Zhou 2011.
| Study characteristics | ||
| Methods | Non‐blinded, parallel‐group randomised controlled trial with 8 days duration of treatment and a 2‐month duration of follow‐up | |
| Participants |
Setting: tertiary referral centre, China, January 2004 to December 2006 Sample size:
Primary/secondary therapy: secondary therapy after failure of primary therapy (after 7 days of initiation of primary treatment) Primary therapy: 125 mg methylprednisolone intravenous for the first day, followed by 32 mg per day oral for 5 days, 16 mg per day for 1 day. Naftidrofuryl 200 mg oral 3 times a day, diazepam 5 mg oral 3 times a day and low molecular weight heparin 0.4 mL subcutaneous 2 times day or low molecular weight dextran 500 mL intravenous 4 times a day Participant (baseline) characteristics: age/sex (male, female)/baseline hearing loss at start of therapy/start of initial treatment/start of treatment/baseline SDS:
Inclusion criteria: at least a 30 dB hearing loss occurring over 3 frequencies. The symptoms had to occur over a 72‐hour period. "Poor prognosis" cases defined as meeting at least one of the following criteria: 1) hearing loss > 70 dB HL for 3 subsequent 1‐octave steps in frequency; 2) age of patient > 60 years; 3) the pattern of the audiogram flat or high‐frequency hearing loss; 4) presence of severe vertigo, and 5) time exceeded 2 weeks from onset to initial treatment; non‐ responsive to conventional therapy within the first 7 days Exclusion criteria: 1) a change of ≥ 15 dB in pure tone average (PTA) at 4 frequencies (0.5, 1, 2, 4 kHz) or an increase ≥ 15% in speech discrimination score (SDS) after the first 7 days of conventional steroid therapy; 2) evidence of acute otitis media or chronic otitis media on examination; 3) evidence of retrocochlear disease evident on magnetic resonance imaging; 4) history of otologic surgery; 5) history of Ménière's disease, autoimmune hearing loss, radiation‐induced hearing loss or other potential aetiology for sensorineural hearing loss; 6) history of genetic sensorineural hearing loss or known inner ear anomaly; 7) history of fluctuation of hearing before or after intratympanic therapy |
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| Interventions |
General comparison: combined versus systemic corticosteroid therapy Intervention group (n = 37*): "combined therapy": intratympanic injections of methylprednisolone 40 mg/mL, 0,5 mL, 4 injections total, 1 x every 2 days + systemic corticosteroid as in comparator group Comparator group (n = 39*): "systemic therapy": 16 mg methylprednisolone oral per day for 1 day and 8 mg per day for another 2 days (continuation of the primary therapy) Use of additional interventions (common to both treatment arms): naftidrofuryl 200 mg oral 3 times a day, diazepam 5 mg oral 3 times a day and low molecular weight heparin 0.4 mL subcutaneous 2 times a day or low molecular weight dextran 500 mL intravenous 4 times a day *modified intention‐to‐treat analysis |
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| Outcomes |
Primary outcome measure:
Secondary outcomes:
Primary endpoint for hearing threshold evaluation: 60 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 | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "Each patient … was given a consecutive number. The odd number patients were classified into a Control group… The even number patients were classified into a TR (transtympanic steroid) group." "Those patients who were classified into the TR group had a chance to choose the treatment protocol." |
| Allocation concealment (selection bias) | High risk | Method of concealment is not described. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial, no blinding. Patients in the treatment group could refuse therapy after allocation. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement (not mentioned). |
| Incomplete outcome data (attrition bias) All outcomes | High risk | No missing outcome data reported but 2 patients refused advised treatment (2.6%). |
| Selective reporting (reporting bias) | High risk | Not all pre‐specified follow‐up time points were reported. |
| Other bias | High risk | No sample size calculation performed. Hearing threshold before treatment in control group not reported. Inclusion criterion "Poor prognosis group" exhibits a possible bias in the selection of study population. Early start of secondary therapy after 7 days only. Treatment delay from onset to secondary treatment in patients not reported but reported treatment delay to initial treatment and duration of initial treatment. |
ATP: adenosine triphosphate CI: confidence interval CMV: cytomegalovirus d: days dB HL: decibels hearing level f: female h: hours HL: hearing loss HSV: herpes simplex virus (I)SSNHL: (idiopathic) sudden sensorineural hearing loss IT: intratympanic m: male MRI: magnetic resonance imaging n.a.: not available NIDCD: National Institute on Deafness and Other Communication Disorders PTA: pure tone average SD: standard deviation SDmax: maximum speech discrimination score SDS: speech discrimination score SE: standard error SPL: sound pressure level SRT: speech reception threshold TM: tympanic membrane WRS: word recognition score