Analysis on selection status of RCT outcome indicators of TCM for the treatment of adenomyosis
10.3760/cma.j.cn115398-20221102-00047
- VernacularTitle:中医药治疗子宫腺肌病随机对照试验结局指标选用现状分析
- Author:
Yinuo ZHANG
1
;
Yinuo CHEN
;
Xin WANG
;
Yang LIU
;
Wei SHI
Author Information
1. 山东中医药大学中医学院，济南 250355
- Keywords:
Adenomyosis;
TCM;
Outcome indicators;
Randomized controlled trial;
Core outcome set
- From:
International Journal of Traditional Chinese Medicine
2023;45(12):1582-1588
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the selection status of randomized controlled trial (RCT) outcome indicators of TCM for the treatment of adenomyosis (AM) in the past five years; To provide suggestions for the future studies in this field.Methods:The RCTs of TCM for the treatment of AM were retrieved from the databases of CNKI, Wanfang Data, VIP, CBM, PubMed, Embase, the Cochrane Library, Web of Science, Chinese Clinical Trial Register and ClinicalTrials from the establishment of the database to February 28, 2022. The risk of bias was assessed, and the outcome indicators were classified, described and analyzed, and compared with the international core outcome set (COS) studies.Results:A total of 48 studies were included, of which 47 were from published literature and 1 was from registered clinical trials, involving 4 544 patients and 77 outcome indicators. Among the 47 literatures, the total clinical efficacy rate (63.83%) was the most frequently reported outcome indicator, followed by uterine volume (61.70%). Ultrasound examination was the main outcome index in 1 registered trial. Compared with the international COS study, it was found that the included studies paid attention to the outcome report of pain degree, menstrual status and hematological indicators, the reporting rate of quality of life and economic indicators was low, and the urinary system symptoms and fertility outcome indicators were not reported.Conclusion:In the selection of outcome indicators, RCTs of TCM treatment of AM pay attention to the symptoms and signs outcomes, physical and chemical examination outcomes. However, there were still several problems of the selection of outcome measures: unclear primary and secondary outcome indicator, the use of unreasonable composite outcomes, lack of measurement blindness, insufficient attention to endpoint criteria, and ignoring economic evaluation.
