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Placebo effect in randomized controlled trials for Meniere's disease: A meta-analysis
April N Taniguchi1, Sarah R Sutton2, John F Mills3
1Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, SC 29425, USA; University of Central Florida, College of Medicine, 6850 Lake Nona Blvd, Orlando, FL 32827, USA.
American Journal of Otolaryngology
|December 15, 2023
Summary
The placebo effect in Meniere's Disease trials shows some subjective improvement in vertigo episodes but lacks clinical significance in objective measures. This highlights a persistent challenge in developing effective treatments.
Area of Science:
- Otolaryngology
- Clinical Trials
- Neuroscience
Background:
- Meniere's Disease is characterized by recurrent vertigo, hearing loss, tinnitus, and aural fullness.
- Previous research indicates a notable placebo effect in Meniere's Disease clinical trials.
- Quantifying the placebo effect is crucial for accurate treatment evaluation.
Approach:
- A systematic review and meta-analysis was conducted.
- Searched PubMed, SCOPUS, CINAHL, and Cochrane databases up to September 2022.
- Included 15 studies with 892 participants, assessing outcomes using random and fixed effects models.
Key Points:
- Placebo groups showed a significant improvement in functional level scores (mean difference -0.6 points).
- No significant differences were observed in audiometry or vertigo frequency at 1-3 months.
- Patient-reported vertigo improved in 52.5% of the placebo group, significantly less than the experimental group (90.1%).
Conclusions:
- The placebo effect in Meniere's Disease trials influences subjective outcomes like vertigo episodes.
- Clinical significance is questionable for objective measures, particularly audiometry.
- The placebo effect remains a significant hurdle in advancing Meniere's Disease treatment research.
