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| Analysis of the evaluation indexes of the efficacy of traditional Chinese medicine in gastric precancerous lesions in recent 20 years |
| Hits 193 Download times 107 Received:November 09, 2023 |
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| DOI
10.11656/j.issn.1673-9043.2024.04.07 |
| Key Words
gastric precancerous lesions;traditional Chinese medicine;evaluation index of curative effect;randomized controlled trial;core outcome set |
| Author Name | Affiliation | E-mail | | ZHANG Qingqing | Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China | | | WU Di | Department of Spleen and Gastroenterology, The First Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China | | | WANG Yichen | Department of Spleen and Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China | | | GUO Fengyun | Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China | | | YANG Shengnan | Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China | | | WANG Ping | Department of Spleen and Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China | celia_1224@163.com |
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| Abstract
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| [Objective] To systematically analyze the efficacy evaluation indexes of randomized controlled trials(RCTs) of traditional Chinese medicine(TCM) in the treatment of gastric precancerous lesions. [Methods] RCTs of TCM for gastric precancerous lesions were searched in the databases of China Journal Full Text Database,Wanfang Data,Wipo Database,PubMed and Embase,etc.,and the timeframe of the search was from 2001 to 2022. Referring to the Cochrane Handbook of Evaluation Criteria for Interventional Trial Studies combined with expert opinions to determine the study inclusion criteria,we extracted the methods of efficacy evaluation,established the database,and performed statistical analysis. [Results] A total of 887 RCTs were included,involving 7 index domains:gastroscopic mucosal manifestation,pathology,symptoms,evidence,serology,quality of survival,and safety,in which the indexes in the categories of pathology(71.36%) and gastroscopic mucosal manifestation(37.54%) were more frequently applied. Containing 20 kinds of integral methods,which belonged to the four parts of gastroscopy,pathology,symptom,and evidence,the higher-used integral methods were,in order,effective rate(43.63%),total integral(11.99%),and single-symptom integral(25.86%),and some of the studies[46 articles of gastroscopy(5.19%),135 articles of pathology(15.22%),105 articles of symptom(11.84%)] only pointed out the use of integral methods without specifying them. indicated the use of a scoring method without specifying how the scoring was performed. [Conclusion] At present,the evaluation indexes of gastric precancerous lesion efficacy have the problems of insufficient attention to gastroscopic and pathological indexes,lack of rigor in the selection of single indexes,lack of standardization in the application of composite indexes,lack of uniformity in the integration method of indexes,insufficient safety indexes,and lack of applicability in the quality of life indexes. In the future,when designing the efficacy evaluation scheme for gastric precancerous lesions,we should consider various aspects and establish a comprehensive evaluation system that combines gastroscopic indicators,patient symptoms,quality of life and other indicators,so as to normalize and standardize the design of clinical efficacy trials and improve the authenticity and reliability of research results. |
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