Peng 2008.
Study characteristics | ||
Methods | Non‐blinded, parallel‐group randomised controlled trial with 10 or 20 days duration of treatment and a 17 or 27 days duration of follow‐up | |
Participants |
Setting: tertiary referral centre, China, 2005 to 2007 Sample size:
Primary/secondary therapy: primary therapy Participant (baseline) characteristics: age/sex (male, female)/baseline hearing loss at start of therapy/start of treatment:
Inclusion criteria: unilateral ISSNHL Exclusion criteria: middle ear or retrocochlear disease, previous history of hearing loss, previously treatment, age over 65 years |
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Interventions |
General comparison: intratympanic corticosteroids versus injection of corticosteroids through pharyngotympanic tube versus systemic corticosteroids by intravenous and oral administration Intervention group I (n = 21*): "intratympanic therapy": intratympanic injections of dexamethasone 5 mg, 10 injections in total, 1x every day for 10 days Intervention group II (n = 21*): "injection through pharyngotympanic tube": injections of dexamethasone 5 mg with pharyngotympanic tube catheter, 10 injections in total, 1x every day for 10 days Comparator group I (n = 21*): "systemic therapy i.v.": dexamethasone intravenous 10 mg per day for 4 days; after 4 days 5 mg per day for 6 days Comparator group II (n = 21*): "systemic therapy p.o.": dexamethasone oral 0.75 mg, 3 times per day; after 7 days, 0.75 mg, 2 times per day for 3 days Use of additional interventions (common to all treatment arms): intravenous low molecular dextran 500 mL, buflomedil 0.2 g, energy mixture. Intramuscular injection of vitamin B1 0.1 g, B12 0.5 mg, once a day for 10 days Patients underwent 1 or 2 treatment cycles depending on pure tone audiometry after the first treatment cycle. *intention‐to‐treat analysis |
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Outcomes |
Primary outcome measure:
Secondary outcomes:
Primary endpoint for hearing threshold evaluation: 17 or 27 days Used PTA: 4PTA (0.5, 1, 2, 4 kHz) |
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Funding sources | No information available | |
Declarations of interest | No information provided | |
Notes | Data from the oral systemic treatment arm were included in the review | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Randomisation according to date of visit of patients. |
Allocation concealment (selection bias) | High risk | No allocation concealment possible because of the method of random sequence generation used. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Open‐label trial, no blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement (not mentioned). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data reported. |
Selective reporting (reporting bias) | Low risk | No indication of selective reporting in the outcome parameters addressed by the review. |
Other bias | High risk | No sample size calculation performed. Wide range of treatment delay from onset among included patients. Different time of treatment (10 or 20 days) and follow‐up (17 or 27 days) between patients within groups. |