Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pure-tone audiograms
研究概览
简要总结
Sudden hearing loss is an emergency in otolaryngology that requires diagnosis and treatment as soon as possible. The golden treatment period is two weeks since the onset of the disease. However, modern medicine is still unable to fully understand the causes of the disease and in lack of corresponding effective treatments. Current therapies also have their own limitations and side effects. To find an effective and safe treatment, integrating with modern medicine and providing inpatient and outpatient medical care, is an important issue in clinical care. Traditional Chinese medicine has been clinically utilized for a long time with accumulated empirical experience and evidence for its efficacy. It can be used as an alternative therapeutic option for sudden hearing loss.
Being with a long period of clinical experience and evidence-based curative effect, acupuncture could be applied as an adjunctive treatment for the sudden hearing loss. Currently, this patient-centered, pragmatic clinical trial compares the effectiveness of using west medicine、combination of west medicine and traditional Chinese medicine. The aim of this study is to explore acceptable and beneficial strategy to reduce the clinical symptoms, to improve quality of life, and decrease medical expenses.
详细描述
Patients newly diagnosed with sudden deafness were randomly assigned in a 1:1 ratio to two groups: a Western medicine group and an integrated Chinese and Western medicine treatment group. Each group included 32 patients, for a total of 64 patients. Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care.
Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.
Traditional Chinese Medicine Treatment: Acupuncture was performed once daily for 30 minutes at acupoints around the ear and upper limb on the same side as the affected ear. Six treatment sessions were performed in the first and second weeks, and two sessions were performed in the third and fourth weeks.
Primary Outcome: Pure-tone audiograms were performed at baseline, week 1, week 2, and week 4.
Secondary Outcome: Tinnitus Handicap Inventory and Dizziness Handicap Inventory were performed at baseline, week 1, week 2, and week 4. Blood biochemistry tests were performed at baseline. Adverse events were recorded throughout the trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, both male and female.
- •Meeting the diagnostic criteria for sudden sensorineural hearing loss (SSNHL), defined as hearing loss of >30 dB affecting at least three consecutive frequencies within 3 days.
- •Newly onset of hearing loss within 2 week.
- •Fully understanding the purpose and procedures of the study and providing signed informed consent.
排除标准
- •Central nervous system lesions such as vestibular schwannoma or traumatic brain injury.
- •Middle ear or retrocochlear pathology.
- •History of otologic surgery.
- •Hemorrhagic disorders or coagulation abnormalities.
- •Inability to cooperate with examinations due to dementia or psychiatric illness.
- •Previous treatment for SSNHL on the same affected side within the past 6 months.
研究组 & 干预措施
Steroid therapy combined with acupuncture
Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.
Traditional Chinese Medicine Treatment: Acupuncture was performed once daily for 30 minutes at acupoints around the ear and upper limb on the same side as the affected ear. Six treatment sessions were performed in the first and second weeks, and two sessions were performed in the third and fourth weeks.
干预措施: Acupuncture (Device)
Steroid therapy
Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.
干预措施: steroid therapy (Drug)
结局指标
主要结局
Pure-tone audiograms
时间窗: baseline, week 1, week 2, and week 4
Changes from baseline to week 1, week 2, and week 4 of the intervention
次要结局
- Tinnitus Handicap Inventory(baseline, week 1, week 2, and week 4)
- Dizziness Handicap Inventory(baseline, week 1, week 2, and week 4)
- Blood examination(baseline)
- Laboratory examination(baseline)
- Adverse events(baseline, week 1, week 2, and week 4)