract:

OBJECTIVE: To evaluate the clinical efficacy and safety of Tuomin Zhiti decoction (脱敏止嚏汤, TZD) in the short-term treatment of seasonal allergic rhinitis (SAR).

METHODS: This study is a randomized, double-blind placebo-controlled, and single-center clinical trial. In April 2021, during the spring pollen season in Beijing, 94 SAR patients aged 19-60 years were randomized (1:1 ratio) to receive two weeks of TZD or placebo. The primary outcomes were the change of Total Nasal Symptom Score (TNSS) and Total Ocular Symptom Score (TOSS) from baseline to the end of treatment. Secondary outcomes were the changed score of the mini Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Rescue Medication Score (RMS), and Patient Global Impression of Change (PGIC). All adverse events were recorded and evaluated by two senior physicians.

RESULTS: TZD significantly reduced both the total nasal symptom scores and total ocular symptom scores compared to scores at baseline, while the placebo group showed an increasing trajectory in both symptom scores. Compared to the placebo group, the TZD group also showed a greater improvement in the quality of life, scores of RMS, nasal and eye symptoms scores after TZD treatment (P < 0.001). Most notably, at the end of treatment, the proportion of remission measured by PGIC was significantly higher in the TZD group (82.97%) compared with the placebo group (47.72%, P < 0.001).

CONCLUSION: This study suggested that two weeks of TZD is an effective and safe treatment for SAR patients and spring pollen allergy, TZD could significantly improve the nasal and eye symptoms and improve the quality of life of patients.

Key words: rhinitis, allergic, seasonal, quality of life, Tuomin Zhiti decoction, randomized controlled trial

Cite this article

ZHAO Weibo, WANG Yaqi, KONG Lingyao, WANG Tianyi, ZHAO Haihong, ZHANG Ying, LUO Bin, WANG Ji, WANG Qi. Efficacy and safety of Tuomin Zhiti decoction (脱敏止嚏汤) on patients with seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial[J]. Journal of Traditional Chinese Medicine, 2025, 45(4): 829-835.