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| Analysis of the outcome indicators of randomized clinical trials in treatment of menopausal transition on traditional Chinese medicine in 2019-2021 |
| Hits 462 Download times 253 Received:July 10, 2022 |
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| DOI
10.11656/j.issn.1672-1519.2022.11.10 |
| Key Words
traditional Chinese medicine;menopausal transition;randomized controlled trial;outcome indicator |
| Author Name | Affiliation | E-mail | | AI Yanke | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | LI Yang | Beijing Fengtai You'anmen Hospital, Beijing 100054, China | | | ZHAO Tianyi | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | SUN Haishu | Institute of Chinese Medicine Information, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | GE Zhishan | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | CAO Xue | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | YU Xueyun | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | ZHANG Yanhong | Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | WU Dongning | Xidan Clinic of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100032, China | | | LIU Baoyan | Traditional Chinese Medicine Data Center, China Academy of Chinese Medical Sciences, Beijing 100070, China | | | HE Liyun | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | hely3699@163.com | | LIU Jia | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | marie_liujia@sina.cn |
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| Abstract
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| [Objective] To evaluate the outcome indicators in the randomized controlled trial of traditional Chinese medicine(TCM) for menopausal transition and to provide the references for the future researches of core outcome set.[Methods] Randomized controlled trials (RCTs) of TCM in the treatment of menopausal transition were collected in the database of CNKI,WanFang,VIP,PubMed,Embase and Cochrane library from January 2019 to December 2021.According to the inclusion and exclusion criteria,two evaluators independently screened the literature,extracted the data and described the use of outcome indicators of the included RCTs.[Results] The 47 RCTs were included and a total of 38 efficacy outcomes were used and the top five efficacy outcomes were the clinical curative effect of treatment with frequency of 30 times(64%),hormone level with frequency of 26 times (55%),the modified Kupperman index with frequency of 18 times(38%),TCM symptom score with frequency of 15 times (32%) and PSQI scale with frequency of 14 times (30%). The 35 RCTs used global efficacy evaluation outcomes,68%of the included RCTs were evaluated at two time points (before and after of the treatment) and 85% of studies were followed within 3 months.[Conclusion] Considerable heterogeneity existed in the selection,measurement and reporting of outcomes indicators in RCTs of TCM for menopausal transition and it is necessary to conduct research on core outcome set and establish the evaluation system of efficacy indicators for patient reports and doctor reports in accordance with the characteristics of TCM. |
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