| Objective: To observe the effectiveness and safety of Danggui Shaoyao Powder,a well-known prescription in the Synopsis of the Golden Chamber,in treating decreased ovarian reserve due to liver depression and spleen deficiency,and to provide further scientific evidence for the treatment of decreased ovarian reserve with traditional Chinese medicine and integrated traditional Chinese and western medicine,to have better guidance for the treatment of this disease.Methods: According to the inclusion and exclusion criteria of the project design,90 patients who visited Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine from January 2019 to October 2020 were collected.The clinical trial research method of random parallel control group design was carried out sequentially,and the cases were divided into 60 cases in the treatment group(30 cases in the treatment group A,30 cases in the treatment group B)and 30 cases in the control group.Treatment group A was treated with Danggui Shaoyao Powder plus or minus combined with Climen treatment,and treatment group B was treated with Danggui Shaoyao Powder plus and minus treatment,and the control group was treated with Climen.They were treated for 3 consecutive menstrual cycles.Observe the basis of the three groups before and after treatment.Serum follicle-stimulating hormone(b FSH),basal luteinizing hormone(b LH),b FSH/b LH,basal estradiol(b E2),antiMüllerian hormone(AMH),number of antral follicles in basal state(b AFC),menstrual irregularities Adjust the(main symptom)score and the changes in the total score of TCM symptoms,and evaluate the clinical efficacy of the three groups after stopping the drug for 3 months after the end of the treatment.The data obtained was statistically analyzed by SPSS 23.0,and scientific evaluation of the clinical efficacy of Danggui Shaoyao Powder for the treatment of decreased ovarian reserve.Results: Actual number of completed cases: Treatment group A completed 28 cases and dropped out 2 cases,treatment group B completed 28 cases and dropped out 2 cases,group C completed 29 cases and dropped out 1case.(1)Comparison of the numerical changes of basic FSH、 LH、 E2、FSH/LH after treatment: intra-group comparison: The values of basic FSH,LH,E2 of the three groups were all lower than before treatment,and the difference was statistically significant(P<0.01).There was no statistically significant difference in the ratio of FSH/LH(P>0.05).Comparison between groups: The basic E2 value of treatment group A and treatment group B decreased compared with treatment group B,and the difference was statistically significant(P<0.01).The basic E2 value of treatment group A was lower than that of control group,and the difference was statistically significant(P<0.01).The basic E2 value of treatment group B decreased compared with the control group,and the difference was not statistically significant(P>0.05).The basic FSH,LH and FSH/LH ratios of treatment group A,treatment group B,and control group decreased,but there was no statistically significant difference between the groups(all P>0.05).(2)Comparison of changes in AMH values after treatment: Comparison within groups: There was no statistically significant difference in changes in AMH levels between the three groups(P>0.05).Comparison between groups:There was no significant difference in AMH levels between treatment group A,treatment group B and control group(P>0.05).(3)Comparison of changes in antral follicle counts after treatment:comparison within the group: the antral follicle counts of the three groups were all higher than before,and the difference was statistically different(P<0.01).Comparison between groups: treatment group A and treatment group B increased antral follicle count,but the difference was not statistically significant(P>0.05),treatment group A compared with the control group increased antral follicle count,the difference was statistically significant(P< 0.01),the antral follicle count of treatment group B increased compared with the control group,and the difference was statistically significant(P<0.01).(4)Comparison of changes in the scores of irregular menstruation(main symptoms)after treatment: intra-group comparison: The scores of irregular menstruation(main symptoms)in the three groups after treatment were all lower than before treatment,and the difference was statistically different(P<0.01).Comparison between groups: The scores of irregular menstruation(main symptoms)decreased in treatment group A and treatment group B,and the difference was statistically significant(P<0.01).The scores of irregular menstruation(main symptoms)decreased in treatment group A and the control group,and the difference was statistically significant(P<0.01),The scores of irregular menstruation(main symptoms)decreased in treatment group B and the control group,and the difference was statistically significant(P<0.05)(5)Comparison of changes in total TCM symptom scores after treatment:Comparison within groups: After treatment,the total TCM symptom scores of the three groups were all lower than before treatment,and the difference was statistically significant(P<0.01).Comparison between groups: The total TCM symptom scores of treatment group A and treatment group B decreased,and the difference was statistically significant(P<0.01).The total TCM symptom scores of treatment group A and the control group decreased,and the difference was statistically significant(P<0.01).The total TCM symptom scores of treatment group B and the control group decreased,and the difference was statistically significant(P<0.01).(6)Comparison of comprehensive efficacy after treatment: 3 patients in treatment group A recovered clinically,2 patients in treatment group B recovered clinically,and no patients in the control group recovered clinically.The treatment effect of treatment group A,treatment group B,and control group was significantly different(P<0.01).Comparison between groups: There is no statistically significant difference in therapeutic effect between treatment group A and treatment group B(P>0.05),compared with treatment group A and control group,the difference in therapeutic effect is statistically significant(P<0.01),compared with treatment group B and the control group,the difference in efficacy was statistically significant(P<0.01).Conclusion(s):(1)Treatment group A(Danggui Shaoyao Powder plus and minus combined with Climen)and treatment group B(Danggui Shaoyao Powder plus and minus)can effectively reduce b FSH,b LH,b E2,and increase AFC,which is believed to improve ovarian reserve.And the reduction of b E2 value and the increase of AFC were more obvious than those of the control group.(2)Both treatment group A(Danggui Shaoyao Powder plus and minus combined with Climen)and treatment group B(Danggui Shaoyao Powder plus and minus)can effectively reduce the patient’s irregular menstruation(main symptom)score and the total score of TCM symptoms,so that The symptoms of irregular menstruation,abdominal distension,good heave a deep sign,depression,and poor appetite were significantly improved,and the score reduction was significantly higher than that of the control group.(3)The therapeutic effect of treatment group A(Danggui Shaoyao Powder plus and minus combined with Climen)was better than the other two groups,indicating that the treatment effect of Danggui Shaoyao Powder plus and minus with Climen was the best.(4)Treatment group A(Danggui Shaoyao Powder plus or minus combined with Climen and treatment group B(Danggui Shaoyao Powder plus and minus)were not seen adverse reactions in the clinical research process and follow-up on the treatment of decreased ovarian reserve due to liver depression and spleen deficiency.It is believed that this method is safe and effective for the treatment of decreased ovarian reserve due to liver depression and spleen deficiency,and can be promoted and applied in clinical practice. |
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