Omega-3-Based Nutraceutical Supplementation as Adjunctive Therapy in Adults With Otitis Media With Effusion: A Multicenter, Double-Blind, Randomized Placebo-Controlled Trial
Abstract
Brief Summary - OMENUTS Trial Otitis media with effusion (OME) is a condition in which fluid accumulates in the middle ear, causing conductive hearing loss, ear fullness, tinnitus, and Eustachian tube dysfunction. Although OME is well-recognized in children, it also affects adults, in whom it is frequently under-diagnosed and inadequately treated. No established, well-tolerated pharmacological therapy currently exists for adult OME, and current medical management options - including antihistamines, corticosteroids, and mucolytics - have shown inconsistent efficacy in clinical trials.
Omega-3 polyunsaturated fatty acids and associated nutraceutical compounds have well-documented anti-inflammatory and immunomodulatory properties that are mechanistically relevant to the pathophysiology of OME, which is driven by chronic low-grade mucosal inflammation, Eustachian tube dysfunction, and impaired mucociliary clearance. A nutraceutical combination containing omega-3 fatty acids, Spirulina, magnesium, and vitamin B6 has previously demonstrated efficacy in reducing inflammatory biomarkers and improving clinical outcomes in allergic rhinitis - a condition sharing key pathophysiological features with OME.
The OMENUTS trial is a multicenter, double-blind, randomized placebo-controlled trial designed to evaluate the efficacy of this nutraceutical combination as adjunctive therapy in adults with confirmed OME. The trial is conducted across three tertiary referral centres in Italy: Isola…
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: 501 participants or records.
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