Objective:To evaluate whether the traditional Chinese medicine (TCM) theory of five circuits and six qi (FCSQ) is beneficial in terms of improving clinical effectiveness.Methods:Randomized controlled trials (RCTs) evaluating the clinical value of FCSQ theory were reviewed.Multiple databases (China Network Knowledge Infrastructure,Chinese Scienti fic Joals Database,Wanfang Data,SinoMed,Cochrane Library,PubMed,and Embase) weresystematically searched from inception to June 12,2018.Two authors independently extracted the data and performed a methodological quality assessment of the RCTs.RevMan 5.3 software was used for the data analysis.The effect sizes for the primary outcome measures were expressed as relative risks or mean differences with 95％ confidence intervals.Results:A total of 13 RCTs were selected,involving 12 types of diseases and 4695 patients.The methodological quality of the RCTs was generally low.Five studies compared the effectiveness of TCM treatments guided by FCSQ theory with conventional TCM therapies,and the remaining eight studies compared the effectiveness of TCM treatments guided by FCSQ theory with biomedical treatments.All of the RCTs reported that the effectiveness of the treatment intervention was better than that of the intervention in the control group.Conclusion:Because of many methodological problems in existing clinical studies,it remains impossible to definitively conclude that FCSQ theory can improve clinical effectiveness.It is difficult to unify the clinical application of FCSQ theory.The feasibility and repeatability of FCSQas an intervention should be given more attention in future clinical research.Future work should also follow intational norms for clinical research implementation and reporting to provide high-quality evidence for evaluating the clinical value of FCSQ theory.