Efficacy and safety of ambroxol hydrochloride in the treatment of secretory otitis media: a systematic review and meta-analysis

BACKGROUND: Secretory otitis media is a very common nonsuppurative inflammatory disease in otorhinolaryngology. Ambroxol hydrochloride helps to improve ciliary movement in the ear canal and promote the dissolution and discharge of secretions. However, its effect still lacks systematic evaluation. We conducted a meta-analysis of clinical studies to systematically evaluate the application effect of ambroxol hydrochloride. METHODS: A computer-based search of the Chinese Biomedical Database (CBM), China National Knowledge Infrastructure (CNKI), PubMed, and Web of Science databases was conducted using the keywords “Ambroxol hydrochloride” & “secretory otitis media”. Randomized controlled trials published after 2015 were selected and then screened and analyzed using RevMan 5.4 software. RESULTS: Ten studies involving a total of 998 patients were included. Meta-analysis showed that adding ambroxol hydrochloride to the original glucocorticoid treatment improved therapeutic efficacy [odds ratio (OR) =4.95, 95% confidence interval (CI): 3.27, 7.50, P<0.00001], reduced tympanic pressure after treatment [mean difference (MD) =−19.04, 95% CI: −22.72, −15.36, P<0.00001], and increased the pure tone threshold (MD =6.37, 95% CI: 5.36, 7.37, P<0.00001), without increasing adverse reactions (OR =0.51, 95% CI: 0.14, 1.85, P=0.30). DISCUSSION: On the basis of the original treatment of secretory otitis media, adding ambroxol hydrochloride treatment improved the therapeutic effect, reduced tympanic pressure after treatment, and improved the pure tone threshold (hearing), without increasing adverse reactions.