Health TrialsbyHealthPanel

Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss

ConditionSudden Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina Medical University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Device

    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 (TE21), Tinggong (SI19), Tinghui (GB2), Shuaigu (GB8), Yifeng (TE17), Waiguan (TE5), and Zhongzhu (TE3). The treatment was administered once daily for 30 minutes. During the first and second weeks, a total of six sessions were carried out, followed by two sessions per week in the third and fourth weeks.

  • steroid therapy

    Drug

    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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Steroid therapy combined with acupunctureExperimental treatment 1 intervention
Group B: Steroid therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pure-tone audiograms

Changes from baseline to week 1, week 2, and week 4 of the intervention

Time frame
baseline, week 1, week 2, and week 4

Secondary outcomes

1

Tinnitus Handicap Inventory

Changes from baseline to week 1, week 2, and week 4 of intervention

Time frame
baseline, week 1, week 2, and week 4
2

Dizziness Handicap Inventory

Changes from baseline to week 1, week 2, and week 4 of intervention

Time frame
baseline, week 1, week 2, and week 4
3

Blood examination

neutrophil-to-lymphocyte ratio (NLR)

Time frame
baseline
4

Laboratory examination

inflammatory cytokine test (IL-1β, IL-6, TNF-α)

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University Hospital

Lead sponsor

Source ClinicalTrials.gov
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