Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss

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.

Study Overview

• Status: Recruiting
• Conditions: Sudden Hearing Loss
• Intervention / Treatment: Device: Acupuncture; Drug: steroid therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming-Cheng Huang, M.D., Ph.D.; Phone Number: +886-4-22052121 Ext. 14561; Email: mchuang1128@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • China Medical University Hospital
    • Contact: Ming-Cheng Huang, M.D., Ph.D.; Phone Number: +886-4-22052121 Ext. 14561; Email: mchuang1128@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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: 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.	Device: 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 (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.
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pure-tone audiograms	Changes from baseline to week 1, week 2, and week 4 of the intervention	baseline, week 1, week 2, and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Handicap Inventory	Changes from baseline to week 1, week 2, and week 4 of intervention	baseline, week 1, week 2, and week 4
Dizziness Handicap Inventory	Changes from baseline to week 1, week 2, and week 4 of intervention	baseline, week 1, week 2, and week 4
Blood examination	neutrophil-to-lymphocyte ratio (NLR)	baseline
Laboratory examination	inflammatory cytokine test (IL-1β, IL-6, TNF-α)	baseline
Adverse events	Adverse events related to steroid or acupuncture therapy were recorded throughout the trial.	baseline, week 1, week 2, and week 4

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: acupuncture; sudden hearing loss
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sudden; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: CMUH113-REC2-096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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