A Clinical Study On Bushen Huoxue Culuan Ricipe In Treating Infertility Patients Suffering From Diminished Ovarian Reserve

1 BackgroundOvarian reserve function refers to the ability of follicle growth,development and formation of fertile eggs in the ovarian cortex,reflecting the female reproductive potential.Oocytes in the ovary cortex decreased in number and(or)decreased in quality,called diminished ovarian reserve(DOR).In recent years,with the development of social economy,the increase of living pressure,the aggravation of environmental pollution and the postponement of childbearing age,the number of patients with DOR infertility is on the rise.Western medicine such as hormone and promoting ovulation therapy are often used to treat infertility patients suffering from Diminished Ovarian Reserve,but it can cause the side effects of increasing the incidence of endometrial cancer,breast cancer,and ovarian stimulation.Traditional Chinese medicine has unique advantages in the treatment of this disease.It is effective in restoring ovarian function,promoting the growth and development of follicle,and increasing pregnancy,with small side effects and high safety.Many doctors in traditional Chinese medicine believed that kidney deficiency and blood stasis were the main causes and pathogenesis of this disease.They advocated that nourishing kidney and activating blood was the main treatment.This method of treatment had a significant clinical effect.2 A Systematic Review on Bushen Huoxue ricipe in Treating Patients Suffering from Diminished Ovarian Reserve2.1 ObjectveThe efficacy and safety of Bushen Huoxue ricipe in treating patients suffering from diminished ovarian reserve were evaluated systematically in order to provide evidence based evidence-based medicine for clinical treatment of Bushen Huoxue ricipe2.2 MethodsDatabases such as CNKI,WanFang,VIP,CBM,PubMed,Embase and Cochrane Library,were searched on Randomized Controlled Trial/Quasi-Randomized Controlled Trial about Bushen Huoxue ricipe in treating patients suffering from diminished ovarian reserve form the inception of the study until June 2017.The studies were screened according to inclusion and exclusion criteria.Risk of bias evaluation tools were adopted to conduct quality evaluation.Meta-analysis on outcome indicator was performed by RevMan Version 5.3 Software.Due to the different Bushen Huoxue recipe(observation group)and the different western medicine(control group)of all included studies,the effect size was combined by the random effect model after the subgroup analysis or sensitivity analysis was performed.2.3 ResultsEventually 11 trials were included,including 733 cases of patients.Results of Meta-analysis indicated that,Bushen Huoxue recipe had advantages over western medicine on lowering FSH,increasing AMH and AFC,enhancing the Chinese medicine symptom curative effect;Bushen Huoxue recipe had no advantages over western medicine on increasing E2;the advantages of Bushen Huoxue recipe were not clear on reducing FSH/LH and increasing total effective rate because of the different outcomes to compared with the different western medicine;no serious adverse reaction appering from Bushen Huoxue recipe was reported in the including researches.2.4 ConclusionBushen Huoxue recipe has the clinical curative effect and high safety suffering from diminished ovarian reserve.However,limited by the poor quantity of studies,these conclusions remain to be examined by more center,more sample and high-quality studies.3 A Clinical Study on Bushen Huoxue Culuan Ricipe in Treating Infertility Patients Suffering from Diminished Ovarian Reserve3.1 ObjectveThis study aimed to observe that the efficacy and safety on Bushen Huoxue Culuan Ricipe in treating infertility patients suffering from Diminished Ovarian Reserve.To explore its therapeutic mechanism and provide scientific basis for clinical application.3.2 MethodsThe 61 patients who met the inclusion criteria were randomly divided into the treatment group(31 cases)and the control group(30 cases).In the treatment group patients were treated with Estradiol Valerate,Progesterone and Clomiphene,the control group were given Bushen Huoxue Culuan recipe.Two groups both have three months to take the medicine.The changes on total effective rate,ovulation rate,pregnancy rate,serum hormone indicators including FSH,LH,E2,FSH/LH,AMH and ultrasonic indicator including AFC,TCM syndrome integral and safety indicators were observed before and after treatment.The patients were followed up for 3 months to observe pregnancy and abortion.3.3 Results(1)Total effective rate:total effective rate of the treatment group was 93.55%,and the control group was 83.33%.The two groups showed significant difference(P<0.05),indicating that total effective rate of the treatment group was superior to that of the control group.(2)Ovulation rate:The ovulation rate of the treatment group was 55.91%,and the control group was 76.67%.The two groups showed significant difference(P<0.05),indicating that the effect in promoting ovulation of the control group is better than the treatment group.(3)Pregnancy rate:the pregnancy rate of the treatment group was 9.68%,the control group was 16.67%.The two groups showed no significant difference(P>0.05),indicating that the two groups were equally effective in increasing pregnancy.(4)Serum hormone and ultrasonic indicators:Comparison before and after treatment:the treatment group can obviously improve the serum hormone levels and the number of sinus follicle(P<0.01);the control group can obviously reduce FSH and LH,elevate E2 and raise AMH(P<0.01,P<0.05),and there was no obvious effect in lowering FSH/LH and increase the number of sinus follicle(P>0.05).Comparison between groups after treatment:compared with the control group,the treatment group had more advantages on reducing FSH and FSH/LH,raising AMH,and increasing the number of sinus follicle;however,the two groups were equally effective on lowering LH and raising E2.(5)TCM syndrome integral:Comparison before and after treatment:the treatment group can obviously relieve the various TCM symptoms and total symptom score(P<0.01,P<0.05);the control group can obviously relieve menstruation delay,oligomenorrhea,lumbar debility,hot water night sweats,dizzy tinnitus,decreased libido,vaginal dryness,lower abdominal pain,dark blood clots and total symptom score(P<0.01,P<0.05),and there was no significant effect on prolonging menstrual period(P>0.05).Comparison between groups after treatment:compared with the control group,the treatment group had more advantages on relieving shortened menstrual period,oligomenorrhea,lumbar debility,hot water night sweats,dizzy tinnitus,decreased libido,vaginal dryness,lower abdominal pain,dark blood clots and total symptom score(P<0.01,P<0.05),and the two groups were equally effective on relieving menstruation delay.(6)Safety indicators:safety indicators of both groups were not significantly abnormal before and after treatment.(7)Follow-up situation:59 patients were followed up(30 in the treatment group and 29 in the control group).During the follow-up 5 cases(5/30)of the patients of the treatment group were pregnant,and no miscarriage occurred in the pregnant women.Only 2 cases(2/29)of the patients of the control group were pregnant.During the treatment in the control group,2 of the 5 pregnancies were aborted(1 case of biochemical abortion,1 case of 7 weeks of abortion).3.4 ConclusionBushen Huoxue Culuan recipe can obviously increase total effective rate,ovulation rate and pregnancy rate,lower FSH,LH and FSH/LH,raise the E2 and AMH,increase the sinus follicle number and relieve the TCM symptoms.In addition,it had the long-term efficacy and high safety because of no adverse reactions.Therefore,Bushen Huoxue Culuan recipe is worthy of clinical application.