| Objective:Through meta-analysis,this study objectively evaluate the exact curative effect and adverse reactions of using traditional Chinese medicine(TCM)in the treatment of delayed menstruation,as well as summarize the syndromes,decoctions and herbs included in the literature,in order to seek a better method for the treatment of delayed menstruation,and hope to provide a theoretical basis and clinical reference for the treatment of delayed menstruation with traditional Chinese medicine in the future,so that it can be standardized and popularized to all clinical medical applications.Method:Randomized controlled trials related to the treatment of delayed menstruation with traditional Chinese medicine(TCM)were obtained from various databases by using computer network queries,namely China National Knowledge Infrastructure(CNKI),Wanfang Data,China Biology Medicine(CBM),VIP,PubMed,Embase,Cochrane Central Register of Controlled Trials from the establishment of the databases to December 20,2018.The retrieved literature was loaded into the software Endnote X7 for review,eliminating repeated studies,and further screening according to inclusion and exclusion criteria.Endnote X7 and Excel 2010 were used to extract data and Reviews Manager 5.3.5 and Cochrane Bias Risk Assessment Tools were used to evaluate the risk of bias of the included randomized controlled trials.Heterogeneity analysis,analysis of combination effects,sensitivity analysis and funnel plot analysis were performed on the efficacy indicators.Results:A total of 18 clinical randomized controlled trials were included,with 1461 subjects.No high-risk studies were found in the included literature,with good overall quality and high credibility,and no significant publication bias.Meta-analysis results suggest that after treatment,the curative effect of traditional Chinese medicine is better than that of Western medicine.(1)The difference in the total effective rate[RR(95%CI)= 1.20(1.13,1.28),P<0.0001],cure rate[RR(95%CI)=1.39(1.14,1.70),P=0.001]and markedly effective rate[RR(95%CI)=1.34(1.08,1.66),P=0.009]of the curative effect of regulating menstruation was statistically significant;while the difference in the effective rate[RR(95%CI)=0.96(0.79,1.18),P=0.71]was not statistically significant.(2)The difference in the total effective rate[RR(95%CI)= 1.37(1.02,1.85),P=0.04]and markedly effective rate[RR(95%CI)=2.79(1.53,5.10),P=0.0008]of the curative effect of TCM syndrome had statistical significance;whereas the difference in the cure rate[RR(95%CI)=2.14(0.63,7.22),P=0.22]and effective rate[RR(95%CI)=1.00(0.61,1.67),P=0.99]did not have statistical significance.(3)The score of TCM syndrome was significantly lower than that of Western medicine[SMD(95%CI)=-1.14(-1.45,-0.84),P<0.00001]and the difference was statistically significant.(4)TCM treatment has better and lasting curative effect than Western medicine in improving menstrual cycle[SMD(95%CI)=-0.55(-1.09,-0.01),P=0.05]and improving dysmenorrhea[SMD(95%CI)=-1.06(-2.00,-0.12),P=0.03],and the difference had statistical significane.TCM also has better curative effect than Western medicine in improving symptoms such as breast swelling and pain[SMD(95%CI)=-1.16(-2.21,-0.10),P=0.03],soreness and weakness of waist and knees[SMD(95%CI)=-2.09(-3.90,-0.27),P=0.02],anxiety and irritability[SMD(95%CI)=-0.48(-0.86,-0.10),P=0.01],and the difference had statistical significance,while there was no significant difference in other clinical symptoms.(5)In the aspect of improving hormone levels such as E2[WMD(95%CI)= 12.87(4.20,21.54),P=0.004],LH[WMD(95%CI)=0.52(0.03,1.02),P=0.04],PRL[WMD(95%CI)=-1.41(-2.79,-0.03),P=0.05],AMH[WMD(95%CI)=1.74(0.36,3.13),P=0.01],TCM treatment has a significant curative effect and the difference was statistically significant;whereas the difference in P[WMD(95%CI)=0.06(-0.24,0.36),P=0.70],FSH[WMD(95%CI)=0.38(-0.28,1.04),P=0.26],FSH/LH[WMD(95%CI)=-0.17(-0.41,0.08),P=0.17]was not statistically significant.(6)In terms of adverse reactions,the incidence of TCM treatment was significantly lower than that of Western medicine treatment[RR(95%CI)= 0.11(0.05,0.25),P<0.00001],with statistical significance.(7)For the delayed menstruation of hyperprolactinemia(HPRL),TCM had better curative effect than Western medicine after treatment,in the aspect of the total effective rate and cure rate of the curative effect of regulating menstruation,score of TCM syndrome,hormone levels such as E2 and PRL,and the difference had statistical significance;whilst the difference between the markedly effective rate and effective rate of curative effect of regulating menstruation,and the hormone levels of FSH and LH did not have statistical significance.(8)Meta-analysis results suggest that after 3 months of follow-up,TCM had better curative effect than that of Western medicine,in the aspect of the markedly effective rate of curative effect of regulating menstruation[RR(95%CI)= 1.83(1.07,3.12),P=0.03],the markedly effective rate of curative effect of TCM syndrome[RR(95%CI)=4.01(1.69,9.49),P=0.002]and the score of TCM syndrome[SMD(95%CI)=-1.24(-1.69,-0.79),P<0.00001]with significant statistical difference.And the difference was not significant in other comparisons.(9)For the delayed menstruation of Polycystic Ovary Syndrome(PCOS),after 3 months of follow-up,traditional Chinese medicine has better performance than Western medicine in the aspects of the total effective rate and markedly effective rate of the curative effect of regulating menstruation,the total effective rate,markedly effective rate and effective rate of the curative effect of TCM syndrome,score of TCM syndrome,and the difference had statistical significance;whereas the difference was not significant in the cure rate and effective rate of curative effect of regulating menstruation,and the cure rate of curative effect of TCM syndrome.(10)According to the literature,it is found that the main syndrome of the disease is kidney deficiency.Among the 18 prescriptions,the most commonly used drug was herbs which can reinforce kidney.In the treatment of delayed menstruation,herbs which tonify the kidney,strengthen qi,promote blood circulation and soothe liver were used mainly,combined with those which nourish the heart,tranquilize the mind,regulate qi and remove phlegm.Conclusion:Meta-analysis results show that traditional Chinese medicine has better performance than Western medicine in treating delayed menstruation.It can improve the total effective rate,cure rate and markedly effective rate of the curative effect of regulating menstruation after treatment,the total effective rate and markedly effective rate of the curative effect of TCM syndrome,also it can reduce the score of TCM syndrome and improve TCM clinical symptoms(i.e.menstrual cycle,dysmenorrhea,breast swelling and pain,soreness and weakness of waist and knees,anxiety and irritability),and improve the hormone levels(i.e.estradiol,luteinizing hormone,prolactin,anti-Mullerian hormone),and the incidence of adverse reactions is lower than that of Western medicine.In addition,after 3 months of follow-up,it can also improve the markedly effective rate of the curative effect of regulating menstruation and the markedly effective rate of the curative effect of TCM syndrome,and reduce the score of TCM syndrome.Through the analysis of syndrome type and medication rule of TCM,it is found that the disease is mainly caused by kidney deficiency.The most commonly used TCM herb is kidney-reinforcing herbs.In the treatment of delayed menstruation,TCM herbs which tonify kidney,strengthen qi,promote blood circulation and soothe liver are used,as well as those which nourish the heart,tranquilize the mind,regulate qi and remove phlegm.TCM has curative effect and advantages for the treatment of delayed menstruation,and it is safer.And TCM treamtnent is worthy for further clinical standardization and application. 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