A Clinical Study On Bushen Culuan Ricipe For Polycystic Ovary Syndrome Failure Infertility

1 BackgroundThe World Health Organization lists infertility as the third largest disease after cancer and cardiovascular and cerebrovascular diseases.The morbidity of infertility in China is increasing year by year.Polycystic ovary syndrome(PCOS)is the most common reproductive endocrine disease among women of childbearing period and the main cause of anovulatory infertility.It is generally believed that the morbidity of infertility is 5%-10%,and about 70%of infertility patients without ovulation.PCOS is characterized by menstrual disorders,infertility,acne,hirsutism,acanthosis nigricans psychosis,androgen excess,insulin resistance,obesity.In the long run,there are also risks of dyslipidemia,cardiovascular disease,metabolic syndrome and cancer.Such diseases seriously affect the physical,mental health and quality of life of couples,as well as family stability and social harmony.Therefore,how to treat this disease is a hotspot in current medical research.At present,the etiology of this diseases is unknown and its pathogenesis is complex,which is difficult to treat.Hormone replacement and ovulation induction are the main clinical methods in Western medicine.Advocate diet control,exercise and stopping smoking and refrain from drinking;rational use of periodic progesterone and/or low-dose short-acting oral contraceptives to regulate menstrual cycle,clomiphene or letrozole for ovulation induction therapy;insulin resistance can be corrected with insulin sensitizers such as metformin;laparoscopic ovarian electrocoagulation,laparoscopic ovarian wedge resection and other surgical treatment or application of assisted reproductive technology can be used in necessary.These treatments have side effects such as ovarian hyperstimulation syndrome,natural abortion,ectopic pregnancy etc.Traditional Chinese medicine has a multi-system,multi-link,multi-target and multi-way,which has shown unique efficacy in the prevention and treatment of this disease.It has no obvious toxic side effects and adverse reactions.Many TCM doctors believe that kidney deficiency and blood stasis are the main etiology and pathogenesis of the disease.They advocate tonifying kidney and promoting blood circulation as the main treatment method to achieve significant clinical efficacy.2 Bushen Huoxue herbal medicine in subfertile women with polycystic ovary syndrome:a Meta-analysis2.1 ObjectveMeta-analysis of randomized controlled trials(RCTs)was conducted to clarify the effect of Bushen Huoxue herbal medicine in subfertile women with polycystic ovary syndrome.2.2 MethodsDatabases including CNKI,WanFang,VIP,SinoMed,PubMed,EMbase,The Cochrane Library were searched until September 30th,2018.Two reviewers independently assessed study eligibility,extracted data,and evaluated the risk of bias for included trials.Meta-analysis used Review Manager5.3 software.2.3 ResultsSeven RCTs(n=634)were included.Results of Meta-analysis indicated that,Bushen Huoxue herbal medicine had advantages on increasing pregnancy rate,lowering LH,T and INS.Bushen Huoxue herbal medicine were not clear on increasing ovulation rate、increasing FSH.No serious adverse reaction appearing from Bushen Huoxue herbal medicine was reported in the including researches.2.4 ConclusionThe current meta-analysis showed a promising effect of Bushen Huoxue herbal medicine in subfertile women with polycystic ovary syndrome,but the quality of current evidence was low and possible publication bias.3 A Clinical Study on Bushen Culuan Ricipe for Polycystic Ovary Syndrome Failure Infertility Syndrome Failure Infertility3.1 ObjectveTo observe the efficacy and safety of Bushen Culuan Ricipe in treating infertility caused by PCOS,and to explore its mechanism of action and provide the reference for clinical medicine use.3.2 MethodsSeventy-two cases of infertility caused by polycystic ovary syndrome(PCOS)were randomly divided into treatment group(36 cases)and control group(36 cases),continuous 3 treatments.The total effective rate,ovulation rate,pregnancy rate,serum sex hormones(FSH,LH,E2,PRL,P,T,LH/FSH),B-mode ultrasonography(number of follicles 2-9 mm in diameter,ovarian volume,endometrial thickness),BBT,TCM symptom score and safety indexes were observed.Researchers followed them for 3 month.3.3 Results(1)Total effective rate:the total effective rate of the treatment group was 91.67%,and that of the control group was 86.11%,P<0.05.It shows that the total effective rate of Bushen Culuan Ricipe is better than clomiphene.(2)Ovulation rate:The ovulation rate of treatment group was 46.43%,while that of control group was 64.24%,P<0.05.Both Bushen Culuan Ricipe and Clomiphene can promote ovulation,but the ovulation rate of Bushen Ovulation Promoting Formula is lower than that of Clomiphene.(3)Pregnancy rate:The pregnancy rate in the treatment group was 38.8%,while that in the control group was 16.7%,P<0.05.It shows that Bushen Culuan Ricipe is superior to clomiphene in improving pregnancy rate.(4)Serum sex hormones:After treatment,the treatment group compared with the control group in reducing LH,T levels and LH/FSH ratio P<0.05,the difference was statistically significant,in regulating FSH,PRL,E2 and P levels P>0.05,the difference was not statistically significant.The levels of LH,T and LH/FSH in the treatment group were significantly lower than those in the control group(P<0.05).The difference was statistically significant(P>0.05)in regulating the levels of FSH,PRL,E2 and P.There was no significant difference between the two groups.The indexes of the control group before and after treatment were all P>0.05,with no significant difference.(5)B-mode ultrasonography:After treatment,the ovarian volume of the treatment group was significantly lower than that of the control group(P<0.05).There was no significant difference in regulating the number of follicles 2-9 mm in diameter and the thickness of endometrium(P>0.05).At the same time,the number of follicles 2-9 mm in diameter,ovarian volume and endometrial thickness were improved in the treatment group after treatment,P<0.05,the difference was statistically significant.The indexes of the control group before and after treatment were all P>0.05,with no significant difference.(6)BBT:The recovery rate of basal body temperature was 69.4%in the treatment group and 55.5%in the control group.There was no significant difference between the two groups(P>0.05).(7)TCM Symptom Score:After treatment,there were significant differences between the treatment group and the control group in terms of less menstrual volume,bloody purple,abdominal prickling,lumbar and knee soreness,fatigue,and dizziness and tinnitus(P<0.05).In amenorrhea,late menstruation,decreased sexual desire and long urine,there was no significant difference between the treatment group and the control group(P>0.05).The scores of each item in the treatment group before and after treatment were all P<0.05,and the difference was statistically significant.In the control group,there was no significant difference except for less menstruation,bloody purple menstruation and abdominal prickling(P>0.05).The other items in the control group were all P<0.05,and the difference was statistically significant.(8)Safety indexes:There were no abnormalities in blood routine,urine routine,stool routine,liver and kidney function and electrocardiogram before and after treatment in both groups.(9)adverse reactions:There were no adverse reactions during treatment in both groups.(10)Follow-up results:68 patients were followed up in this study,35 in the treatment group and 33 in the control group.During the follow-up period,there were 1 pregnancy and 1 abortion in the treatment group(spontaneous abortion at 8 weeks and 5 days).3.4 ConclusionBushen Culuan Ricipe can significantly improve the total effective rate,pregnancy rate,reduce serum LH and T levels and LH/FSH ratio,reduce ovarian volume.Bushen Culuan Ricipe can significantly improve the clinical symptoms and signs of infertility patients caused by PCOS.There are significant differences in the scores of some TCM symptoms.Bushen Culuan Ricipe is safe and effective in clinic.No adverse reactions were found during the treatment,and patients ’compliance is high.It is worthy of further promotion and application.