Intratympanic Dexamethasone Efficacy in Preventing Cisplatin-induced Tinnitus: A Randomized Controlled Phase IIIB Clinical Trial.
Inmaculada Moreno, Antonio Belinchon
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In 30 seconds
This randomized, controlled phase IIIB trial assessed intratympanic dexamethasone for preventing tinnitus in patients with cancer receiving cisplatin-based chemotherapy. Of 34 recruited patients, 11 were excluded; the analysis included 23 patients with one treated and one untreated ear, plus 10 patients whose ears received no dexamethasone. After treatment, no patient reported tinnitus in either ear in the dexamethasone group, whereas bilateral tinnitus occurred in 90% of patients in the untreated control group, with mean Tinnitus Handicap Inventory worsening of 20.2 points. The authors concluded that dexamethasone prevented tinnitus without affecting hearing threshold.
Key findings
- No patient in the dexamethasone group reported tinnitus in either ear after treatment.
- Bilateral tinnitus occurred in 90% of patients in the untreated control group, with mean Tinnitus Handicap Inventory worsening of 20.2 points.
- Dexamethasone treatment was associated with 8.69% infection complications and 34.8% permanent perforation at 6 months after device removal.
Why it matters
Cisplatin-associated tinnitus can affect patients receiving cancer treatment, and this trial reports a potential preventive approach alongside chemotherapy. The findings are clinically notable but must be considered with the reported infection and persistent tympanic membrane perforation complications, as well as the study’s limited patient numbers.
What to keep in mind
The trial recruited 34 patients, with 11 excluded; the analyzed groups were small. The abstract does not report comparative statistical testing or longer-term outcomes beyond the stated 6-month perforation assessment.