Efficacy of standard care versus acoustic therapy on acute tinnitus in idiopathic sudden sensorineural hearing loss: a randomized controlled trial
Bibliographic record
Abstract
BACKGROUND: Idiopathic sudden sensorineural hearing loss (ISSHL) frequently occurs with acute tinnitus, causing significant quality-of-life disturbances. Acoustic therapy (AT) is commonly used, but its efficacy remains uncertain. This study aimed to compare the short-term and long-term efficacy of standard care versus AT in reducing tinnitus-related disturbances in ISSHL patients. METHODS: This study was designed as a two-stage approach. In stage I, a multi-center, multi-arm randomized controlled trial was conducted from May 1, 2019, to April 12, 2024, across 19 hospitals in Sichuan, China, involving 213 ISSHL patients with tinnitus. In stage II, participants were given the option to either continue personalized AT treatment at home or explore alternative therapeutic options, with their decisions and subsequent outcomes objectively monitored and recorded over a period of 6 months. Participants were randomly assigned to four groups for a short-term (10 days) inpatient intervention: Group A (international standard care: systemic steroid), Group B (Chinese standard care: systemic steroid plus intravenous batroxobin), Group C (international standard care with daily AT), and Group D (Chinese standard care with daily AT). After discharge, participants underwent a 170-day follow-up with optional long-term domestic AT. The primary outcome was short-term tinnitus remission (TR). Secondary outcomes included short-term changes in Tinnitus Handicap Inventory (THI), Tinnitus Questionnaire (TQ), customized visual analog scale (VAS) for hearing loss (HL-VAS) and tinnitus (T-VAS), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), 36-Item Health Survey Short Forms (SF-36), and the Pittsburgh Sleep Quality Index (PSQI) scores, and long-term changes including TR and HL-VAS and T-VAS. RESULTS: Among 213 enrolled participants, short-term analyses showed no statistically significant differences in TR or other outcomes (THI, TQ, BAI, BDI, SF-36, PSQI) among groups. Long-term analyses revealed higher TR in severe ISSHL patients who received long-term domestic AT (45.5% vs. 20.0%, P = 0.034), with no significant differences in other outcomes. Severe adverse events and deaths were not reported. CONCLUSIONS: AT may not provide immediate relief but shows potential for sustained TR in severe ISSHL. Future studies should optimize its timing, duration, and integration into treatment strategies. TRIAL REGISTRATION: This trial was registered at the Chinese Clinical Trial Registry (ChiCTR1900021725).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.024 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".