Tucci 2002.
Methods | Double‐blinded, randomised controlled trial | |
Participants | 105 patients from 32 study centres were recruited but only 94 completed the trial; 10 were then deleted from the final analysis resulting in 84 patients being evaluated Inclusion criteria: (i) Loss of at least 30 dB in 3 contiguous frequencies over a period of < 3 days in patients who have been monitored previously for hearing loss (ii) Subjective marked loss of hearing in patients with subjectively normal baseline hearing and no previous record of audiometry (in these patients hearing in the contralateral ear was taken as “baseline”) (iii) Patients seen within 10 days of onset of hearing loss (iv) No underlying disease that could be associated with sudden sensorineural hearing loss as an aetiologic factor |
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Interventions | 50 patients received prednisolone (80 mg/day for 4 days then tapered over 8 days) with placebo and 44 patients received prednisone with valacyclovir (1 g, 3 times a day for 10 days) | |
Outcomes | (i) Audiometric assessment at presentation, week 2 and week 6 (ii) Hearing Screening Inventory questionnaire twice weekly for 6 weeks (iii) Acute Short Form‐12 questionnaire at presentation and week 2 | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not described |
Allocation concealment (selection bias) | Low risk | Principal author stated that allocation was concealed by the pharmacist at their clinical research institute |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Excluded patients accounted for |
Selective reporting (reporting bias) | Unclear risk | The study did not have a pre‐published protocol for comparison |
Other bias | Low risk | No other sources of bias identified |