Safety and onset time of modified Yupingfeng nasal spray versus mometasone furoate nasal spray on house dust mites-induced moderate to severe allergic rhinitis: A prospective, multicenter, randomized, open-label, parallel-group clinical trial

IF 4.8 2区医学 Q1 CHEMISTRY, MEDICINAL

Journal of ethnopharmacology Pub Date : 2025-03-01 DOI:10.1016/j.jep.2025.119574

Huan Wang , Ting Liu , Chao Liao , Fangqi Liang , Li Tian

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Abstract

Ethnopharmacological relevance

House dust mite (HDM)-induced allergic rhinitis (AR) is a significant global health issue, leading to considerable illness and disability worldwide. In traditional Chinese medicine, Modified Yupingfeng Nasal Spray (MYN) is believed to support defense systems, and regulate immune defense systems.

Aim of the study

Previous research has shown that both MYN and mometasone furoate nasal spray (MFN) can alleviate symptoms of HDM-induced AR. However, the safety and onset time of MYN compared to MFN for treating HDM-induced AR remain unclear. This study aimed to explore the onset time, safety, and potential mechanisms of MYN and MFN in the treatment of HDM-induced AR.

Methods

In a multicenter, randomized, open-label, parallel-arm trial, 207 patients with AR who tested positive for HDMs allergens (≥2+) were randomly assigned to receive either MYN or MFN treatment. The primary endpoint was the onset time of AR remission. Additionally, 9 patients were randomly selected from each group to investigate potential mechanisms.

Results

Compared to MFN (12.05 ± 1.07 days), MYN (21.56 ± 1.92 days) had a slower onset time in controlling AR symptoms. However, there was no significant difference in cumulative remission of AR between MYN and MFN after 77 days of treatment. At the end of the study, no significant difference in disease control rates was observed between MYN (89.00%) and MFN (96.04%) (P > 0.05). MYN treatment significantly increased PTEN mRNA levels in nasal mucosal epithelial cells and serum IL-10, while reducing NF-κΒ and TSLP levels in nasal lavage fluid, as well as serum IL-6 and TNF-α (P < 0.05).

Conclusions

Both MYN and MFN effectively reduce AR symptoms; however, MFN acts more quickly than MYN in relieving these symptoms, while MYN is associated with fewer side effects. The therapeutic effects of MYN may be linked to the regulation of the PTEN/NF-κB/TSLP signaling pathway.

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来源期刊

Journal of ethnopharmacology 医学-全科医学与补充医学

CiteScore

10.30

自引率

5.60%

发文量

967

审稿时长

77 days

期刊介绍： The Journal of Ethnopharmacology is dedicated to the exchange of information and understandings about people''s use of plants, fungi, animals, microorganisms and minerals and their biological and pharmacological effects based on the principles established through international conventions. Early people confronted with illness and disease, discovered a wealth of useful therapeutic agents in the plant and animal kingdoms. The empirical knowledge of these medicinal substances and their toxic potential was passed on by oral tradition and sometimes recorded in herbals and other texts on materia medica. Many valuable drugs of today (e.g., atropine, ephedrine, tubocurarine, digoxin, reserpine) came into use through the study of indigenous remedies. Chemists continue to use plant-derived drugs (e.g., morphine, taxol, physostigmine, quinidine, emetine) as prototypes in their attempts to develop more effective and less toxic medicinals.