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| Analysis of the current status of outcome indicators in a randomised controlled trial of acupuncture for primary dysmenorrhea |
| Hits 392 Download times 281 Received:November 05, 2024 |
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| DOI
10.11656/j.issn.1673-9043.2025.05.08 |
| Key Words
acupuncture;primary dysmenorrhoea;randomised controlled trial;outcome indicator;core outcome set;RoB2.0 |
| Author Name | Affiliation | E-mail | | ZHANG Jiacheng | Department of Tuina, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Medical Research Centre for Acupuncture and Moxibustion, Tianjin 300381, China
Graduate School of Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | MAO Zefang | Department of Tuina, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Medical Research Centre for Acupuncture and Moxibustion, Tianjin 300381, China
Graduate School of Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Xiaoyu | Department of Tuina, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Medical Research Centre for Acupuncture and Moxibustion, Tianjin 300381, China
Graduate School of Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | LIU Gaoxinli | Department of Tuina, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Medical Research Centre for Acupuncture and Moxibustion, Tianjin 300381, China
Graduate School of Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | SU Zhichao | Department of Tuina, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Medical Research Centre for Acupuncture and Moxibustion, Tianjin 300381, China
Level Ⅲ Laboratory of Biological Effects of Tui Na Manipulation, State Administration of Traditional Chinese Medicine, Tianjin 300381, China | | | NING Jing | Department of Tuina, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Medical Research Centre for Acupuncture and Moxibustion, Tianjin 300381, China
Graduate School of Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Jingui | Department of Tuina, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Medical Research Centre for Acupuncture and Moxibustion, Tianjin 300381, China
Level Ⅲ Laboratory of Biological Effects of Tui Na Manipulation, State Administration of Traditional Chinese Medicine, Tianjin 300381, China | wjg65tj@163.com |
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| Abstract
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| [Objective] To analyse the current status of the use of outcome indicators in randomized controlled trials（RCTs） of acupuncture for primary dysmenorrhea（PD），in order to provide a basis for future clinical studies on acupuncture for PD and for the construction of a core set of indicators. [Methods] China Knowledge Network（CNKI），Wanfang Data Knowledge Service Platform（Wangfang），Wipro Chinese Journal Database（VIP），China Biomedical Literature Service System（SinoMed），PubMed，EMbase，Cochrane Library，and Web of Science databases were searched for articles published from 1 January 2014 to 19 March 2024，RCTs on acupuncture for PD，were extracted，classified and analysed for their outcome indicators to form an indicator domain for acupuncture for PD. [Results] A total of 56 studies were included，with a total of 49 outcome indicators and a frequency of 172 uses. In the order of frequency of the outcome indicators，the indicator domains they belonged to were symptoms/signs（64.53%），physical and chemical examination（18.60%），long-term prognosis（11.63%），safety events（2.91%），quality of life（2.33%），satisfaction indicators（1.16%），and traditional Chinese medicine（TCM） illnesses（0.58%），and no economic indicators were reported in any of the included studies. [Conclusion] The current status of the use of outcome indicators exists a high risk of bias，methodological quality to be improved，unclear distinction between primary/secondary outcome indicators，over-reliance on subjective outcome indicators，lack of objective outcome indicators，neglect of indicators of Chinese medical conditions，failure to reflect the characteristics of TCM，neglect of the evaluation of the quality of life，and the lack of indicators of the evaluation of economics，in the future，we should accelerate the construction of the core set of indicators of PD treated by acupuncture to improve the RCT quality and recognition，and maximise the value of individual RCTs. |
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