Key Takeaways & Executive Findings
- •• A systematic review of 166 RCTs involving 14,718 patients identified 119 distinct outcome measures in TCM treatment for vestibular peripheral vertigo. • Outcome measures were categorized into 7 domains, with significant heterogeneity and imbalance between endpoint and surrogate indicators. • Methodological quality of the included RCTs was suboptimal, with lack of standardization in TCM syndrome types and measurement tools. • The study recommends improving methodological rigor and rational design of outcome measures to enhance the evidence base for TCM in vestibular peripheral vertigo.
Abstract
Background: Vestibular peripheral vertigo is characterized by a wide range of diseases, profound impact, and difficulty in prevention and treatment, posing a significant public health issue globally. Currently, randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for vestibular peripheral vertigo are complex and diverse, lacking standardized and systematic categorization, which constrains the quality of evidence-based evidence and clinical translation value. Objective: To systematically review RCTs of TCM for vestibular peripheral vertigo, analyze clinical research characteristics and outcome measures, to optimize the development of clinical guideline indicator sets and provide reference for future clinical trial design. Methods: PubMed, Web of Science, The Cochrane Library, EMbase, CNKI, VIP, Wanfang, and China Biology Medicine disc were searched from inception to April 18, 2025, to collect RCTs of TCM for vestibular peripheral vertigo. Two researchers independently conducted literature screening, data extraction, and quality assessment. Qualitative analysis was used to summarize clinical outcome measures and related trial design elements. Results and Conclusion: A total of 166 RCTs involving 14,718 patients were included, with 119 types of outcome measures. Outcome measures were categorized into 7 domains based on functional attributes: symptoms/signs, TCM syndromes, physical and chemical examinations, safety, long-term prognosis, quality of life, and others. Currently, the design of RCTs of TCM for vestibular peripheral vertigo has not formed a unified standard, with lack of standardization in TCM syndrome types and measurement tools, and numerous methodological quality issues. Clinical outcome measures exhibit prominent heterogeneity, imbalance between endpoint and surrogate indicators, unreasonable selection, neglect of economic indicators, and incomplete safety event and long-term prognosis evaluation systems. It is recommended that future researchers improve methodological quality, rationally design outcome measures, and align with the characteristics of TCM clinical trial efficacy evaluation, to promote the standardization of clinical guidelines and core indicator sets for vestibular peripheral vertigo, and provide more scientific and effective evidence-based medicine evidence for precise prevention and treatment.
1. Introduction
Vestibular peripheral vertigo refers to vertigo caused by lesions of the vestibular sensory receptors and the extracranial segment of the vestibular nerve, clinically manifesting as sudden rotational vertigo, often accompanied by spontaneous nystagmus, tinnitus, and hearing loss. It encompasses conditions such as benign paroxysmal positional vertigo, vestibular neuronitis, and Meniere's disease. Currently, there is a lack of unified epidemiological data on the incidence of vestibular peripheral vertigo; a U.S. National Health Interview Survey showed a 14.3% prevalence of vertigo in adults, with a significant increase in 10-year prevalence, and approximately 66.7% of vertigo originates from peripheral vestibular lesions. Furthermore, based on Korean demographic data from 2008-2020, the annual incidence of peripheral vestibular diseases such as benign paroxysmal positional vertigo, vestibular neuronitis, and Meniere's disease has been increasing year by year, particularly among women and the elderly. In China, epidemiological surveys indicate a high incidence of vertigo in clinical practice, with most vertigo caused by peripheral vestibular disorders. A single-center etiological analysis based on the International Classification of Vestibular Disorders showed that 56.1% of vertigo patients were diagnosed with peripheral vestibular diseases, with benign paroxysmal positional vertigo being the most common cause. Thus, such diseases constitute a major public health burden, closely related to their complex pathogenic mechanisms.
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HOU Mingkai, GENG Siyu, QIN Jinghan, SHEN Liya, HUANG Haoxuan, ZHAO Qianao, ZHANG Daopei, ZHANG Huailiang (2026). Outcome measures in randomized controlled trials of vestibular peripheral vertigo: a systematic evaluation of traditional Chinese medicine treatment. Chinese Journal of Tissue Engineering Research. https://doi.org/10.12307/2026.21433
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Frequently Asked Questions
What is vestibular peripheral vertigo?
Vestibular peripheral vertigo is a type of vertigo caused by lesions of the vestibular sensory receptors or the extracranial portion of the vestibular nerve. It is characterized by sudden rotational vertigo, often accompanied by nystagmus, tinnitus, and hearing loss. Common conditions include benign paroxysmal positional vertigo, vestibular neuronitis, and Meniere's disease.
What were the main findings of this systematic review?
The review included 166 randomized controlled trials with 14,718 patients and identified 119 different outcome measures. The outcome measures were categorized into seven domains. The study found significant heterogeneity in outcome selection, imbalance between endpoint and surrogate indicators, and methodological quality issues in the trials.
Why are outcome measures important in clinical trials?
Outcome measures are crucial because they determine how the effectiveness of an intervention is assessed. Appropriate outcome measures ensure accurate evaluation and reporting of results, and they should be accurate, objective, sensitive, stable, and feasible. In TCM trials, selecting appropriate outcome measures is essential for demonstrating efficacy and facilitating comparison across studies.
What recommendations were made for future research?
The authors recommend that future researchers improve methodological quality, standardize TCM syndrome types and measurement tools, and design outcome measures that align with the characteristics of TCM efficacy evaluation. This will help promote the standardization of clinical guidelines and core outcome sets for vestibular peripheral vertigo.
What is the significance of this study for clinical practice?
This study provides a comprehensive overview of the current state of outcome measures in TCM trials for vestibular peripheral vertigo. By highlighting the heterogeneity and methodological issues, it underscores the need for standardized outcome measures to enhance the quality of evidence, ultimately supporting more effective and evidence-based clinical decision-making.
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