| ObjectivesThe spleen and stomach are the source of acquired constitution and the source of qi and blood formation.The kidneys is nourished by the spleen and stomach even if be the basis congenital constitution.Professor Deng Tietao,National Chinese Medical Science Master and well-known on spleen and stomach diseases,also emphasized the relationship between the spleen and the kidney.This article has systematically commented on,from the perspective of spleen and kidney homology,the effectiveness and safety of Jianpi Huatan Bushen Chinese herbal medicines in the treatment of polycystic ovary syndrome(PCOS)and to analyze the medication rules and characteristics of such medicines,for the purposes of providing evidence-based medicines and clinical medication references for clinical treatments.MethodsWe have conducted searches through the computer network databases of Wanfang Data,CNKI,VIP,Sinomed,Pub Med and The Cochrane Library,and adopted combined searches of subject words,free words and keywords to locate articles on treatments of PCOS by Jianpi Huatan Bushen Chinese herbal medicines.The searched period is from the establishment of the databases until 31 December 2020.By adopting the inclusion and exclusion criteria,two researchers had individually undertaken article screenings,data extractions and quality assessments.By using the Review Manager 5.4 software,the researchers had conducted the heterogeneity analysis and statistical analysis against the outcome indictors,and conducted the subgroup analysis and sensitivity analysis for heterogeneous results in order to identify possible sources of heterogeneity.We had built our database by entering information such as authors’ names,publication years and their prescriptions as shown in the articles into the TCM Inheritance Assistant System V2.5,and analyzed and concluded the rules and characteristics of the relevant drug use by using the Apriori algorithm and association rules analysis.ResultsWe have included 23 randomized controlled trials and a total of 1709 research subjects.There were 1689 cases with completed treatments,852 cases under treatments,and 837 cases in the control group.All the articles met the inclusion and exclusion criteria,among which95.65%(22/23)were scored at 3 points and 4.35%(1/23)were scored at 4 points according to the Jadad scale.We had conducted the combined effect size analaysis with 12 outcome indicators including one major outcome indicator(i.e.,clinical effectiveness),ten secondary outcome indicators(i.e.,average ovarian volume,luteinizing hormone,follicle stimulating hormone,luteinizing hormone/follicle stimulating hormone,estradiol,testosterone,insulin resistance index,fasting Insulin,body mass index,triglyceride)and the safety indicators(i.e.,the adverse reaction rates):There were ten outcome indicators had statistically significant difference in clinical effectiveness [RR=1.29,95%CI(1.23,1.36),P<0.00001],average ovarian volume [MD=-1.88,95%CI(-2.43,-1.32),P<0.00001],luteinizing hormone [SMD=-0.67,95%CI(-0.97,-0.37),P<0.0001],follicle stimulating hormone [SMD=-0.31,95%CI(-0.59,-0.03),P=0.03],LH/FSH [MD =-0.26,95%CI(-0.40,-0.11),P = 0.0005],estradiol [SMD = 0.67,95%CI(0.27,1.08),P = 0.001],testosterone [SMD =-0.55,95%CI(-0.71,-0.38),P <0.00001],insulin resistance index [MD=-0.97,95%CI(-1.59,-0.34),P=0.002],fasting Insulin [SMD =-1.05,95%CI(-1.47,-0.63),P < 0.00001],triglyceride [SMD =-1.03,95%CI(-1.55,-0.52),P <0.0001].Meanwhile there were two outcome indicators had no statistically significant difference in reducing body mass index [MD=-0.87,95%CI(-2.98,1.24),P=0.42] and the adverse reaction rates [RR=0.42,95%CI(0.16,1.08),P=0.07].When we excluded the articles with high-sensitivity via the subgroup and sensitivity analysis,we found the statistical significance of the results of the average ovarian volume,follicle stimulating hormone,and the incidence of adverse reactions had changed and were unstable,while the other outcome indicators remained stable.According to our analysis of the Chinese herbal medication rules for 23 selected Jianpi Huatan Bushen fomulas,there were 75 Chinese medicines and 290 drug frequencies.Warm is the main property of four Qi and sweet is the most one in five tastes.These 75 Chinese medicines mainly belongs to liver,spleen and kidney channels.There were 12 Chinese herbal medicines in the prescription with drug frequencies of above 40% and their frequencies(from high to low)are: Cuscuta,Poria,Angelica,Rehmannia,Salvia,Epimedium,Pinellia,Atractylodes macrocephala,Cymbidium,Atractylodes Iancea,Lycium barbarum,Tangerine peel.Based on the analysis of association rules,when we selected a support level of 10(i.e.,40%)for statistics analysis,we have obtained seven core drug pairs of Chinese medicine.They are,according to the frequency levels,(1)Cuscuta,Poria;(2)Angelica,Poria;(3)Rehmannia,Angelica;(4)Cuscuta,Angelica;(5)Rehmannia,Poria;(6)Epimedium,Poria;(7)Atractylodes macrocephala,Poria.We have obtained 16 new Chinese drug pairs and eight sets of new prescription via the "new prescription analysis".ConclusionAccording to the Meta-analysis,the treatment of Jianpi Huatan Bushen Chinese herbal medicines or a combination treatment of Jianpi Huatan Bushen Chinese herbal medicines and western medicines has significant clinical effects in the treatment of PCOS,which could effectively reduce the luteinizing hormone,luteinizing hormone/follicle stimulating hormone,testosterone,insulin resistance index,fasting insulin and triglycerides,and elevate estradiol,as compared with pure western medications.As shown in the analysis of the law of traditional Chinese herbal medicine usage,we found that the core drugs and drug pairs of Jianpi Huatan Bushen Chinese herbal medicines for the treatment of PCOS can be summarized as a combination of Erzhu Erchen decoction and Guishen Pill. |
