The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). The main questions it aims to answer are: Does acupuncture combined with corticosteroids improve hearing recovery (pure tone audiometry, PTA) at 8 weeks compared with sham acupuncture combined with corticosteroids? Does this treatment improve secondary outcomes, including tinnitus, dizziness, sleep quality, anxiety, and quality of life? Researchers will compare acupuncture (experimental group) with sham acupuncture (control group) to determine the added therapeutic effect of acupuncture. Participants will: 1. Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks. 2. Meanwhile, take oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper. 3. Undergo hearing tests (PTA, word recognition scores), vestibular function tests, and complete validated questionnaires (SF-36, HADS, ISI, DHI, THI, and TCM symptom scales) at baseline and weeks 1, 2, 4, 8, and 12. 4. Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
256
Main Acupoints (Fixed): Tinghui (GB2), Yifeng (SJ17), Tinggong (SI19), and Shuaigu (GB8) on the affected side; Baihui (GV20) at the vertex; Zhongzhu (SJ3) and Zulinqi (GB41) bilaterally. Adjunct Acupoints (Bilateral, selected based on TCM pattern differentiation): External Pathogen Invasion: Hegu (LI4) + Waiguan (SJ5) Liver Fire Harassing Upper: Yanglingquan (GB34) + Xingjian (LR2) Phlegm Fire Stagnation: Fenglong (ST40) + Neiting (ST44) Qi Stagnation and Blood Stasis: Xuehai (SP10) + Taichong (LR3) Kidney Essence Deficiency: Taixi (KI3) + Sanyinjiao (SP6) Spleen and Stomach Deficiency: Zusanli (ST36) + Qihai (CV6)
The same acupoints are used, but with blunt-tip placebo needles that do not penetrate the skin. The needles are fixed with adhesive patches, and the procedure is identical to the real acupuncture group to maintain blinding.
Eye and ENT Hospital of Fudan University
Shanghai, China
RECRUITINGHearing improvement
Hearing improvement measured by the change in Pure Tone Audiometry (PTA) average (500, 1000, 2000, and 4000 Hz) from baseline to week 8, compared between the acupuncture + corticosteroid group and the sham acupuncture + corticosteroid group.
Time frame: Week 8
Hearing outcomes at multiple time points
Changes in PTA at weeks 1, 2, 4, 8, and 12
Time frame: week 1, 2, 4, 8, and 12
Word Recognition Score (WRS)
Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Sudden hearing loss recovery grade
Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria
Time frame: weeks 1, 2, 4, 8, and 12
TCM symptom score
Change from baseline to week 8 using the pattern-specific TCM symptom scale
Time frame: week 8
Sensory Organization Test
Sensory Organization Test (SOT) scores at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Insomnia Severity Index (ISI)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Dizziness Handicap Inventory (DHI)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Tinnitus Handicap Inventory (THI)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Hospital Anxiety and Depression Scale (HADS)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Quality of life (SF-36)
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Aural fullness scale (AFS)
Visual analog scale (0-10) changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Salvage treatment rate
Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14
Time frame: day 14
Safety outcome
Proportion of adverse events in both groups at week 8
Time frame: week 8
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