Efficacy and safety of gastrodin acupoint injection as an adjunctive therapy for sensorineural hearing loss with vertigo: A randomized controlled trial
4 affiliations
- 1Department of Otolaryngology Head and Neck Surgery, The First Hospital of Zhangjiakou, No. 6 Xinhua Street, Qiaoxi District, Zhangjiakou, Hebei, 075000, China
- 2Department of Neurosurgery, The First Hospital of Zhangjiakou, No. 6 Xinhua Street, Qiaoxi District, Zhangjiakou, Hebei, 075000, China; Corresponding author at: Department of Neurosurgery, The First Hospital of Zhangjiakou (West Campus), 2nd Floor, Building 4, West Campus of The First Hospital, Qiaoxi District, Zhangjiakou, Hebei, 075000, China.
- 3Department of Neurosurgery, The First Hospital of Zhangjiakou, No. 6 Xinhua Street, Qiaoxi District, Zhangjiakou, Hebei, 075000, China
- 4Department of Traditional Chinese Medicine, The First Hospital of Zhangjiakou, No. 6 Xinhua Street, Qiaoxi District, Zhangjiakou, Hebei, 075000, China
Abstract
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.
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BibTeX
@article{wang2026efficacy,
title = {{Efficacy and safety of gastrodin acupoint injection as an adjunctive therapy for sensorineural hearing loss with vertigo: A randomized controlled trial}},
author = {Zhijie Wang and Dongchen Geng and Wu Yuan and Huijuan Zhang and Xiaoqin Zhao and Tao Yang},
journal = {American Journal of Otolaryngology},
year = {2026},
month = oct,
doi = {10.1016/j.amjoto.2026.104955},
url = {https://doi.org/10.1016/j.amjoto.2026.104955},
note = {CC BY},
}
RIS
TY - JOUR
TI - Efficacy and safety of gastrodin acupoint injection as an adjunctive therapy for sensorineural hearing loss with vertigo: A randomized controlled trial
AU - Zhijie Wang
AU - Dongchen Geng
AU - Wu Yuan
AU - Huijuan Zhang
AU - Xiaoqin Zhao
AU - Tao Yang
PY - 2026
DA - 2026/10/30
JO - American Journal of Otolaryngology
DO - 10.1016/j.amjoto.2026.104955
UR - https://doi.org/10.1016/j.amjoto.2026.104955
AB - 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.
SN - 1532-818X
SN - 0196-0709
ER -