Efficacy and Safety of Gastrodin Acupoint Injection as an Adjunctive Therapy for Sensorineural Hearing Loss With Vertigo: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Pure Tone Average (PTA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
GAI Group
Participants received conventional therapy plus Gastrodin Acupoint Injection (GAI).
干预措施: Gastrodin Injection (Drug)
Control Group
Participants received conventional therapy only.
干预措施: Conventional Therapy (Drug)
结局指标
主要结局
Change in Pure Tone Average (PTA)
时间窗: Baseline and Week 4
Calculated as the average of air-conduction hearing thresholds at 0.5, 1, 2, and 4 kHz measured by audiometry.
Change in Dizziness Handicap Inventory (DHI) Score
时间窗: Baseline and Week 4
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.
次要结局
- Change in Word Recognition Score (WRS)(Baseline and Week 4)
- Change in Tinnitus Evaluation Questionnaire (TEQ) Score(Baseline and Week 4)
- Change in Hamilton Anxiety Scale (HAMA) Score(Baseline and Week 4)
- Change in Hamilton Depression Scale (HAMD) Score(Baseline and Week 4)
- Change in Mean Flow Velocity (Vm) of Middle Cerebral Artery(Baseline and Week 4)
- Change in Pulsatility Index (PI) of Middle Cerebral Artery(Baseline and Week 4)
- Change in Serum Endothelin-1 (ET-1) Level(Baseline and Week 4)
- Change in Serum Nitric Oxide (NO) Level(Baseline and Week 4)
- Incidence of Adverse Events(From enrollment through study completion, an average of 4 weeks)
研究者
Wu Yuan
Doctor
The First Hospital of Hebei Medical University