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
Abstract
ABSTRACT 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 =…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 174 participants or records.
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