Peptic ulcer (PUD) is a common disease of the digestive system. Traditional Chinese Medicine (TCM) treatment is an effective treatment for PUD. However, in the randomized controlled trials (RCTs) of TCM treatment of this disease, there are great limitations in the selection of methodological quality and outcome indicators, which brings some challenges to efficacy evaluation and data integration analysis.

To systematically review the application status and experimental design points of RCTs outcome indicators of TCM intervention in PUD in the past 15 years, aiming to provide reference for the construction of core indicator set of TCM treatment of PUD and the optimization of clinical trial design.

Computerized searches were conducted in Chinese databases: CNKI, Wanfang Data, VIP, and SinoMed, as well as international authoritative databases: PubMed, Embase, Cochrane Library, and Web of Science for RCTs on the treatment of PUD with TCM. The search time frame was from 2010 to 2024. Cochrane bias risk assessment was performed on the included literature, and relevant outcome indicators were counted, summarized and analyzed.

A total of 323 RCTs with 34 933 patients were included. The maximum sample size of single study was 498 cases, the minimum was 40 cases, and the average sample size was 108 cases. Among the 171 reports of TCM syndromes, the highest frequency of use was spleen and stomach deficiency cold (31 articles, 18.13%); 47 articles were treated with pure TCM, and 276 articles were treated with integrated Traditional Chinese and Western Medicine. The course of treatment was mostly 4 weeks (119 times, 36.84%); the outcome indicators were divided into 6 categories according to functional attributes. A total of 170 outcome indicators were reported, with a total frequency of 1 962 times. The outcome indicators with higher frequency of use were total clinical effective rate (233 times, 11.88%), Helicobacter pylori eradication rate (165 times, 8.41%), and adverse reactions (155 times, 7.90%). The risk assessment of bias in the included literature was not clear.

The RCTs of PUD treated with TCM still exist in the following aspects: the dialectical classification and disease staging of TCM are not standardized, the methodological design (blind method, distribution concealment) needs to be improved, the primary and secondary outcome indicators are not clearly distinguished, the clinical efficacy standards are not unified, the measurement time gap of outcome indicators is large, the scoring criteria of TCM syndromes/symptoms is diversified, the ethical registration needs to be paid attention to, and the report of safety indicators is not standardized. It is suggested to actively carry out the research on the core index set of TCM treatment of PUD, optimize and improve the methodological quality, and provide high scientific, reliable and practical evidence for the clinical practice of TCM treatment of PUD.

消化性溃疡（PUD）是消化系统常见疾病，中医药治疗作为PUD的有效治疗措施，但目前针对中医药治疗PUD的随机对照试验（RCT）中，方法学质量、结局指标的选择等存在较大局限性，给疗效评价、资料整合分析等带来一定挑战。

本文系统梳理近15年中医药干预PUD的RCT结局指标应用状况与试验设计要点，旨在为构建中医药治疗PUD核心指标集及优化临床试验设计提供参考依据。

计算机检索中文数据库：中国知网、万方数据知识服务平台、维普网、中国生物医学文献服务系统，以及国际权威数据库：PubMed、Embase、Cochrane Library、Web of Science中关于中医药治疗PUD的RCT文献；检索时限为2010—2024年。对纳入文献进行Cochrane偏倚风险评估，并统计、归纳、分析相关结局指标。

共纳入323篇RCT文献，34 933例患者，单项研究样本量最大为498例，最小为40例，平均样本量为108例；171篇报告中医证型，其中使用频次最高为脾胃虚寒（31篇，18.13%）；47篇采用纯中医治疗，276篇采用中西医结合治疗；治疗疗程多为4周（119次，36.84%）；结局指标按照功能属性划分为6类，共报道了170种结局指标，总频次为1 962次，其中使用频次较高的结局指标是临床总有效率（233次，11.88%）、幽门螺杆菌根除率（165次，8.41%）、不良反应（155次，7.90%）；纳入文献偏倚风险评估多数为不明确。

中医药治疗PUD的RCT尚存在中医辨证分型与疾病分期欠规范、方法学设计（盲法、分配隐藏）待完善、主次结局指标区分不明确、临床疗效标准未统一、结局指标测量时间差距大、中医证候/症状积分评分标准多元化、伦理注册待重视、安全性指标报告不规范等问题。建议积极开展中医药治疗PUD的核心指标集研究，优化完善方法学质量，为中医药治疗PUD的临床实践提供科学性、可靠性、实用性证据。