Analysis on the Current Status of Outcome Indicators and Measurement Tools in Clinical Studies of TCM Treatment for Polycystic Ovary Syndrome
10.19879/j.cnki.1005-5304.202403241
- VernacularTitle:中医药治疗多囊卵巢综合征临床研究结局指标与测量工具现状分析
- Author:
Renbin SU
1
;
Bohan NIU
;
Ping CHEN
;
Yixin WANG
Author Information
1. 河南中医药大学第一附属医院,河南 郑州 450000
- Keywords:
polycystic ovary syndrome;
TCM;
clinical research;
outcome indicators;
core outcome set
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2024;31(9):66-72
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the outcome indicators in clinical research on TCM treatment for polycystic ovary syndrome(PCOS);To provide a theoretical basis for establishing the PCOS clinical core outcome indicator set.Methods Relevant clinical research about TCM treatment for PCOS was retrieved from CNKI,Wanfang Data,VIP,CBM,Embase,PubMed,Web of Science and Cochrane Library from 1st,Jan.2019 to 15th,Nov.2023.Research articles were screened based on predefined inclusion and exclusion criteria,and a comprehensive analysis was conducted on the extracted data.Results A total of 951 clinical studies were included(915 in Chinese and 36 in English),involving 86 369 patients,with 221 outcome indicators identified,and a total frequency of 8 991 occurrences.Analysis revealed that commonly used outcome indicators included hormone levels(such as luteinizing hormone,follicle-stimulating hormone,testosterone),overall efficacy rate,ovulation rate,pregnancy rate,TCM syndrome score,ovarian volume and insulin resistance index.However,there was considerable variation in the choice of indicators across different studies,and some indicators were misaligned with clinical needs,lacking a focus on long-term prognosis and safety.Conclusion Clinical research on TCM treatments for PCOS often demonstrates significant variability in outcome indicators,lack of clarity between primary and secondary indicators,disorganized description of indicators,diversity in the choice of measurement tools,and a lack of indicators for specific populations.These problems lead to difficulties in combining similar studies for meta-analysis and fail to provide high-level evidence-based clinical guidance.There is an urgent need to establish a core set of outcome indicators for clinical research on TCM treatment for PCOS.
