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- W4387394351 abstract "To evaluate the methodological quality of randomized controlled trials (RCTs) of traditional Chinese medicines for the treatment of gastric precancerous lesions in the past 20 years.The studies of RCTs on traditional Chinese medicines for gastric precancerous lesions were searched from the Chinese full-text journal database, Wanfang database, VIP database, PubMed, and Embase from January 2001 to December 2021. The retrieved articles were screened, extracted and evaluated based on the 2010 edition of CONSORT statement, Cochrane Risk of Bias Assessment Scale and additional indicators.A total of 840 papers were included. According to the Cochrane Risk of Bias Assessment Scale, the high risk of bias in the application of randomized methods was 5.95%; the concealed risk of uncertainty in the allocation scheme was 98.93%; the low risk of bias for blinding of patients or testers was 1.30%; the risk of bias for blinding of the outcome assessor was 100.00%; the risk of bias for completeness of the outcome data was 2.86%; and the risk of uncertainty for selective reporting was 98.44%. The CONSORT statement evaluating the quality of reporting showed that 100.00% of the RCT articles reported the 8 entries of introduction, objectives and interventions; 36.79% of the literature mentioned the method of randomized sequence generation, but only 27.62% of the literature implemented a randomized program, 1.07% of the literature hid the randomized program and 1.31% of the literature was blinded; 36.67% of the literature reported adverse reactions; no literature reported sample size prediction methods; additional evaluation indicators showed that 17.02% of the studies had ethical approval; 43.81% of the literature specified Chinese medicine evidence; 16.55% of the studies excluded severe heterotrophic hyperplasia; 7.26% of the studies conducted follow-up; and 65.12% of the literature used composite efficacy indicators; 46.67% of the literature applied pathological histological evaluation; 2.62% of the literature applied quality of life evaluation, etc.The overall risk of bias in RCTs of traditional Chinese medicines for gastric precancerous lesions is high, and the quality of most of the study reports needs to be improved. In the future, it is necessary to strengthen the study design of RCTs and refer to appropriate traditional Chinese medicines evidence grading standards, select study protocols according to different purposes, provide objective and strong evidence of clinical studies on traditional Chinese medicines, and carry out clinical study design and result reporting suitable for traditional Chinese medicines according to the CONSORT principle.目的: 评价近二十年中医药治疗胃癌前病变临床随机对照试验(RCT)的方法学质量,为提升该疾病临床研究质量提供参考。方法: 检索2001年1月—2021年12月中国期刊全文数据库、万方数据库、维普数据库、PubMed和Embase中收录的中医药治疗胃癌前病变的临床RCT文献,经过筛选、信息提取,构建数据库,基于2010年版CONSORT声明、Cochrane偏倚风险评估量表及疾病相关附加指标对临床试验设计进行评价及分析。结果: 共纳入840篇文献。根据Cochrane偏倚风险评估量表,随机方法应用为高偏倚风险占5.95%;分配方案隐藏风险为不确定者占98.93%;患者或试验者施盲的低偏倚风险为1.30%;结果评估者施盲的高偏倚风险为100.00%;结果数据完整性的高偏倚风险占2.86%;选择性报告的风险不确定为98.44%。CONSORT声明评价报告质量结果显示,100.00%RCT文献报告了引言、目标和干预措施等8个条目;36.79%文献交代了随机序列产生方法,但仅有27.62%文献实施了随机方案,1.07%文献隐藏了随机方案,1.31%文献采用盲法;36.67%文献报告了不良反应;没有文献报告样本量预估方法;疾病相关附加指标评价结果,17.02%文献经过伦理学审批;43.81%文献指定中医证型;16.55%文献排除重度异型增生;7.26%文献有随访资料;65.12%文献采用复合型疗效指标;46.67%文献应用病理组织学评价;2.62%文献运用生活质量评价等。结论: 中医药治疗胃癌前病变的随机对照临床试验整体偏倚风险偏高,大部分研究报告质量有待提高。今后需要加强RCT研究设计,并参考适宜的中医证据分级标准,根据研究目的选用不同研究方案,提供客观有力的中医药临床研究证据,按照CONSORT原则进行适合中医药的临床研究设计及结果报告。." @default.
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- W4387394351 date "2023-10-01" @default.
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- W4387394351 title "Quality evaluation of the literature on randomized controlled clinical trials of traditional Chinese medicine for treatment of gastric precancerous lesions in last 20 years" @default.
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