Cisplatin causes tinnitus and hearing loss that patients live with for life. This phase IIIB randomised trial tested high-dose intratympanic dexamethasone, delivered over an extended period, to prevent cisplatin-induced tinnitus (mean cisplatin dose 445 mg).
The efficacy signal was striking: no treated patient developed tinnitus, whereas 90% of untreated patients developed bilateral tinnitus, with a mean 20-point worsening on the Tinnitus Handicap Inventory. But the delivery carried a real price — 8.7% developed infection during treatment and 34.8% had a permanent tympanic membrane perforation at six months after device removal.
This is a genuine efficacy result undermined by an unacceptable complication rate as delivered. It argues that the drug works but the extended intratympanic delivery method needs redesign before routine use. Frame it to patients and colleagues as promising proof of concept, not a technique to adopt as described.
- No tinnitus in treated ears versus 90% bilateral tinnitus untreated
- But 34.8% permanent tympanic perforation at 6 months, and 8.7% infection
- Efficacy is real; the extended-delivery method is the problem
- Not ready for routine use as delivered — a proof of concept, not a protocol
The statistics, in plain English
A jump from 90% tinnitus to none is a large, unambiguous efficacy effect even in a small trial. But a 34.8% permanent perforation rate is a competing harm of similar magnitude, so the net benefit depends entirely on fixing the delivery — a reminder that efficacy and safety must be read together, not in sequence.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for ent & head and neck surgery, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free