A Randomized Controlled Study:Treatment Of Decreased Ovarian Reserve Function In Kidney Deficiency And Blood Stasis With Acupuncture And Drug Combination

PurposeIn this study,Yishen-Zhuozang formula combined with acupuncture was used to treat patients with decreased ovarian reserve function of kidney deficiency and blood stasis type.The clinical efficacy and safety of the treatment method was evaluated by comparing the TCM syndrome scores,serum sex hormone levels,changes in the number of follicles in sinus under ultrasound,and menstrual recovery before and after treatment.MethodA total of 64 patients with decreased ovarian reserve function who met the inclusion criteria were selected from gynecology Department of Nanping People’s Hospital from February 2022 to November 2022,and randomly divided into observation group and control group,32 patients.The observation group was treated with Yishen-Zhuchao formula combined with acupuncture,while the control group was treated with acupuncture only,with a course of 3 months.The changes of TCM syndrome scores,serum sex hormone levels（FSH,LH,E₂,FSH/LH,AMH）and AFC before and after treatment were observed and compared between the two groups.SPSS23.0 statistical software was used for statistical analysis.Result1.A total of 64 patients were included in this study,and 60 clinical observers were completed.During the study,1 patient in the control group required to terminate treatment because he could not tolerate acupuncture during the acupuncture process,and 1 patient could not continue treatment because he went to school abroad,which were all excluded.In the observation group,1 case resisted taking traditional Chinese medicine during the treatment,and 1 case could not adhere to the treatment due to busy work.After 1 cycle of treatment,60cases were eliminated,and the total shedding rate was 6.25%.2.Comparison of general data:Before treatment,there was no statistical significance in age,reproductive history,abortion history,serum sex hormones,AFC and TCM syndrome scores between the two groups,indicating comparability.3.TCM syndrome scores:The total TCM syndrome scores of both groups were significantly lower after treatment than before treatment,and the observation group was better than the control group,the difference was statistically significant.4.Pregnancy status of the two groups:During the treatment,there were 2 pregnancies and 28 pregnancies in the observation group,with a pregnancy rate of about 6.67%;and there were 1 pregnancies and 29 pregnancies in the control group,with a pregnancy rate of 3.33%.5.Comparison of serum hormone levels:both groups could improve the levels of serum AMH,FSH,E₂and LH,and the observation group was significantly better than the control group in improving AMH,FSH and FSH/LH,but there was no significant difference between the two groups in improving the levels of LH and E₂.6.Comparison of AFC:After treatment,the number of AFC was increased in both groups（P<0.05）,but there was no significant difference between groups.7.Correlation between TCM syndrome score and various indicators:TCM syndrome score was correlated with age,AMH,AFC,FSH and FSH/LH,but not with LH,E₂.8.Safety analysis:There were no serious adverse reactions during treatment in both groups,and no obvious abnormalities were observed in related safety examination indexes after treatment.Conclusion1.Yishen-zhuocao recipe combined with acupuncture has significant curative effect on patients with decreased ovarian reserve function of kidney deficiency and blood stasis type,and has more advantages than the control group in reducing TCM syndrome scores.It can shorten menstrual cycle,improve menstrual volume and color,relieve the symptoms of waist and knee soreness and irritability,increase AMH level and increase the number of AFC.Lower the FSH and FSH/LH levels.2.TCM syndrome score was correlated with age,AMH,AFC,FSH and FSH/LH,but not with LH and E₂.3.There was no obvious adverse reaction during the treatment of Yishenzhuchaofang combined with acupuncture,and the safety was good.