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

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.