Acupuncture combined with intratympanic dexamethasone for sudden sensorineural hearing loss: a randomized controlled trial

Background: The incidence of sudden sensorineural hearing loss (SSNHL) has been on the rise in recent years. This condition can cause permanent, irreversible hearing loss if left untreated. Acupuncture treatment for SSNHL has the potential advantages of safety, low cost, and promising benefits. Aim: This study aimed to explore the safety and efficacy of verum acupuncture (VA) versus sham acupuncture (SA) as an adjunctive therapy of intratympanic dexamethasone (ITD) for patients with SSNHL. Design and methods: This randomized, parallel, sham-controlled, single-centre prospective clinical trial was conducted from 5 May 2024 to 31 May 2025. Participants aged 18–65 with SSNHL were recruited at Eye & ENT Hospital, Fudan University, Shanghai, China. Eligible participants were randomly allocated (1:1) to receive VA combined with ITD or SA combined with ITD 4×/week for 1–2 weeks and a 6-week follow-up. The primary outcome was the improvement of pure tone average (PTA) from baseline to week 2. Results and conclusion: Of the 84 participants enrolled, 77 (91.7%) were included in the modified intention-to-treat analysis (44 men [57.1%]; median [IQR] age, 45.0 [34.0–58.5] years). Between-group comparisons revealed significant differences in hearing improvement as measured by PTA at week 2 (9.026 [95% CI, 2.127 to 15.926] dB; P = 0.011) in the VA + ITD group. VA combined with ITD may improve hearing among patients with SSNHL, producing more notable effects compared to SA combined with ITD. Trial registration: Chinese Clinical Trial Registry Identifier: ChiCTR2400082916.