Efficacy and safety of gastrodin acupoint injection as an adjunctive therapy for sensorineural hearing loss with vertigo: A randomized controlled trial.

BACKGROUND

Sensorineural hearing loss (SNHL) with vertigo causes substantial auditory and quality-of-life burden. We evaluated gastrodin acupoint injection (GAI) as an adjunct to conventional treatment.

METHODS

In this single-center open-label trial, 100 adults with SNHL and vertigo were randomized 1:1 to GAI plus conventional therapy or conventional therapy alone for 4 weeks. Co-primary outcomes were week-4 changes in pure-tone average (PTA) and Dizziness Handicap Inventory (DHI). The intention-to-treat analysis used multiple imputation for seven missing week-4 assessments; complete-case analysis was a sensitivity analysis.

RESULTS

The adjusted GAI-minus-control difference was -9.58 dB for PTA (95% CI, -12.55 to -6.61) and - 13.57 points for DHI (95% CI, -17.52 to -9.63); both remained significant after Holm adjustment. Complete-case estimates were similar (-9.72 dB and - 13.83 points). Exploratory Siegel recovery categories differed between groups (P < 0.001), with any Siegel-defined improvement in 47/47 GAI participants and 32/46 controls with observed audiometry. Exploratory secondary and biomarker comparisons remained significant after false-discovery-rate adjustment. Adverse events occurred in 10/50 GAI and 9/50 control participants; no serious adverse events occurred.

CONCLUSIONS

Allocation to the GAI treatment package was associated with greater week-4 improvement in hearing and self-reported dizziness handicap. Without a sham injection and with multiple background therapies, the gastrodin-specific effect cannot be isolated. Multicenter sham-controlled studies with objective follow-up vestibular testing are needed.