Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Acupuncture
  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 on peri-auricular and ipsilateral upper limb points, including Ermen (TE
• Препарат steroid therapy
  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.

Первичные конечные точки

• Pure-tone audiograms [Срок оценки: baseline, week 1, week 2, and week 4]

Вторичные конечные точки (5)

• Tinnitus Handicap Inventory [Срок оценки: baseline, week 1, week 2, and week 4]
• Dizziness Handicap Inventory [Срок оценки: baseline, week 1, week 2, and week 4]
• Blood examination [Срок оценки: baseline]
• Laboratory examination [Срок оценки: baseline]
• Adverse events [Срок оценки: baseline, week 1, week 2, and week 4]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• China Medical University Hospital — Taichung

Идентификаторы

NCT: NCT07235488 · CMUH113-REC2-096

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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