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. 2022 Jul 22;2022(7):CD008080. doi: 10.1002/14651858.CD008080.pub2

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:
  • Number randomised: 188

  • Number completed: 188


Primary/secondary therapy: primary therapy
Participant (baseline) characteristics: age/sex (male, female)/baseline hearing loss at start of therapy/start of treatment:
  • Group I (intratympanic): 16; 30; 11*/32 m, 25 f/not provided/not provided

  • Group II (post auricular): 18; 30; 14*/30 m, 32 f/not provided/not provided

  • Group III (systemic): 21; 35; 13*/36 m, 33 f/not provided/not provided

  • *n for 18 to 40; 41 to 59; > 60 y


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
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
Outcomes Primary outcome measure:
  • Proportion of patients whose hearing is improved (criterion of improvement > 15 dB decease in PTA)


Secondary outcomes:
  • Adverse events


Primary endpoint for hearing threshold evaluation: 10 days
Used PTA: information not provided
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.