OBJECTIVE: To estimate the frequency and strength of nocebo effects in trials for Meni?re disease (MD).DATA SOURCES: A literature search was conducted in PUBMED. The search terms we used were " Meni?re or Meni?re's," "treatment," and "placebo." Limitations included article type to be Clinical Trial or Randomized Controlled Trial, text availability to be Full text, Species to be Humans and Language to be English.STUDY SELECTION: We included placebo-controlled pharmaceutical RCTs that referred specifically to MD and recruited at least 10 adults in each arm. We excluded those studies with JADAD score ?3.DATA EXTRACTION: Thirty-six articles were screened identifying 12 eligible studies. Studies were included after consensus of both authors.DATA SYNTHESIS: The meta-analysis was conducted using the RevMan programme as suggested by the Cochrane Collaboration Group. Data were analyzed using a random effects model.CONCLUSION: Nocebo is an important confounding factor of the reported AEs in RCTs for treatment of MD and subsequently in the clinical practice. The pooled estimate of the percentage of placebo-treated patients with at least one AE was 42.3% (95% CI 8.1% to 16.3%), in comparison to 53.8% (95% CI 48.0% to 59.5%) for active drug-treated patients. Reporting of RCTs in MD is suboptimal and we recommend authors to endorse the CONSORT checklist.
Humans Meniere Disease