Swachia 2016.

Study characteristics
Methods	Non‐blinded, parallel‐group randomised controlled trial with 2 weeks duration of treatment and 2‐month duration of follow‐up
Participants	Setting: tertiary referral centre, India, dates not provided Sample size: Number randomised: 42 Number completed: 42 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): not reported/not reported/66.1 ± 24.2 dB HL/not reported Group II (systemic): not reported/not reported/61.0 ± 22.0 dB HL/not reported Inclusion criteria: > 18 years, SSNHL meeting NIDCD criteria, occurred within a course of 14 daysExclusion criteria: prior history of ear disease, history of noise‐induced trauma, congenital hearing loss, pregnancy, contraindication for steroids, history of head and neck cancer, undergone radiotherapy
Interventions	General comparison: intratympanic versus systemic therapy Intervention group (n = 20*): "intratympanic therapy": intratympanic injection of methylprednisolone, 40 mg/mL, 4 injections total, 2 times per week Comparator group (n= 22*): "systemic therapy": oral prednisone 1 mg/kg for 10 days, then 0.5 mg/kg for 2 days, 0.25 mg/kg for 2 days Use of additional interventions (common to both treatment arms): none *intention‐to‐treat analysis
Outcomes	Primary outcome measure: Change in hearing threshold with pure tone audiometry Secondary outcomes: Proportion of patients whose hearing is improved (criterion of improvement > 10 dB HL decrease in PTA, Furuhashi's criteria) Adverse events Primary endpoint for hearing threshold evaluation: 60 days Used PTA: 4PTA (0.5, 1, 2, 4 kHz)
Funding sources	None declared
Declarations of interest	Quote: "The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication" (organisation(s) not further specified).
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients … were randomly divided into two groups". Method of random sequence generation is not described.
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 in patients not reported. Unexplained difference in numbers of patients between groups.