Efficacy of Pseudoephedrine and Oxymetazoline in Preventing Otic Barotrauma: A Systematic Review and Meta-Analysis.

BACKGROUND

Otic barotrauma (aerotitis media) occurs when the middle-ear pressure fails to equalize during environmental pressure changes (eg, flying, diving, hyperbaric therapy). Oral pseudoephedrine and intranasal oxymetazoline are commonly used prophylactically, but comparative efficacy and the strength of evidence remain uncertain.

METHODS

We registered a protocol on PROSPERO (CRD420251089756) and conducted a PRISMA-guided systematic review of randomized controlled trials evaluating oral pseudoephedrine or intranasal oxymetazoline for the prevention of otic barotrauma in adults. RevMan 5.4 was used for meta-analysis. Relative risks (RR) with 95% CI were pooled using a fixed-effect generic inverse-variance model.

RESULTS

Four double-blind randomized trials (n=490; conducted 1992-1998) met inclusion. Pseudoephedrine (3 trials) significantly reduced the risk of otic barotrauma versus placebo (RR: 0.55; 95% CI: 0.48-0.66; P <0.00001; I ²=1%), and produced consistent reductions in ear pain (RR: 0.51), blockage (RR: 0.50), and hearing loss (RR: 0.49). Oxymetazoline (2 trials) showed a modest overall effect (RR: 0.75; 95% CI: 0.57-0.99; P =0.05) but inconsistent benefits across individual symptom subgroups and moderate heterogeneity ( I ²=53%). Safety profiles were acceptable in the small trials, although sample sizes were underpowered to detect rare harms.

CONCLUSIONS

In adults, oral pseudoephedrine demonstrated a consistent and clinically meaningful reduction in otic barotrauma in older RCTs; intranasal oxymetazoline showed only modest and variable benefit. The evidence base is dated (1992 to 1998) and limited in size-contemporary, adequately powered RCTs with standardized outcome measures are needed. Clinicians may prefer pseudoephedrine for short-term prophylaxis in adults without contraindications, alongside non-pharmacologic measures.