Qu 2015.
Study characteristics | ||
Methods | Non‐blinded, parallel‐group randomised controlled trial with 10 days duration of treatment and a 10 days duration of follow‐up | |
Participants |
Setting: tertiary referral centre, China, July 2012 to July 2014 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: diagnosis of ISSNHL, age 18 to 65 years; onset was less than 2 weeks and no previously treatment Exclusion criteria: family history of deafness, previous history of otitis media, external or middle ear disease, ototoxic drug use or long‐term exposure to noise |
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Interventions |
General comparison: intratympanic corticosteroids versus post auricular injection of corticosteroids and systemic corticosteroids Intervention group (n = 57*): "intratympanic therapy": intratympanic injections of methylprednisolone 40 mg, 5 injections in total, 1 x every 2 days for 10 days Comparator group I (n = 62*): "post auricular injection": post auricular injection of methylprednisolone 40 mg, 5 injections in total, 1 x every 2 days for 10 days Comparator group II (n = 69*): "systemic therapy": methylprednisolone 80 mg intravenous once a day, after 4 days reduced to 40 mg once a day for 3 days Use of additional interventions (common to all treatment arms): vasodilators, neurotropic drugs, anticoagulant drugs for 10 days *intention‐to‐treat analysis |
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Outcomes |
Primary outcome measure:
Secondary outcomes:
Primary endpoint for hearing threshold evaluation: 10 days Used PTA: information not provided |
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Funding sources | No information available | |
Declarations of interest | No information provided | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were randomised after random number table. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment is not described. |
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. Treatment delay from onset to initial therapy in patients not reported. Hearing loss before treatment not adequately reported Early endpoint of 10 days after start of treatment only. Unexplained difference in number of patients between treatment arms. |