دورية أكاديمية

Placebo effect in randomized controlled trials for Meniere's disease: A meta-analysis.

التفاصيل البيبلوغرافية
العنوان: Placebo effect in randomized controlled trials for Meniere's disease: A meta-analysis.
المؤلفون: Taniguchi AN; Department 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., Sutton SR; Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, SC 29425, USA; University of Nevada, Reno School of Medicine, 1664 N Virginia St, Reno, NV 89557, USA., Mills JF; Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, SC 29425, USA., Nguyen SA; Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, SC 29425, USA. Electronic address: nguyensh@musc.edu., Rizk HG; Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, SC 29425, USA., Meyer TA; Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, SC 29425, USA., Nguyen JP; Sound Pharmaceuticals Inc, 4010 Stone Way N, Seattle, WA 98103, USA., Lambert PR; Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, SC 29425, USA.
المصدر: American journal of otolaryngology [Am J Otolaryngol] 2024 Mar-Apr; Vol. 45 (2), pp. 104178. Date of Electronic Publication: 2023 Dec 11.
نوع المنشور: Systematic Review; Meta-Analysis; Journal Article
اللغة: English
بيانات الدورية: Publisher: Saunders Country of Publication: United States NLM ID: 8000029 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-818X (Electronic) Linking ISSN: 01960709 NLM ISO Abbreviation: Am J Otolaryngol Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Cherry Hill, N. J., Saunders.
مواضيع طبية MeSH: Meniere Disease*/drug therapy , Tinnitus*/etiology , Tinnitus*/therapy, Humans ; Placebo Effect ; Randomized Controlled Trials as Topic ; Vertigo/etiology ; Vertigo/drug therapy
مستخلص: Purpose: Meniere's Disease is a condition known for its recurrent vertigo, fluctuating sensorineural hearing loss, aural fullness, and tinnitus. Previous studies have demonstrated significant influence of placebo treatments. Our objective was to quantify the magnitude of the placebo effect in randomized controlled trials for Meniere's Disease.
Materials and Methods: A systematic review was performed by searching PubMed, SCOPUS, CINAHL, and Cochrane databases from inception through September 27, 2022. Data extraction, quality rating, and risk of bias assessment were performed by two independent reviewers. A meta-analysis of mean differences with 95 % confidence interval, weighted summary proportions, and proportion differences were calculated using random and fixed effects models.
Results: A total of 15 studies (N = 892) were included in the review. Significant improvement was seen in the functional level scores of the pooled placebo groups, with a mean difference of -0.6 points, (95%CI: -1.2 to -0.1). There was no difference in pure tone audiometry, speech discrimination score, or vertigo frequency at 1 and 3 months for the placebo group. Patient-reported vertigo episodes were improved in 52.5 % (95%CI: 39.2 to 65.5) of the placebo group and was significantly less than the pooled experimental group (90.1 %, 95%CI: 39.2 to 65.5, p < 0.001).
Conclusions: The placebo effect in Meniere's Disease trials is associated with some symptomatic improvement in subjective outcomes, such as patient reported vertigo episodes. However, the clinical significance is questionable across other outcomes measures, especially when analyzing objective data. The extent and strength of the placebo effect continues to be a hurdle in the search for better treatment options.
Competing Interests: Declaration of competing interest The authors have no conflict of interest to disclose.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
فهرسة مساهمة: Keywords: Meniere's Disease; Placebo effect; Vertigo
تواريخ الأحداث: Date Created: 20231215 Date Completed: 20240315 Latest Revision: 20240315
رمز التحديث: 20240315
DOI: 10.1016/j.amjoto.2023.104178
PMID: 38101129
قاعدة البيانات: MEDLINE
الوصف
تدمد:1532-818X
DOI:10.1016/j.amjoto.2023.104178