Clinical Literature Research Of Traditional Chinese Medicine Of Promoting Blood Circulation And Removing Blood Stasis For Uterine Fibroid

ObjectiveThe clinical research literature on TCM uterine fibroid in the past 20 years was collected and systematically evaluated and meta-analyzed.To evaluate the clinical efficacy of traditional Chinese medicine of the treatment of uterine fibroid,this is to find out the merits and shortcomings of traditional Chinese medicine in the treatment of uterine fibroid,thus the result can provide guidance and reference for the clinical research in the future.MethodsThe search strategy is to search and study the domestic literature researches on the treatment of uterine fibroid in Chinese medicine,then to develop exclusion and inclusion criteria via using computer search literature.As a result,the clinical research literature of Chinese medicine for uterine fibroid are being searched and analyzed.1.Meta analysis:Methodological evaluation for systematic evaluation is based on the“biased risk assessment tool”recommended by the Cochrane Collaboration Network to conduct the RCT literature quality evaluation;inclusion and exclusion criteria in RCT literature,efficacy criteria,randomization method,sample content.The literature was included in the meta-analysis,and the collected data were analyzed using the statistical software Revman 5.3 provided by the Cochrane Collaboration Network to evaluate the efficacy of TCM treatment of uterine fibroid.2.Distribution of TCM drugs on the frequency used on the treatment of uterine fibroid in the past 20 years:Statistical analysis is carried out on all included literature researches.Excel software is used to set up a database of Frequency analysis,and SPSS 26.0 statistical software is undergone the Cluster analysis.Results1.Meta analysis:Total 1,032 literature studies regarding the of uterine fibroid are searched.30 RCT literature studies of Traditional Chinese medicine(TCM)for promoting blood circulation and removing blood stasis are included for meta analysis.(1)Regarding the TCM for promoting blood circulation and removing blood stasis(including both single use of TCM formula,and TCM formula combined use with Mifepristone)against Mifepristone studies,the result shows the total effective rate,reduction of uterine volume,Estradiol,Follicle stimulating hormone level of both methods are statistically significant difference.The TCM formula are superior to western medicine(P<0.01).The adverse drug reaction in mifepristone therapy is greater than the traditional Chinese medicine for promoting blood circulation and removing blood stasis.However,the reduction of fibroid volume,progesterone(P),luteinizing hormone(LH)level are not statistically significant difference of mifepristone therapy against the traditional Chinese medicine for promoting blood circulation and removing blood stasis.The following aspects are statistically significant.The total effective rate[OR=0.23,95%,CI(0,17,0.29),P<0.00001]shows the use of TCM formula is superior to Western medicine(P<0.01).The reduction of uterine volume[OR=-58.60,95%,CI(-67.22,-49.97),P<0.00001]shows the use of TCM formula is superior to Western medicine(P<0.01).The reduction of Estradiol level[OR=-49.70,95%,CI(-52.86,-46.55),P<0.00001]shows this use of TCM formula is superior to Western medicine(P<0.01).The reduction of Follicle stimulating hormone level[OR=-2.15,95%,CI(-2.65,-1.66),P<0.00001]shows this use of TCM formula is superior to Western medicine(P<0.01).The adverse drug reaction in mifepristone therapy[OR=2.38,95%,CI(1.59,3.56),P<0.0001]shows Western medicine is greater than of the traditional Chinese medicine for promoting blood circulation and removing blood stasis(P<0.01).(2)Regarding the single use of TCM for promoting blood circulation and removing blood stasis against Mifepristone studies,the result shows the total effective rate,reduction of uterine volume,Estradiol,Follicle stimulating hormone level are statistically significant difference.The TCM formula are superior to western medicine(P<0.01).The adverse drug reaction in mifepristone therapy is greater than the traditional Chinese medicine for promoting blood circulation and removing blood stasis.However,the reduction of fibroid volume,progesterone(P),luteinizing hormone(LH)level,and the amount of menstrual flow are not statistically significant difference of mifepristone therapy against the traditional Chinese medicine for promoting blood circulation and removing blood stasis.The following aspects are statistically significant.The total effective rate[OR=0.21,95%,CI(0.16,0.28),P<0.00001]shows the use of TCM formula is superior to Western medicine(P<0.01).The reduction of uterine volume[OR=-59.04,95%,CI(-68.11,-49.98),P<0.00001]shows the use of TCM formula is superior to Western medicine(P<0.01).The reduction of Estradiol level[OR=-50.05,95%,CI(-53.26,-46.84),P<0.00001]shows this use of TCM formula is superior to Western medicine(P<0.01).The reduction of Follicle stimulating hormone level[OR=-2.15,95%,CI(-2.68,-1.61),P<0.00001]shows this use of TCM formula is superior to Western medicine(P<0.01).The adverse drug reaction in mifepristone therapy[OR=2.21,95%,CI(1.41,3.47),P<0.0006]shows Western medicine is greater than of the traditional Chinese medicine for promoting blood circulation and removing blood stasis(P<0.01).2.Frequency Analysis(1)TCM formula of promoting blood circulation and removing blood stasis.The order of occurrence of Drug type analysis in the literature from high to low is:qi medicine(21.75%),blood circulation medicine(21.28%),heat-clearing medicine(17.97%),water-wetting medicine(14.89%)and tonic medicine(14.89%).The order of occurrence of Drug analysis in the literature from high to low is:CHISHAO(8.75%),DANPI(8.51%),GUIZHI(8.27%),TAOREN(8.27%),FULING(8.27%),DANGGUI(8.94%),XIANGFU(7.57%),ZHIKE(7.09%),WUYAO(7.09%),YIYIREN(6.62%).