| ObjectivesTo evaluate the efficacy and safety of Reinforcing Kidney and Activating Blood Circulation of Chinese Herbal Medicine by comparison with western medicine (CC,HCG) for ovulation failure infertility; and to observe a116case of clinical efficacy on therepy ovulation failure infertility of Kidney-deficiency and blood stasis, in order to provide evidence for clinical study.Methods1、To Search the following databases:Cochrane Database of Systematic Reviews(DSR) and Cochrane Central Register of Controlled Trials (CCRC), PubMed, CBMWeb, Chinese National Knowledge Infrastructure (CNKI), VIP, Wanfang. In addition, all reference lists of included trials were searched and experts in the field were contacted to locate trials. Search the RCT(randomized-controlled trials) literatures about TCM (Traditional Chinese Medicine), especially Reinforcing Kidney and Activating Blood Circulation of Chinese herbal medicine, for ovulation failure infertility. According to the internalizing standard to screening strictly the study literatures. Use the standard that CochraneHandbook5.1.0recommend the RCT methodology quality evaluation to evaluate the study literatures’ quality. The results could be analyzed with Revman5.1.2、Collecting116patients of ovulation failure infertility who must be fitting the standard of the internalize case, to randomly divide two groups,there are86cases in the experiment group and30cases in the control group. From the fifth day of menstruation, give the86cases in the experiment group the Reinforcing Kidney and Activating Blood Circulation of chinese herbal medicine(tusizi,chuanduan,gouqizi,jixueteng,nvzhenzi,zelan, puhuang,xiangfu,danggui, chuanniuxi), one day a dose and twice one day. And take medicine14-days continually. From the fifth day of menstruation, give the30cases in control group CC,50or100mg every time and once one day.And take medicine5-days. Meanwhile monitor BBT, transvaginal sonography and sex hormone(FSH, LH,E2,P,T). Compare with these indexes (such as Pregnancy rate, ovulation rate,zhenghou,BBT, transvaginal sonography and sex hormone) in the experiment group and in the control group in order to observe the clinical efficacy.Results1、We have retrieved a total of708relevant documents by the English and Chinese Databases. By reading the summary, removing the literatures that donot meet the included standards and the duplicate. And also we read the fulltext to exclude the uncertainty articles. In the end, there are19literatures may meet the included standards. To evaluate the articles find that there are no multi-center study, not describe concrete methods of random allocation,blindness and concealment, not mention the number of lost and ITT analysis. There are only three literatures reporting the adverse drug reactions.The subject analyse the outcomes for enforcing Kidney and Activating Blood Circulation of chinese medicine compared with western medicine (CC,HCG)for ovulation failure infertility. There are a total of17literatures reporting the Pregnancy Rate,10ones reporting the Ovulation Rate,5ones reporting the Abortion Rate,3ones reporting the size of the ovarian follicle and endometrium and9ones reporting the total effective rate. The results show that chinese medicine is effiective, the Pregnancy Rate and the total effective rate of TCM group are significantly higher than that of western medicine group. There is no significant difference in the ovulation rate, the Abortion rate of TCM group is significantly lower than that of western medicine group. There are significant difference in the size of the ovarian follicle and endometrium.2、Reinforcing Kidney and Activating Blood Circulation of chinese herbal medicine for ovulation failure infertility:in the experiment group the total effective rate is88.37%, the pregnancy rate is58.14%, the ovulation rate is68.6%; in the control group the total effective rate is76.67%, the pregnancy rate is36.67%, the ovulation rate is70%, there is significant difference between the experiment group and control group on the pregnancy rate, and there is no significant difference between the experiment group and the control group on the ovulation rate.There are significant difference on the zhenghou between prior-treatment and post-treatment respectively in the experiment group and the control group, meanwhile there are significant difference on the zhenghou between the experiment group and the control group at post-treatment.There are significant difference for the size of the ovarian follicle and endometrium between prior-treatment and post-treatment in the experiment group and there are significant difference for the size of the ovarian follicle between prior-treatment and post-treatment in the control group. There is the modulation for FSH, LH, E2and P in the experiment,there is no significant difference for FSH, LH, E2and P in the control group.Conclusions1、TCM especially Reinforcing Kidney and Activating Blood Circulation of chinese medicine is the effective for ovulation failure infertility. However, the RCTs are of poor methodological quality and small sample size, and the results require confirmation and re-evaluation with rigorously multi-center controlled studies in the future.2、The Reinforcing Kidney, Activating Blood Circulation and Ovarian Stimulation of Chinese herbal medicine (tusizi,chuanduan,gouqiz,jixueteng,nvzhenzi,zelan,puhuang, danggui,chuanniuxi) make body balance between yin and yang, qi and blood circulation, viscera function coordination. Accordingly remove gonads axis, promote follicular development and ovulation. Research discover the Reinforcing Kidney Activating Blood Circulation and Ovarian Stimulation of Chinese Herbal Medicine could significantly improve the clinical symptoms of patients, could regulate gonadotrophic hormone, E2and P, low T and promote follicular development and endometrium growth, thus improve the ovulation Rate and the Pregnancy Rate. |
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