Analysis of RCT outcome indicators of traditional Chinese medicine for essential hypertension in recent two years.
10.19540/j.cnki.cjcmm.20200730.502
- Author:
Rui-Xue HU
1
;
Xing-Jiang XIONG
2
;
Ren-Bo CHEN
1
;
Wei YANG
1
;
Hui ZHAO
3
;
Yong-Yan WANG
1
;
Xing LIAO
1
Author Information
1. Office of Basic Research in Evidence-based Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China.
2. Guang'anmen Hospital,China Academy of Chinese Medical Sciences Beijing 100053,China.
3. China Center for Evidence Based Traditional Chinese Medicine Beijing 100700,China.
- Publication Type:Journal Article
- Keywords:
essential hypertension;
outcome indicator;
randomized controlled trial;
traditional Chinese medicine
- MeSH:
Endpoint Determination;
Essential Hypertension;
Humans;
Medicine, Chinese Traditional;
Quality of Life;
Randomized Controlled Trials as Topic;
Treatment Outcome
- From:
China Journal of Chinese Materia Medica
2021;46(6):1547-1557
- CountryChina
- Language:Chinese
-
Abstract:
To find the status of outcome indicators reported in published randomized controlled trial(RCT) of traditional Chinese medicine(TCM) for essential hypertension in the past two years, we searched for relevant information from four Chinese databases, three English databases and two clinical trial registries in this study, from January 2018 to September 2019. The outcome indicators of RCT were extracted and categorized from trials and the risk of bias was assessed by ROB tools from the Cochrane Collaboration. A total of 125 RCTs and 15 RCT protocols were finally included after study screening. The results showed that the RCT outcomes mainly included efficacy and safety outcomes. Efficacy indicators mainly included blood pressure measurement, quality of life assessment, blood biochemical indicators, urine analysis, arterial ultrasound, vascular endothelial function indicators, hematocrit, hemorheology indicators and other indicators. The safety indicators mainly included general physical examination items, heart, liver and kidney function tests, blood, urine, and stool routine examinations as well as adverse drug reactions/events. The current RCTs cannot distinguish primary and secondary outcomes, and the RCT protocols didn't report efficacy criteria clearly. They both didn't report health economic indicators and the methodological qualities were relatively low. In view of the current status on outcome indicators reported in TCM RCTs, constructing a core outcome set of TCM for essential hypertension and improving the methodology quality of RCTs will help to accurately reflect the actual efficacy of TCM intervention.
