| Research PurposeThe purpose of this sysytematic review is to evaluate the last 10years clinical efficacy and safety of Chinese medicine theroy kidney-nourishing treating for PCOS.Research Methodology1.Study object and inculusion criterialThe research object is the Chinese medicine treatment for PCOS clinicial research literature published between 2008-2018 in the medical journal of Chinese medicine treatment.Inclusion criteria:(1)Type of study:Randomized controlled trial.With methods of random grouping,such as random number table,dice,flip a coin or other methods.If it is grouped by date of admission,hospital admission number,outpatient number,visiting sequence,etc,then is it not belobgs to RCT.(2)Diagnostic criteria:PCOS diagnostic which based on European Society of Human Reproduction,Embryology or American Society for Reproductive Medicine,Obstetrics and Gynecology,Theory and practice of gynaecology and obsretrics,etc.Traditional Chinese Medicine diagnostic criterias consistent with "Infertility" or "amenorrhea",etc,based on "Guiding Principles for Clinical Study of New Chinese Medicine" or "Criteria of diagnosis and therapeutic effect of syndromes in traditional Chinese medicine",etc.(3)Research object:Patients with PCOS.(4):Intervention:Used kidney-norishing theryapy of Chinese medicine herbal decoction,boil-free granule or acupuncture.In one formula at least used 3 kinds of kidney-norishing Chinese medicine.(5)Control measures:blank control,placebo treatment,conventional western medicine treatment such as Ethinylestradiol/cyproterone acetate,letrozole,clomiphene,etc.(6)Final indicator:Effictive rate,pregnancy rate;safety Index:The number and type of adverse reaction happen among treatment and follow up.2.Search strategiesThe database include:RCT in China National Knowledge Infrastructure,SinoMed,Chongqing VIP Database,Wanfang Data,PubMed,Cochrane Library.According to different database retrieval method we formulate search strategies and retrieval type to conduct comprehesive search.3.Evaluation of methodologyAccording to the theory and principle of Evidence-Based Medicine,two independent experienced reviewers read the full text and evaluated in quality,using cross-validation,if it leads to inconsistent results,they should have discuss with the third party get consistent results.The Cochrane Collaboration tool for assessing risk of bias in randomized trials are generally acknowledged in China.We selected it to evaluate the included RCT studies for risk of bias.We evaluate six items of the included RCT studies:random sequence generation,allocation concealment,blind method of participant,evaluator-blinded,incompleted outcome report,selective outcome report.For each item had assigned the low,high or unclear risk of bias for the judgement.The evaluation result presented by bar chart,risk of bias graph and text.4.Statistical analysisNoteExpress software to organized and screen the literature of chlinical studies.Establish database in Excel 2010 to organized and extracted datas for included RCT studies.RevMan 5.3 software provided by evidence-based medicine collaboration network for meta-analysis of the data entered and make statistic.Result3408 relevant literatures were searched from 5 database.Removed duplicate 1328 litratures and screened.By reading the topic and abstract eliminated animal experiments,cell ecperiment,pharmacological experiment,etc.Removed PCOS traditional review.Removed TCM non-kidney deficiency syndrome type,nursing,complications relevant literatrues.Removed non-RCT.Removed literatrues that did not match the intervention,control measure and final indicator.Removed duplicate publication.Final inculed 123 literatures.There are no multicentre study,all are single-instituational study.All literatures only mention about stochastic method but did not described how they applied allocation concealment.2 literatures mentioned about used double-blind method or single-blind method.72 literatures clearly reported drop-out rates and loss to follow-up rates.51 literatures didn’t reported and analysed drop-out rates and loss to follow-up rates.Only 95 literatures mentioned inclusion criteria and exclusion criteria.105 literatures recorded efficacy determination.6 literatures have less then 60 samples,117 literatures have 60 samples or more,all of above didn’t explain the basis of sample size estimation.Only 90 literatures applied detailed analysis or statistical description of the situation between groups.21 literatures reported drug safety evaluation,12 literatures reported no adverse reaction were found.We meta-analysis 34 RCT used kidney-norishing theryapy(herbal decoction,boil-free granule of TCM,acupuncture)to treat PCOS patients(pregnancy rate);75 RCT used kidney-norishing theryapy(herbal decoction,boil-free granule of TCM,acupuncture)to treat PCOS patient(effective rate).5 of RCT used herbal decoction