Outcome Indicators in Randomized Controlled Trials on Traditional Chinese Medicine Treatment of Vertigo
10.13422/j.cnki.syfjx.20231216
- VernacularTitle:中药治疗眩晕随机对照试验的结局指标分析
- Author:
Yanhua JIANG
1
;
Zhiwei JING
1
;
Zhenzhen QIAN
1
;
Sha ZHOU
2
;
Jian ZHU
1
;
Guang WU
3
;
Hongli WU
1
Author Information
1. Institute of Basic Research In Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700，China
2. The Second Affiliated Clinical School， Guangzhou University of Chinese Medicine， Guangzhou 510405，China
3. The First Clinical Medical College of Henan University of Chinese Medicine， Zhengzhou 450046，China
- Publication Type:Journal Article
- Keywords:
Traditional Chinese medicine;
vertigo;
randomized controlled trial;
outcome indicator
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(22):136-145
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThis study analyzed the outcome indicators in randomized controlled trials （RCTs） on traditional Chinese medicine （TCM） treatment of vertigo， aiming to provide a reference for clinical trial protocol design and the establishment of core indicator sets for vertigo treatment. MethodCNKI， Wanfang， VIP， SinoMed， PubMed， Embase， and Web of Science were searched for the RCTs on TCM treatment of vertigo， and data extraction was conducted. ResultA total of 375 RCTs involving 33 593 patients were included， from which 482 outcome indicators were extracted， with a frequency of 2 715 and an average of seven outcome indicators used for each RCT. In addition， there were some differences in outcome indicators reported by different study groups. According to the functional properties， the reported outcome indicators were classified into nine domains： clinical symptoms and signs， TCM symptom efficacy， physical and chemical examinations， quality of life， mental health， safety events， patients’ satisfaction degree， long-term prognosis， and economic evaluation. The outcome indicators with higher frequency were clinical total effective rate， total TCM symptom score， occurrence of adverse reactions， dizziness handicap inventory （DHI） score， average flow velocity of the basilar artery， incidence of adverse reactions， average flow velocity of the left vertebral artery， average flow velocity of the right vertebral artery， plasma viscosity， and vertigo score. ConclusionThe outcome indicators reported by RCTs of TCM treatment of vertigo mainly have two problems： lack of unified standards and norms and insufficient attention to outcome indicators that can reflect the characteristics of TCM. The construction of the core indicator set for TCM treatment of vertigo should fully highlight the characteristic advantages of TCM and unify the standards and norms for the outcome indicators on this basis， so as to improve the quality of clinical research and the value of secondary research.
