Short-term Steroid for Acute Tinnitus Therapy
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to learn about the efficacy of oral steroids in the acute tinnitus population. The main question it aims to answer is whether oral prednisone intervenes with acute tinnitus as early as possible. Participants will receive appropriate dosages of prednisone and/or oral Ginkgo Biloba tablets.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Researchers will compare the steroid group and placebo control group to see whether short-term systemic steroid therapy is effective for acute tinnitus.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: prednisone plus placebo group The steroid group were administered oral prednisone and the maximum recommended dose was based on bodyweight as follows: weight< 40 kg: 40 mg/d; 40kg <= weight < 50kg: 50 mg/d; 50kg < weight: 60 mg/d. Oral prednisone was given at an initial maximum dose for 5 days, and, subsequently, with 10 mg/d tapered every 2 days for the following days. Total duration of treatment was from 7 to 10 days, and the recall period for outpatient visits was 1 week. Patients took oral standardized Ginkgo biloba extracts three times a day |
Drug: Prednisone tablet
The dose selection of oral prednisone is the maximum daily dose for 5 days, followed by a taper every 2 days
Other Names:
Drug: Ginkgo Biloba Extract
Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus
Other Names:
|
| Placebo Comparator: placebo group Patients took oral standardized Ginkgo biloba extracts three times a day. |
Drug: Ginkgo Biloba Extract
Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus
Other Names:
|
Outcome Measures
Primary Outcome Measures
- tinnitus handicap inventory (THI) [one week from baseline]
The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.
- tinnitus handicap inventory (THI) [one month from baseline]
The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.
Secondary Outcome Measures
- pure tone audiometry (PTA) [one week from baseline]
PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
- visual analog scale (VAS) [one week from baseline]
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
- visual analog scale (VAS) [one month from baseline]
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
- the Hospital Anxiety and Depression Scale (HADs) [one week from baseline]
The HADs consist of 14 items which are equally divided into two dimensions: a depression sub-scale (HADs-D) and an anxiety sub-scale (HADs-A). The grades are valued by scoring: negative (0-7), positive (8-21).
- the Hospital Anxiety and Depression Scale (HADs) [one month from baseline]
The HADs consist of 14 items which are equally divided into two dimensions: a depression sub-scale (HADs-D) and an anxiety sub-scale (HADs-A). The grades are valued by scoring: negative (0-7), positive (8-21).
- the Athens Insomnia Scale-8 (AIS-8) [one week from baseline]
The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-65 years old;
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primary complaint of non-pulsatile tinnitus ≤ 3 months of duration;
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a decline in auditory function by audiological assessments on the day of the test, of which the outcome must either satisfy one of the following conditions:
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a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results;
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more than a PTA threshold > 25 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss;
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a state of good general condition;
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with good adherence to participation and signed informed consent.
Exclusion Criteria:
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history of other obvious causes of tinnitus (such as otitis media, tympanic membrane perforation, external auditory canal inflammation);
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physical trauma to the ear immediately preceding tinnitus;
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both the PTA and DPOAE with normal outcomes;
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history of known corticosteroids contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnant patients, and women on estrogen-containing oral contraceptive steroids).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eye and ENT Hospital of Fudan University | Shanghai | China |
Sponsors and Collaborators
- Eye & ENT Hospital of Fudan University
Investigators
- Principal Investigator: Shan Sun, Eye and ENT Hospital of Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- tinnitus steroid therapy