Clinical and translational allergy · 2025
A Multicenter, Randomized, Controlled Clinical Trial on the Efficacy and Safety of Eucalyptol, Limonene, and Pinene Enteric Capsules in the Treatment of Chronic Rhinosinusitis With Nasal Polyps Postoperatively.
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Sima Yutong, Liu Jianfeng, Liu Jinfeng, Zheng Gang, Yang Yi, Peng Xiaolin, Qi Yan, Wang Xiaowei, Zhao Yu, Wang Yanjun, Zhao Penglong, Zhao Jinming, Zhang Yuan, Zheng Ming, Liu Chengyao, Song Xiaohong, Dong Yi, Gong Xia, Lv Wei, Wang Zhenlin, Wang Xiangdong, Zhang Luo
Аннотация
BACKGROUND: Eucalyptol, limonene, and pinene enteric capsules (ELP) are typical mucoactive drugs used in chronic rhinosinusitis with nasal polyps (CRSwNP). However, reliable evidence regarding its efficacy in this population remains limited. This study aimed to evaluate the clinical efficacy and safety of ELP, particularly on nasal ciliary function and inflammatory biomarkers.
METHODS: This prospective, randomized, controlled, multicenter clinical study enrolled CRSwNP patients who underwent endoscopic sinus surgery (ESS). Participants were randomly assigned at a 1:2 ratio to the intranasal corticosteroid (INCS) group or the ELP + INCS group. Clinical outcomes were assessed over 12 weeks using sinus computed tomography, nasal endoscopy, saccharin tests (STs) and the 22-item sinonasal outcome tests (SNOT-22). Local inflammation in nasal secretions were quantified via a Luminex assay, and adverse effects (AEs) was monitored throughout the study period.
RESULTS: A total of 174 CRSwNP patients were included in the final analysis. Compared to the INCS group, the ELP + INCS group demonstrated significantly greater improvements in Lund-Mackay score (LMS) and Lund-Kennedy score (LKS) (p = 0.029 and 0.025, respectively). A higher proportion of patients in the ELP + INCS group also showed improvement in the runny nose score (weeks 8 and 12), cough score (week 4), and frustration score (week 8). Furthermore, STT was significantly shorter in the ELP + INCS group at week 4 (p = 0.015). Subgroup analysis revealed that the ELP + INCS group had significantly lower concentrations of granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-4, granulocyte colony-stimulating factor (G-CSF) and thrombopoietin (Tpo) compared to the INCS group. No significant difference was observed in the incidence of AEs between the two groups.
CONCLUSION: The combination of ELP and INCS represents an effective and well-tolerated treatment strategy for patients with CRSwNP following endoscopic sinus surgery.
TRIAL REGISTRATION: The trial was registered with the Chinese Clinical Trial Registry (www.chictr.org.cn; registration number ChiCTR2200055224).
METHODS: This prospective, randomized, controlled, multicenter clinical study enrolled CRSwNP patients who underwent endoscopic sinus surgery (ESS). Participants were randomly assigned at a 1:2 ratio to the intranasal corticosteroid (INCS) group or the ELP + INCS group. Clinical outcomes were assessed over 12 weeks using sinus computed tomography, nasal endoscopy, saccharin tests (STs) and the 22-item sinonasal outcome tests (SNOT-22). Local inflammation in nasal secretions were quantified via a Luminex assay, and adverse effects (AEs) was monitored throughout the study period.
RESULTS: A total of 174 CRSwNP patients were included in the final analysis. Compared to the INCS group, the ELP + INCS group demonstrated significantly greater improvements in Lund-Mackay score (LMS) and Lund-Kennedy score (LKS) (p = 0.029 and 0.025, respectively). A higher proportion of patients in the ELP + INCS group also showed improvement in the runny nose score (weeks 8 and 12), cough score (week 4), and frustration score (week 8). Furthermore, STT was significantly shorter in the ELP + INCS group at week 4 (p = 0.015). Subgroup analysis revealed that the ELP + INCS group had significantly lower concentrations of granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-4, granulocyte colony-stimulating factor (G-CSF) and thrombopoietin (Tpo) compared to the INCS group. No significant difference was observed in the incidence of AEs between the two groups.
CONCLUSION: The combination of ELP and INCS represents an effective and well-tolerated treatment strategy for patients with CRSwNP following endoscopic sinus surgery.
TRIAL REGISTRATION: The trial was registered with the Chinese Clinical Trial Registry (www.chictr.org.cn; registration number ChiCTR2200055224).