Situation analysis of outcome indicators of randomized controlled trials of traditional Chinese medicine in treatment of hypertensive intracerebral hemorrhage in recent three years.
10.19540/j.cnki.cjcmm.20210618.501
- Author:
Wan-Qing DU
1
;
Min JIA
2
;
Min WANG
3
;
Xin-Yang ZHANG
3
;
Wei-Wei JIAO
2
;
Qian CHEN
3
;
Lin LEI
3
;
Jia-Yu DUAN
3
;
Chen-Guang TONG
2
;
Wei SHEN
2
;
Xiao LIANG
2
;
Xin-Zhi CHEN
4
;
Da-Hua WU
5
;
Yun-Ling ZHANG
2
;
Xing LIAO
6
Author Information
1. Graduate School,Beijing University of Chinese Medicine Beijing 100029,China Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China Xiyuan Hospital,China Academy of Chinese Medical Sciences Beijing 100091,China.
2. Xiyuan Hospital,China Academy of Chinese Medical Sciences Beijing 100091,China.
3. Graduate School,Beijing University of Chinese Medicine Beijing 100029,China.
4. the First Clinical Hospital of Jilin Academy of Chinese Medical Sciences Changchun 130021,China.
5. Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine Changsha 410006,China.
6. Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China.
- Publication Type:Journal Article
- Keywords:
hypertensive intracerebral hemorrhage;
limitation;
outcome indicator;
randomized controlled trial;
traditional Chinese medicine
- MeSH:
Drugs, Chinese Herbal/therapeutic use*;
Humans;
Intracranial Hemorrhage, Hypertensive/drug therapy*;
Medicine, Chinese Traditional;
Quality of Life;
Randomized Controlled Trials as Topic
- From:
China Journal of Chinese Materia Medica
2021;46(18):4601-4614
- CountryChina
- Language:Chinese
-
Abstract:
The study aims to analyze the outcome indicators of randomized controlled trial(RCT) of traditional Chinese medicine(TCM) in the treatment of hypertensive intracerebral hemorrhage(HICH) in recent three years, and thus provide suggestions for the future studies in this field. Four English databases, four Chinese databases and two online registration websites of clinical trials were searched. The RCTs published between January 2018 and September 2020 were screened. The risk of bias was assessed and outcome measures were classified. A total of 151 839 articles were retrieved, of which 44 RCTs were included for analysis after screening. The outcome measures of the included RCTs were classified into 7 categories, among which the symptoms/signs category showed the highest reporting rate. National Institute of Health stroke scale(72.73%) was the most frequently reported outcome indicator, while the vo-lume of intracerebral hemorrhage determined by computerized tomography(36.36%) was the most frequently reported lab test outcome. Most studies collect the outcomes at the end of treatment, while 9 studies reported long-term outcomes 3 months or more after onset. Compared with those of international clinical trials, the application of some of the outcomes was reasonable, focusing on patients' symptoms, quality of life and objective outcomes. However, there were still several problems: unclear primary and secondary outcome measures, insufficient attention to long-term prognosis, insufficient attention to social function, few TCM outcomes, lack of measurement blindness and the use of unreasonable composite outcomes. It is recommended that researchers should rationally design the outcome indicators of clinical trials and develop the core outcome set.
