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

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:
  • Number randomised: 84

  • Number completed: 84


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): 43.8 ± 13.4 y/not provided/72.0 ± 18.6 dB HL/6.2 ± 2.4 d

  • Group II (pharyngotympanic tube): 42.5 ± 11.6 y/not provided/71.0 ± 18.7 dB HL/5.8 ± 3.5 d

  • Group III (systemic intravenous): 45.2 ± 11.5 y/not provided/70.0 ± 17.6 dB HL/5.2 ± 3.1 d

  • Group IV (systemic oral): 42.1 ± 10.2 y/not provided/69.0 ± 16.5 dB HL/5.2 ± 2.8 d


Inclusion criteria: unilateral ISSNHL
Exclusion criteria: middle ear or retrocochlear disease, previous history of hearing loss, previously treatment, age over 65 years
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
Outcomes Primary outcome measure:
  • Proportion of patients whose hearing is improved (criterion of improvement > 15 dB decease in PTA)


Secondary outcomes:
  • Change in hearing threshold with pure tone audiometry


Primary endpoint for hearing threshold evaluation: 17 or 27 days
Used PTA: 4PTA (0.5, 1, 2, 4 kHz)
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.