| Methods |
Randomised, double‐blind (until surgery) |
| Participants |
Patients with Ménière's disease |
| Interventions |
Ventilation tubes versus endolymphatic sac shunting |
| Outcomes |
Vertigo
Hearing
Tinnitus/aural fullness |
| Notes |
1‐year follow‐up |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The method of randomisation was not described |
| Allocation concealment (selection bias) |
Low risk |
The randomisation results were kept in sealed envelopes; these were opened just before start of the surgery |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Neither the patients, nor the surgeons, nor the investigators were blind to the intervention used |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
There were no losses to follow‐up |
| Selective reporting (reporting bias) |
High risk |
The investigators and patients were not blinded to the intervention used |
| Follow‐up |
High risk |
Follow‐up was 1 year |
| Certainty of diagnosis |
Low risk |
The AAO‐HNS criteria were used |
