Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China.
Department of Spleen and Gastroenterology, the First Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China.
Zhejiang Da Xue Xue Bao Yi Xue Ban. 2023 Oct 6;52(5):636-645. doi: 10.3724/zdxbyxb-2023-0072.
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 RCTs on traditional Chinese medicines for gastric precancerous lesions were searched from the CNKI, Wanfang database, VIP, 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 evaluation 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 risk of uncertainty for the allocation scheme concealment was 98.93%; the risk of uncertainty for blinding of patients or testers was 98.69%; the risk of uncertainty 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 98.45%. The CONSORT statement evaluating the quality of reporting showed that 100.00% of the RCT articles reported the 8 entries; 36.79% of the literature mentioned the method of randomized sequence generation, but only 27.62% of the literature mentioned who implemented the randomized program, 1.07% of the literature hid the randomized program and 1.31% of the studies were 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.
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 for 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.
评价近 20 年来中医药治疗胃癌前病变的随机对照试验（RCT）的方法学质量。
检索中国知网、万方数据库、维普、PubMed、Embase 自 2001 年 1 月至 2021 年 12 月发表的中医药治疗胃癌前病变的 RCT，按照 2010 年 CONSORT 声明、Cochrane 偏倚风险评估工具及补充评价指标进行筛选、提取和评价。
共纳入 840 篇文献。根据 Cochrane 偏倚风险评估工具，随机方法应用的高偏倚风险为 5.95%；分配方案隐藏的不确定风险为 98.93%；患者或测试者盲法的不确定风险为 98.69%；结局评估者盲法的不确定风险为 100.00%；结局数据完整性的偏倚风险为 2.86%；选择性报告的不确定风险为 98.45%。报告质量的 CONSORT 评价显示，100.00%的 RCT 文献均报告了 8 项条目；36.79%的文献提及随机序列生成方法，但仅 27.62%的文献提及谁执行了随机方案，1.07%的文献隐藏了随机方案，1.31%的研究采用盲法；36.67%的文献报告了不良反应；没有文献报道样本量预测方法。补充评价指标显示，17.02%的研究获得了伦理批准；43.81%的文献指定了中药证据；16.55%的研究排除了严重的异型增生；7.26%的研究进行了随访；65.12%的文献采用了综合疗效指标；46.67%的文献应用了病理组织学评价；2.62%的文献应用了生活质量评价。
中医药治疗胃癌前病变的 RCT 整体偏倚风险较高，大部分研究报告的质量有待提高。未来需要加强 RCT 的研究设计，参考适宜的中药证据分级标准，根据不同目的选择研究方案，为中药临床研究提供客观、有力的证据，并按照 CONSORT 原则开展适合中药的临床研究设计和结果报告。
