Abstract:Objective:To systematically evaluate the clinical effects and safety of Chinese Medicine in treating human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS)-related diarrhea (HRD),and to evaluate the quality of evidence by GRADE. Methods:Chinese and English databases such as China National Knowledge Infrastructure (CNKI) and PubMed, as well as clinical trial registration platforms, were used to search for randomized controlled trials of Chinese medicine treatment for HRD (retrieval time from the establishment date of each database to March 31,2023). Data retrieval, data extraction, bias risk assessment, and Meta-analysis were conducted by two researchers independently. Results: Ultimately, 31 papers and one clinical study with 3 474 patients were included, involving 1 830 cases in the trial group and 1 644 cases in the control group. The Meta-analysis results showed that Chinese medicine treatment can significantly improve the clinical efficacy of HRD patients, reduce the scores of stool frequency, diarrhea disappeared time, traditional Chinese medicine symptom scores, diarrhea scale scores, and abdominal pain scores, and increase body mass. No publication bias was found in the clinical effective rates and traditional Chinese medicine symptom scores. The GRADE evidence quality rating results showed that Chinese medicine symptom scores, stool frequency scores, and absolute CD4+ T cell count are high-level quality evidence;the clinical effective rate,diarrhea recovery time,diarrhea scale scores,abdominal pain scores,the incidence of adverse reactions,and body mass are intermediate quality evidence; the clinical effective rates of traditional Chinese medicine syndrome is low-quality evidence. Conclusion:Chinese medicine can improve the clinical efficacy of HRD patients and alleviate clinical symptoms of diarrhea, with good safety. It is recommended for the treatment of HRD. However, due to the low quality of the research methods included and the low quality evidence of some outcome indexes, more rigorously designed multicenter randomized controlled trials are needed to increase the strength of evidence.