Effect of budesonide oral suspension on dysphagia and esophageal inflammation in eosinophilic esophagitis: a systematic review and meta-analysis

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Abstract

BACKGROUND: Eosinophilic esophagitis (EoE) is a chronic, immune-mediated esophageal disease defined by the combination of clinical symptoms of esophageal dysfunction and histological evidence of eosinophilic infiltration (≥15 eosinophils per high-power field [eos/hpf]) once secondary causes have been excluded. Tissue remodelling and impaired motility cause dysphagia and food impaction. Budesonide oral suspension (BOS) is a topical corticosteroid formulated to enhance mucosal contact and reduce inflammation. This systematic review and meta-analysis evaluated the efficacy and safety of BOS in improving dysphagia and achieving histological remission in EoE. METHODS: Following the PRISMA 2020 statement, PubMed, Scopus, Web of Science, and EMBASE were searched from inception to October 14, 2024, with an update verified up to the date of submission. Randomized controlled trials (RCTs) comparing BOS (1-2 mg twice daily) versus placebo in pediatric or adult EoE patients treated for ≥12 weeks were included. The primary outcome was histologic remission (<15 eos/hpf). Secondary outcomes included endoscopic findings (Eosinophilic Esophagitis Endoscopic Reference Score, EREFS), patient-reported symptom severity (assessed with validated symptom instruments, including the Dysphagia Symptom Questionnaire, DSQ), and treatment-emergent adverse events. Random-effects meta-analyses were performed using the Paule-Mandel estimator, and certainty of evidence was graded with GRADE. Mean difference (MD; the average between-group difference in the unit of the outcome) and odds ratio (OR) were reported with 95% confidence intervals (CI). RESULTS: Four RCTs (n = 523) met the inclusion criteria. BOS significantly improved histologic outcomes versus placebo (MD = -54.62 eos/hpf; 95% CI -68.19 to -41.05; I2 = 34.3%). Endoscopic severity improved (MD = -1.68; 95% CI -3.09 to -0.26). Patient-reported symptom severity also improved (pooled MD = -3.29 points; 95% CI -6.17 to -0.40), although the contributing trials used different validated symptom instruments, so this estimate reflects a composite symptom-severity effect. Treatment-emergent adverse events, mainly oropharyngeal/esophageal candidiasis, did not differ meaningfully between groups; serious adverse events were rare. CONCLUSIONS: BOS effectively reduces esophageal inflammation and alleviates dysphagia in EoE, supporting its use as a first-line topical therapy. The novel contribution of this synthesis is a strictly homogenous BOS-versus-placebo evidence base in which formulation, dose range, and follow-up are aligned across the four RCTs, complementing-rather than duplicating-broader meta-analyses that pooled heterogeneous budesonide preparations. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD42025631228, identifier CRD4202525631228.

Abstract as published, via PubMed.