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| Analysis of the current status of the past five years clinical research ending indicators of traditional Chinese medicine treatment of shoulder periarthritis |
| Hits 388 Download times 359 Received:May 21, 2023 |
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| DOI
10.11656/j.issn.1672-1519.2023.08.15 |
| Key Words
Chinese medicine;frozen shoulder;clinical study;randomized controlled study;outcome indicators |
| Author Name | Affiliation | E-mail | | MAO Zefang | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Medical Research Center for Acupuncture and Moxibustion, Tianjin 300381, China | | | WANG Haiteng | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Medical Research Center 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 | | | WANG Xiaoyu | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Medical Research Center for Acupuncture and Moxibustion, Tianjin 300381, China | | | FAN Shun | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Medical Research Center for Acupuncture and Moxibustion, Tianjin 300381, China | | | WANG Yikun | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Medical Research Center for Acupuncture and Moxibustion, Tianjin 300381, China | | | WU Qiujun | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Medical Research Center for Acupuncture and Moxibustion, Tianjin 300381, China | | | ZHANG Haining | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Medical Research Center for Acupuncture and Moxibustion, Tianjin 300381, China | | | WANG Jingui | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Medical Research Center 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 evaluate the selection and application of outcome indicators in randomized controlled trial(RCT) of clinical studies of Chinese medicine for the treatment of frozen shoulder in the past five years,and to provide a basis for the establishment of a set of outcome indicators with evidential efficacy characteristics that can reflect the effectiveness of syndrome differentiation and treatment of Chinese medicine. [Methods] The Chinese and English databases such as such as CNKI,Wanfang Data knowledge service platform,VIP,China biomedical literature service system,PubMed and Cochrane library were systematically searched to describe the application of outcome indicators for the RCTs included in the study by screening the literature,extracting information and evaluating the risk of bias,using a qualitative analysis. [Results] A total of 108 RCTs were included,and their outcome indicators were classified into six categories according to their functional properties:symptoms and signs,quality of life,Chinese medicine symptoms,physical and chemical examination,safety,and long-term prognosis,of which the most frequently used were 86 items with a total effective rate of 79.62%,96 items with a pain level of 88.69%,visual analogue scale(VAS) 63 items 58.33% and 26 items with a short-form McGill Pain Questionnaire(SF-MPQ). 58.33% on the visual analogue scale,26 items(24.07%) on the Short-Form McGill Pain Questionnaire(SF-MPQ),81 items(75.00%) on the shoulder function(41.67% on the Constant-Murley Shoulder Assessment Scale(45 items) and 12.04 on the shoulder mobility ROM score(13 items),and 30 items on the laboratory indicators(27.78%). [Conclusion] In clinical research,traditional Chinese medicine (TCM) plays an important role in the treatment of scapulohumeral periarthritis. However,in the evaluation of efficacy,the diversity of outcome measures can affect the applied value of the study results. It is necessary to construct a syndrome efficacy index set that must be reported,uniform,standardized and reflect the effects of syndrome differentiation and treatment interventions. Before conducting research and design in this area,it is necessary to strengthen the methodological quality of research,fully consider factors related to TCM syndromes when incorporating diseases,and design more practical RCTs with TCM features. In the evaluation system for the clinical efficacy of TCM,it is necessary to properly select the outcome indicators,improve the corresponding evaluation methods,and improve the efficiency of TCM clinical research under the guidance of the basic TCM theory. |
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