The effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENiere's disease (PREDMEN trial): a study protocol for a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial.

ABSTRACT:

Introduction

Intratympanic corticosteroids are commonly used in the treatment of Menière's disease (MD). However, few and small randomised controlled trials (RCT) on the effectiveness of intratympanic corticosteroids have been performed. A recent Cochrane review suggested that a well-conducted placebo-controlled RCT with a large study population is required to evaluate the effectiveness of the use of intratympanic corticosteroids in MD. The following protocol describes a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial to compare the effectiveness of methylprednisolone (62.5 mg/mL) to a placebo (sodium chloride 0.9%).

Methods and analysis

We aim to recruit 148 patients with unilateral MD from six hospitals in the Netherlands. Patients will be randoml

SUBMITTER: Boreel MME 

PROVIDER: S-EPMC11367374 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature