Meta Analysis Of Traditional Chinese Medicine In The Treatment Of Premature Ovarian Insufficiency And Premature Ovarian Failure In Recent 10 Years

Objective:This study aims at using evidence-based medicine evaluation method of literature—Meta analysis to Systematically evaluate the difference of curative effect anddrug safety of traditional Chinese medicine in the treatment of POI and POF,andsummarizing the syndrome types and medication rules of the included literature,so as to provide an effective basis for clinical treatment of POI and POF,and to a certain extentstandardize the diagnosis and treatment of POI in Chinese medicine,and then earlydetection and early intervention to improve the quality of life and prognosis of patients.Method:According to the production steps of Meat analysis,the study designs a canonical and reasonable inclusion and exclusion criteria.The data about the clinical randomized controlled trials of TCM in the treatment of POI/POF published at home and abroad,which were collected from China National Knowledge Internet,Wanfang,VIP,China Biomedical Literature Database,Pub Med,Embass,Cochrane Library and Clinical Registration Center From 2011 to 2021.Imported the retrieved literature into the Note Express software and deleted repetitive literature,and the qualified literature were selected strictly according to the inclusion and exclusion criteria.After using the Cochrane Bias Risk Assessment Tool to evaluate the literature quality and extract relevant effective data,the extracted outcome data were analyzed by the Rev Man5.3 software.Results:This study conducted a meta-analysis on 13 outcome indicators with the help of 30 literature.Among them,9 of them are about POI disease type including 572 cases within 3 months treatment.The other are about POF disease type including 1,323 cases of 3months treatment or longer.（1）POIClinical comprehensive efficacy:[OR（95%CI）=2.33（1.39,3.91）,P=0.001],TCM syndrome efficacy:[OR（95%CI）=3.67（1.24,10.89）,P=0.02],TCM syndrome score:[SMD（95%CI）=-1.14（-2.12,-0.69）,P=0.0001],LH:[SMD（95%CI）=-0.47（-0.93,-0.01）,P=0.04],E₂:[SMD（95%CI）=1.12（0.14,2.10）,P=0.03],AMH:[SMD（95%CI）=1.80（0.55,3.06）,P=0.005],the above results were all P<0.05,the difference was statistically significant,in the clinical comprehensive efficacy,TCM syndrome curative efficacy/score,LH,E₂,AMH,the treatment of the observation group was better than the control group.The difference was not statistically significant in the improvement of FSH:[SMD（95%CI）=0.78（-1.60,0.05）,P=0.06],AFC:[SMD（95%CI）=0.69（-0.19,1.56）,P=0.13],and the observation group had the same efficacy as the control group.（2）POFAfter 3 months of treatment:clinical comprehensive efficacy:[OR（95%CI）=1.75（0.95,3.23）,P=0.07],menstrual efficacy:[OR（95%CI）=0.74（0.04,12.80）,P=0.84],FSH:[SMD（95%CI）=-0.39（-0.81,0.03）,P=0.07],E₂:[SMD（95%CI）=-0.38（-0.04,0.80）,P=0.08],OV:[SMD（95%CI）=-0.11（-0.40,18）,P=0.46],TCM syndrome score:[SMD（95%CI）=-0.77（-1.63,0.10）,Z=1.74,P=0.08],the above results were all P>0.05.TCM syndrome efficacy:[or（95%CI）=5.50（3.30,9.18）,P<0.00001],Kupperman score:[MD（95%CI）=-2.31（-3.36,-1.26）,P<0.0001],LH:[SMD（95%CI）=-0.54（-1.01,-0.07）,P=0.02],AMH:[SMD（95%CI）=0.88（0.54,1.23）,P<0.00001],INH-B:[SMD（95%CI）=0.47（0.08,0.86）,P=0.02],the above results were all P<0.05.A descriptive analysis on the improvement of AFC after 3 months of treatment showed that there was no statistically significant difference in the number of antral follicles between the observation group and the control group.To sum up,after 3 months of treatment,there is no statistically significant difference between TCM treatment and hormone treatment in terms of improving clinical comprehensive efficacy,menstrual efficacy,FSH,E₂,AFC,OV and TCM syndrome score,but it was better in improving TCM syndrome efficacy,Kupperman score,LH,AMH and INH-B.After 6 months of treatment:clinical comprehensive efficacy:[OR（95%CI）=1.14（0.64,2.05）,P=0.65],menstrual efficacy:[OR（95%CI）=2.31（0.78,6.83）,P=0.13],AFC:[MD（95%CI）=0.30（-0.23,0.86）,P=0.27],E₂:[SMD（95%CI）=0.38（-0.11,0.87）,P=0.13],OV:[SMD（95%CI）=0.26（-0.09,0.60）,P=0.15],TCM syndrome score:[SMD（95%CI）=-0.27（-0.89,0.35）,P=0.40],above All are P>0.05.TCM syndrome efficacy:[OR（95%CI）=2.27（1.11,4.66）,P=0.02],FSH:[SMD（95%CI）=-0.32（-0.61,-0.03）,P=0.03],LH:[SMD（95%CI）=-0.37（-0.70,-0.04）,P=0.03],all of the above are P<0.05.Two descriptive analysis results respectively showed that the improvement of AMH and INH-B after 6 months of treatment was statistically significant.In summary,after 6 months of treatment,TCM has more advantages in reducing FSH,LH,INH-B and improving the efficacy of TCM syndromes and AMH,but there was no significant difference in improving menstruation and clinical comprehensive efficacy,E2,AFC,OV and TCM syndrome score.Withdrawal for more than 3 months:TCM treatment in improving FSH:[SMD（95%CI）=-0.32（-0.61,-0.03）,P=0.03],LH:[SMD（95%CI）=-2.27（-3.47,-1.07）,P=0.0002],E₂:[SMD（95%CI）=2.66（1.39,3.94）,P<0.0001],TCM syndrome score:[SMD（95%CI）=-1.87（-2.34,-1.40）,P<0.0001]has persistent curative effect and can reduce the recurrence rate.Adverse reactions:[OR（95%CI）=0.04（0.01,0.14）,P=0.00001],the difference has statistically significant,TCM treatment has a low incidence rate.Conclusion:1.The use of TCM in the treatment of POI and POF compared with hormone therapy can improve the clinical comprehensive efficacy,the efficacy of TCM syndromes and the improvement of TCM syndrome scores,but the efficacy of TCM therapy and hormone therapy is equivalent in terms of menstrual efficacy.2.The treatment of POI and POF with TCM can improve the levels of FSH,LH,AMH,INH-B to a certain extent during the treatment period.There is no obvious advantage in improving E₂ compared with hormone therapy.However,the treatment of TCM has a long-lasting effect and can continuously improve ovarian function.After stopping the drug For 3months and above,the fluctuation level of FSH,LH and E₂ is smaller than that of hormone therapy,suggesting that the therapeutic effect of TCM is longer.However,there is no difference in the efficacy of TCM compared with hormone therapy in terms of ovarian volume changes and increasing the number of antral follicles.3.In terms of safety,TCM therapy has more advantages,and there are fewer adverse reactions than hormone therapy alone.4.The syndrome types of POI and POF are mainly kidney deficiency,often combined with stagnation of the liver,blood stasis,and liver yin deficiency.The clinical drugs often choose drugs that nourish the liver and kidney,promote blood circulation and remove blood stasis.Shu Dihuang is the most frequently administered drug in this study.Followed by Cuscuta and Angelica.