Randomized controlled trial outcome indicators of postmenopausal osteoporosis treated by traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20210426.501
- Author:
Hui-Min LI
1
;
Wei YANG
2
;
Yi-Li ZHANG
3
;
Ying-Jie ZHI
2
Author Information
1. Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
2. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
3. Beijing University of Chinese Medicine Beijing 100029, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
core outcome set;
outcome indicator;
postmenopausal osteoporosis(PMOP);
randomized controlled trial(RCT);
traditional Chinese medicine(TCM)
- MeSH:
Bone Density;
Drugs, Chinese Herbal/therapeutic use*;
Female;
Humans;
Medicine, Chinese Traditional;
Osteoporosis, Postmenopausal/drug therapy*;
Quality of Life;
Treatment Outcome
- From:
China Journal of Chinese Materia Medica
2021;46(16):4274-4286
- CountryChina
- Language:Chinese
-
Abstract:
This study evaluated the outcome indicators of the randomized controlled trials(RCTs) of traditional Chinese medicine(TCM) in the treatment of postmenopausal osteoporosis(PMOP) to provide a reference for the related research. Four Chinese databa-ses(CNKI, VIP, Wanfang and CBM) and three English databases(Cochrane Library, EMbase and PubMed) were searched syste-matically to screen RCTs of TCM in the treatment of PMOP according to the pre-set criteria, and the quality of the included trials was evaluated by the Cochrane risk-of-bias tool. A total of 29 627 articles were initially retrieved, and finally, 43 articles were included, including 34 in Chinese and 9 in English. As revealed by the results, the outcome indicators of 43 RCTs were mainly divided into six categories, with biochemical indicators accounting for 54.59%, bone mineral density(BMD) for 26.57%, quality of life for 6.28%, fracture for 1.94%, safety for 5.31%(including adverse reactions or events) and others for 5.31%. Biochemical indicators showed the maximum occurrence, followed by BMD. Many problems were found in the selection of outcome indicators of the TCM RCTs in the treatment of PMOP, such as the confusion of primary and secondary outcome indicators, the lack of endpoint criteria and vital clinical outcome indicators substituted by intermediate indicators, inconsistent evaluation standard of syndrome curative efficacy and neglected blinding in the measurement of subjective outcome indicators. The problems also included importance given to the efficacy indicators instead of the adverse outcome indicators, unnormalized indicator name, large quantitative range of the indicators, unconventional application of TCM efficacy criteria, seldom used confidence interval, relative effect indicator and absolute effect indicator.