(2)Single use of TCM formulaThe 175 traditional Chinese medicines used for treating uterine fibroid in the literature studies are categorized into 18 drug types.The order of occurrence of Drug type analysis in the literature from high to low is:blood circulation medicine(27.17%),tonic medicine(19.29%),heat-clearing medicine(16.00%),qi medicine(9.42%)and water-wetting medicine(6.40%).The order of occurrence of Drug analysis in the literature from high to low is:TAOREN(4.77%),CHISHAO(4.43%),FULING(4.28%),GUIZHI(4.12%),DANPI(4.00%),EZHU(3.94%),SANLENG(3.69%),DANGGUI(3.69%),XIANGFU(2.58%),HUANGQI(2.34%).(3)The order of occurrence of Insecticide accounts of total 2.43%in the literature from high to low is:SHUIZHI(1.05%)TUBIECHONG(0.95%),DELONG(0.22%),JIANGCAN(0.12%),WUGONG(0.06%),MENGCHONG(0.03%).Insecticide can treat the severe cases of uterine fibroid because of its strong power of removing blood statis.(4)The order of occurrence of Digestion drug accounts of total 1.48%in the literature from high to low is:JINEIJIN(0.71%),SHANZHA(0.55%),GUYA(0.15%),LAIFUZI(0.03%),SHENQU(0.03%).The uterine fibroid patient uses digestion drug to improve the digeston and prevent any hurt to spleen from drug.3.Cluster analyis C1:EZHU,SANLENG C2:WUYAO,JIXUETENG,YIYIREN,ZHIKE,XIANGFU,HONGHUA C3:CHUANSHANJIA,SHUIZHI,NIUXI,HAIZAO,KUNBU,BIEJIA,DANSHEN,XIAKUCAO,MULI,GANCAO,CHUANXIONG,BAIZHU,DANGSHEN,HUANGQI C4:DANGGUI C5:FULING,GUIZHI,DANPI,TAOREN,CHISHAOConclusionThis research study,by using Meta analysis,Frequency analysis and Cluster,is to evaluate the clinical efficacy of traditional Chinese medicine of the treatment of uterine fibroid,and the conclusion is asbelow:1.Meta analysisRegarding the TCM for promoting blood circulation and removing blood stasis(including both single use of TCM formula,and TCM formula combined use with Mifepristone)against Mifepristone studies,the result shows the total effective rate,uterine volume,Estradiol,Follicle stimulating hormone of both methods with TCM formula superior to western medicine(P<0.01).Regarding the single use of TCM for promoting blood circulation and removing blood stasis TCM formula against Mifepristone studies,the result shows the total effective rate,uterine volume,Estradiol,Follicle stimulating hormone of both methods with TCM formula are superior to western medicine mifepristone(P<0.01).The adverse drug reaction in mifepristone therapy is greater than the traditional Chinese medicine for promoting blood circulation and removing blood stasis.The reduction of fibroid volume,progesterone(P),luteinizing hormone(LH)level,and the amount of menstrual flow amount are not statistically significant in the difference of mifepristone therapy against the traditional Chinese medicine for promoting blood circulation and removing blood stasis.Based on the Meta analysis result,TCM for promoting blood circulation and removing blood stasis is superior to the Western medicine mifepristone in certain aspects,it is specifically efficacy to the type of qi stagnation and blood stasis type of uterine fibroid.Mifepristone shows an adverse drug reaction is greater than the TCM for promoting blood circulation and removing blood stasis formula.As for the increasing number of the clinical researches of the TCM for promoting blood circulation and removing blood stasis formula,this result can provide future and reference for the clinical research in the future.2.The pattern of TCM drug on treatment of uterine fibroidBased on the result of Frequency analysis and Cluster analysis,it shows that the most common drugs of treating uterine fibroid are FULING,GUIZHI,DANPI,TAOREN,CHISHAO.All the top 5 drugs are formulated the GUIZHI FULING pill.GUIZHI FULING pill is prescribed as the fundamental formula to improve blood circulation and remove blood statsis;tonify the liver,kidney and spleen;tonify the qi and zheng qi.The different forms of drug are used in different stages of the uterine fibroid treatment.Insecticide is of high drug efficacy.It is used at small dose under precise TCM diagnosis,and not recommended for long term use.Digestion drug helps improve the digestion function,and protect the spleen function and zheng qi from drug effect.Innovation:In the course of searching the literature research studies on uterine fibroids treated by Chinese medicine for the recent 20 years,it has been found that since 2013,the research on the method of Traditional Chinese medicine for promoting blood circulation and removing blood stasis has been used as the observation group.From 2013 to 2018,30 out of 40 literature research studies were included in the study.The randomized controlled trial clinical research literature was analyzed by Meta analysis,and 38 prescriptions of traditional Chinese medicine for promoting blood circulation and removing blood stasis were used as the study for the treatment of uterine fibroids.With the increase number of the randomized controlled trial clinical research literatures on the treatment of uterine fibroids in the future,it is worthwhile conducting further study on the treatment of uterine fibroids with traditional Chinese medicine or Chinese medicine combined with Western medicine.Inadequacies and Prospect:The research is limited to the use of traditional Chinese medicine prescription.There is no comprehensive literature including Chinese and Western medicine combination therapy,acupuncture treatment,acupuncture combined with traditional Chinese medicine,etc.Thus,the traditional Chinese medicine treatment of uterine fibroids will be expected further explore in-depth on the rules and regulations of the Chinese medicine used in the future.Due to limited resources and time,there is no systematic and comprehensive evaluation of the literature on uterine fibroids,which is expected to have a more indepth discussion in the future.