of kidney-norishing theryapy compare with western medicine to treat PCOS patients(pregnancy rate),according to the requirements of meta analysis,the control group grouped by differents medicine:clomiphene group,metformin group,diane-35 group;the result of subgroup analysis is herbal decoction group pregnancy rate is higher then control groups.19 of RCT used herbal decoction of kidney-norishing theryapy combined western medicine compare with western medicine to treat PCOS patients(pregnancy rate),according to differents medicine used in controld group,it grouped by differents medicine:clomiphene group,metformin group,diane-35 group;the result of subgroup analysis are other then metformin group,herbal decoction groups pregnancy rates are higher then control groups.5 of RCT used herbal decoction of kidney-norishing theryapy combined acupuncture compare with western medicine to treat PCOS patients(pregnancy rate),the result of meta analysis is herbal decoction of kidney-norishing theryapy combined acupuncture group pregnancy rate is higher then clomiphene group.2 of RCT used boil-free granule of TCM combined western medicine compare with western medicine to treat PCOS patients(pregnancy rate),the result of meta analysis is boil-free granule of TCM combined western medicine group pregnancy rate is higher then control group.3 of RCT used herbal decoction of kidney-norishing theryapy compare with western medicine to treat PCOS patients(pregnancy rate),according to the requirements of meta analysis,the control group grouped by differents medicine:clomiphene group,metformin group,diane-35 group;the result of subgroup analysis is herbal decoction group effective rate is higher then control groups.16 of RCT used herbal decoction of kidney-norishing theryapy compare with compare with western medicine to treat PCOS patients(effective rate),the control group grouped by:clomiphene group,metformin group,diane-35 group,letrozole group;the result of subgroup analysis are other then metformin group,herbal decoction groups effective rates are higher then western medicine groups.42 of RCT used herbal decoction of kidney-norishing theryapy combined western medicine compare with western medicine to treat PCOS patients(effective rate),according to differents medicine used in controld group,it grouped by differents medicine:clomiphene group,metformin group,diane-35 group;the result of subgroup analysis is herbal decoction group effective rate is higher then control groups.4 of RCT used boil-free granule of TCM compare with western medicine to treat PCOS patients(effective rate),the result is TCM group is higher then western medicine group.3 of RCT used acupuncture compare with western medicine to treat PCOS patients(effective rate),the result is acupuncture group is higher then western medicine group.8 of RCT used herbal decoction of kidney-norishing theryapy combined acupuncture compare with western medicine to treat PCOS patients(effective rate),the control group grouped by:clomiphene group,diane-35 group,the result are TCM+acupuncture group rate is higher then clomiphene group,but compare with diane-35 group had no statistical significance.2 of RCT used herbal decoction of kidney-norishing theryapy combined acupuncture and diane-35 compare with diane-35 only to treat PCOS patients(effective rate),the result is the combined use of TCM+acupuncture and diane-35 group effective rate is higher the the diane-35 group.Funnel plot asymmetry mean the probability of publication bias exists.ConclusionThis systematic review and meta analysis result showed that kidney-norishing theryapy(herbal decoction,boil-free granule of TCM,acupuncture)is a effective methods to treat PCOS.Kidney-norishing theryapy(herbal decoction,boil-free granule of TCM,acupuncture)can improve pregnancy rate.Top 10 highest frequency use of TCM are cuscuta,angelica sinensis,epimedium,rehmannia glutinosa,cyperus rotundus,salvia miltiorrhiza,poria,lyceum chinense,atractylodes iancea,atractylodes macrocephala.Out of 10 there are 3 kinds of kidney-norishing TCM,which tonifying yang of kidney more then yi of kidney.Out of 10 there are 2 kinds of invigorationg spleen for diuresis,2 kinds of replenishing TCM,1 kind of regulating qi-flowing TCM,1 kind of promoting blood circulation TCM,1 kind of removing dampness TCM.Other then the importance of kidney-norishing TCM,the rest TCM method are very important too.Top 10 hightest frequency use of acupuncture points are guanyuan,sanyinjiao,zigong,zhongji,zusanli,qihai,shenshu,xuehai,fenglong,guilai.6 of them are kidney-norishing acupuncture point.Base on those evedance can prove kidney nourishing of Chinese medicine is very importact to treat PCOS.Due to the poor methodological quality of RCT and publication bias exists,the clinical efficacy and safety rely in the future multicentre study to proven and reappraisal. |
PDF Full Text Request