Objectives: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
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月中国知网、万方数据、维普网、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版CONSORT声明、Cochrane偏倚风险评估量表及与疾病相关附加评价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风险不确定为98.69%；结果评估者施盲的风险不确定为100.00%；结果数据完整性高风险占2.86%；选择性报告的风险不确定为98.45%。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%的文献交代了随机序列产生方法，但仅有27.62%的文献交代了实施随机方案的人员，1.07%的文献隐藏了分配方案，1.31%的文献采用盲法；36.67%的文献报告了不良反应；没有文献报告样本量预估方法。与疾病相关附加评价指标分析结果显示，17.02%的文献通过研究的伦理学审查；43.81%的文献指定中医证型；16.55%的文献排除重度异型增生；7.26%的文献有随访资料；65.12%的文献采用复合疗效指标；46.67%的文献应用组织病理学评价；2.62%的文献运用生活质量评价等。结论: 中医药治疗胃癌前病变的临床RCT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。.
Keywords: Gastric precancerous lesions; Literature study; Quality evaluation; Randomized controlled trial; Traditional Chinese medicine.