Chinese Journal of Tissue Engineering Research ›› 2026, Vol. 30 ›› Issue (29): 7696-7705.doi: 10.12307/2026.264

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Outcome measures in randomized controlled trials of vestibular peripheral vertigo: a systematic evaluation of traditional Chinese medicine treatment

Hou Mingkai1, 2, Geng Siyu3, Qin Jinghan1, 2, Shen Liya4, Huang Haoxuan4, Zhao Qianao5, Zhang Daopei1, 2, 6, Zhang Huailiang1, 2, 6   

  1. 1Department of Encephalopathy, 4Department of Respiratory Medicine, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, Henan Province, China; 2Henan Collaborative Innovation Center for Prevention and Treatment of Major Diseases with Integrated Chinese and Western Medicine, Zhengzhou 450000, Henan Province, China; 3the Second Clinical Medical College of Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; 5Zhongjing Academy, Henan University of Chinese Medicine, Zhengzhou 450000, Henan Province, China; 6Henan Provincial Diagnosis and Treatment Center for Vertigo Diseases, Zhengzhou 450000, Henan Province, China
  • Received:2025-08-26 Revised:2025-12-22 Online:2026-10-18 Published:2026-03-07
  • Contact: Zhang Huailiang, Professor, Chief physician, Doctoral supervisor, Department of Encephalopathy, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, Henan Province, China; Henan Collaborative Innovation Center for Prevention and Treatment of Major Diseases with Integrated Chinese and Western Medicine, Zhengzhou 450000, Henan Province, China; Henan Provincial Diagnosis and Treatment Center for Vertigo Diseases, Zhengzhou 450000, Henan Province, China
  • About author:Hou Mingkai, MS candidate, Physician, Department of Encephalopathy, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, Henan Province, China; Henan Collaborative Innovation Center for Prevention and Treatment of Major Diseases with Integrated Chinese and Western Medicine, Zhengzhou 450000, Henan Province, China
  • Supported by:
    Guideline Group Standard Project of China Association of Chinese Medicine, No. 20220711-BZ-CACM (to ZHL); Major Special Project of Traditional Chinese Medicine Scientific Research in Henan Province, No. 2024ZYZD02 (to ZHL); Zhang Huailiang National Famous Veteran Traditional Chinese Medicine Expert Inheritance Studio Construction Project, No. National Administration of Traditional Chinese Medicine [2018]134 (to ZHL)

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Abstract: BACKGROUND: Vestibular peripheral vertigo is characterized by a wide range of diseases, profound impacts, and considerable challenges in prevention and treatment. It remains an urgent public health issue worldwide. Currently, randomized controlled trials on traditional Chinese medicine treatment for vestibular peripheral vertigo are complex and diverse, and lacking standardization and systematic sorting, which undermines the quality of evidence and the value of clinical translation.
OBJECTIVE: To review randomized controlled trials of traditional Chinese medicine for vestibular peripheral vertigo through systematic analysis, focusing on clinical research characteristics and outcome measures, thereby optimizing clinical guideline development and refining future trial design strategies.
METHODS: PubMed, Web of Science, The Cochrane Library, EMbase, CNKI, VIP, WanFang and SinoMed were searched by computer for relevant literature published up to April 18, 2025. Randomized controlled trials on traditional Chinese medicine for vestibular peripheral vertigo were collected. Two researchers independently performed literature screening, data extraction, and quality assessment of the included studies. Clinical outcome measures and relevant trial design elements were summarized through qualitative analysis.
RESULTS AND CONCLUSION: Finally, 166 randomized controlled trials were included, involving 14 718 patients and 119 outcome measures. The outcome indicators were divided into seven functional domains: symptom/sign indicators, traditional Chinese medicine syndrome, laboratory and imaging, safety, long-term prognosis, quality of life, and other indicators. At present, the randomized controlled trials on traditional Chinese medicine for vestibular peripheral vertigo lack standardized research designs, with insufficient uniformity in traditional Chinese medicine syndrome differentiation and measurement tools, as well as numerous methodological flaws. Prominent issues include heterogeneity in clinical outcome measures, imbalance between primary and surrogate endpoints, inappropriate selection of indicators, absence of economic evaluation metrics, and incomplete assessment systems for safety events and long-term prognosis. It is recommended that in the future, researchers should enhance methodological quality, rationally design outcome measures, and conform to the characteristics of the efficacy evaluation of traditional Chinese medicine clinical trials. This will facilitate the standardization of clinical guidelines and core outcome sets for peripheral vestibular vertigo, providing more scientific and effective evidence-based medical evidences for its precise prevention and treatment.


Key words: vestibular peripheral vertigo, traditional Chinese medicine, randomized controlled trials, outcome measures, quality of life, evidence-based medicine, clinical trial design, methodological quality

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