Gastrodin Acupoint Injection for Sensorineural Hearing Loss With Vertigo

Efficacy and Safety of Gastrodin Acupoint Injection as an Adjunctive Therapy for Sensorineural Hearing Loss With Vertigo: A Randomized Controlled Trial

Sensorineural hearing loss (SNHL) accompanied by vertigo is a significant clinical challenge. Current conventional treatments often offer limited efficacy. This study evaluates the efficacy and safety of Gastrodin Acupoint Injection (GAI) as an adjunctive therapy based on the Traditional Chinese Medicine (TCM) theory of "treating both liver and heart." The trial compares the outcomes of patients receiving conventional therapy alone versus those receiving conventional therapy combined with GAI to determine improvements in auditory function, vestibular symptoms, and quality of life.

Study Overview

• Status: Completed
• Conditions: Vertigo; Sensorineural Hearing Loss
• Intervention / Treatment: Drug: Gastrodin Injection; Drug: Conventional Therapy

Detailed Description

SNHL with vertigo significantly impacts patients' quality of life, often leading to psychological distress. The pathophysiology involves vascular compromise and inner ear hypoxia. While conventional treatments (corticosteroids, vasodilators) are standard, their efficacy can be inconsistent. TCM suggests that disharmony in the Liver and Heart contributes to these symptoms. Gastrodin, extracted from *Gastrodia elata*, has neuroprotective and circulation-promoting properties. Acupoint injection combines pharmacology with meridian stimulation.

This prospective, randomized, controlled trial enrolled 100 eligible patients assigned to either a GAI group or a Control group. Both groups received a standard regimen (Dextran-40, Ginkgo Biloba Extract, Mecobalamin, and Yufeng Ningxin Dripping Pills). The GAI group additionally received gastrodin injections at specific acupoints: Local points (Tinggong, Tinghui, Yifeng) and Distal points (Baihui, Taichong, Neiguan, Shenmen) alternating every two days for 4 weeks. Efficacy is assessed via audiometry, dizziness scales, tinnitus questionnaires, psychological scales, and hemodynamic/biomarker analysis.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Zhangjiakou, Hebei, China, 075000
      • The First Hospital of Zhangjiakou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meeting diagnostic criteria for SNHL with vertigo.
• Disease course of 3 to 30 days.
• Pure Tone Average (PTA) at 0.5, 1, 2, and 4 kHz between 30 and 90 dB HL.
• Willingness to participate and sign informed consent.

Exclusion Criteria:

• Conductive or mixed hearing loss.
• Hearing loss due to trauma, tumor, or infection.
• Meniere's disease.
• Severe systemic diseases (cardiovascular, cerebrovascular, renal, or hepatic).
• Pregnancy or lactation.
• Known allergy to any of the study medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GAI Group; Participants received conventional therapy plus Gastrodin Acupoint Injection (GAI).	Drug: Gastrodin Injection; 0.5 mL (25 mg) gastrodin injected into selected acupoints alternating between Set A (Tinggong, Tinghui, Yifeng) and Set B (Baihui, Taichong, Neiguan, Shenmen) once every two days for 4 weeks. Conventional therapy included: IV Dextran-40 (7 days), IV Ginkgo Biloba (14 days), oral Mecobalamin, and oral Yufeng Ningxin Dripping Pills.
Active Comparator: Control Group; Participants received conventional therapy only.	Drug: Conventional Therapy; Intravenous Dextran-40 (500 mL, daily for 7 days); Intravenous Ginkgo Biloba Extract (20 mL, daily for 14 days); Oral Mecobalamin tablets (0.5 mg, t.i.d.); Oral Yufeng Ningxin Dripping Pills (12 pills, t.i.d.) for 4 weeks. No sham injections were administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pure Tone Average (PTA)	Calculated as the average of air-conduction hearing thresholds at 0.5, 1, 2, and 4 kHz measured by audiometry.	Baseline and Week 4
Change in Dizziness Handicap Inventory (DHI) Score	The DHI is a 25-item self-assessment questionnaire evaluating the functional, emotional, and physical impact of dizziness. The total score ranges from 0 to 100. Higher scores indicate greater perceived handicap and more severe dizziness symptoms.	Baseline and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Word Recognition Score (WRS)	WRS assesses speech discrimination ability by measuring the percentage of words correctly identified from a phonetically balanced list at a comfortable listening level (40 dB above speech reception threshold). Scores range from 0% to 100%. Higher scores indicate better hearing function and speech understanding.	Baseline and Week 4
Change in Tinnitus Evaluation Questionnaire (TEQ) Score	The TEQ is used to assess the severity and impact of tinnitus on daily life. The questionnaire consists of items related to tinnitus characteristics and patient distress. Higher total scores indicate more severe tinnitus symptoms and a greater negative impact on the patient.	Baseline and Week 4
Change in Hamilton Anxiety Scale (HAMA) Score	The HAMA is a clinician-rated scale to measure the severity of anxiety symptoms. It consists of 14 items, each scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.	Baseline and Week 4
Change in Hamilton Depression Scale (HAMD) Score	The HAMD is a clinician-rated scale to measure the severity of depressive symptoms. It contains 17 or 24 items (depending on version used), with higher total scores indicating more severe depression.	Baseline and Week 4
Change in Mean Flow Velocity (Vm) of Middle Cerebral Artery	Vm is measured using Transcranial Doppler (TCD) ultrasound in the middle cerebral artery. Measured in cm/s. In the context of ischemic pathology, an increase in Vm (within normal ranges) indicates improved cerebral blood perfusion.	Baseline and Week 4
Change in Pulsatility Index (PI) of Middle Cerebral Artery	PI is a hemodynamic parameter measured using Transcranial Doppler (TCD) calculated as (Systolic Velocity - Diastolic Velocity) / Mean Velocity. It reflects downstream vascular resistance. A lower PI score indicates reduced vascular resistance and improved microcirculation.	Baseline and Week 4
Change in Serum Endothelin-1 (ET-1) Level	Measurement of serum ET-1 levels via enzyme-linked immunosorbent assay (ELISA). ET-1 is a potent vasoconstrictor. Lower levels indicate reduced vasoconstriction and potentially improved microcirculation.	Baseline and Week 4
Change in Serum Nitric Oxide (NO) Level	Measurement of serum NO levels via enzyme-linked immunosorbent assay (ELISA). NO is a vasodilator. Higher levels indicate improved vasodilation and endothelial function.	Baseline and Week 4
Incidence of Adverse Events	Number of participants with adverse events including local pain, hematoma, or systemic reactions, assessed using CTCAE v5.0.	From enrollment through study completion, an average of 4 weeks

Collaborators and Investigators

• Sponsor: The First Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Labyrinth Diseases; Vestibular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sensorineural; Vertigo; gastrodin
• Other Study ID Numbers: 2022072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No