| Objective:To observe the clinical efficacy of Qingxin Zishen method in treating patients with perimenopausal syndrome(PMS)of Xinshen Bujiao type,and its effects on the scores of Modified Kupperman Index(KMI),main symptoms(hot flush and insomnia),efficacy and score of TCM Syndrome,scores of Seif-Rating Anxiety Scale(SAS),scores of Self-Rating Depression Scale(SDS),scores of Pittsburgh sleep quality index(PSQI),levels of sex hormones(FSH,LH,E2)and interleukin-6(IL-6),so as to confirm the clinical efficacy of Qingxin Zishen Decoction,and provide basis for further popularizing the clinical application of Qingxin Zishen method.To detect and analyze the level of IL-6 in PMS patients before and after treatment,and explore the relationship between microinflammation and climacteric symptoms.Methods:PARTICIPANTS:Combined with the inclusion criteria and exclusion criteria,the PMS patients of Xinshen Bujiao type diagnosed and treated in outpatient clinics and wards from December 2019 to November 2020 were screened,and 66 cases were finally included.Grouping information:All patients were randomly divided into two groups(group A and group B),each with 33 cases.Among them,3 cases fell off in the group B,3 cases fell off in the group A,6 cases fell off in total,and the remaining 60 cases were clinically observed.The group A(control group)was given Kuntai capsule orally(Scheme A),and the group B(treatment group)was given Qingxin Zishen Decoction(Scheme B).TREATMEN COURSE:8 weeks.Observation index:The changes of scores of KMI,SAS,SDS PSQI.The changes of main symptoms(hot flush and insomnia),efficacy and score of TCM Syndrome.The changes of levels of FSH,LH,E2 and IL-6.And the clinical efficacy of the two groups.Statistical methods:SPSS 26.0 statistical software was used to analyze the related data,and the related symptom scores and laboratory indexes of the experimental group and the control group were compared.Result:1.Before treatment,there was no significant difference in age,course of disease,KMI score,main syndrome(hot flush and insomnia),efficacy and score of TCM Syndrome,scores of SAS,SDS and PSQI,levels of blood FSH,LH,E2 and IL-6 between the two groups,which were comparable.2.After treatment,about the following indicators:①The total clinical curative effect rate of group B is 90%,and the group A is 80%.After the Wilcoxon Matched-Pairs Signed-Ranks Test,the difference between the two groups is not statistically significant(P>0.05),indicating that Qingxin Zishen Decoction and Kuntai Capsule The overall clinical efficacy of the treatment of PMS is equivalent.②About the KMI score:KMI scores of patients in group B and group A were significantly lower than those before treatment,and there were differences between the two groups.The results showed that both treatment methods could reduce KMI score,and Qingxinzishen Decoction was better than Kuntai Capsule in reducing KMI score of PMS patients.③About the main symptoms(hot flush and insomnia):Both groups of patients’ main symptoms such as hot flush and insomnia were obviously improved.In terms of times of hot flush,the P value of comparison between groups was 0.000.In terms of insomnia degree,the P value of comparison between groups was 0.004.The above results showed that Qingxinzishen Decoction and Kuntai Capsule could relieve the symptoms of hot flush and insomnia in PMS patients,and the therapeutic effect of Qingxinzishen Decoction was more obvious.④About the effective rate of TCM syndrome:The effective rate of TCM syndrome in group B was 96.7%,and that in group A was 73.3%.There was significant difference between the two groups(P<0.001).The above results showed that the Qingxin Zishen method was obviously superior to Kuntai Capsule in treating PMS patients.⑤About the TCM syndrome integral:The scores of TCM syndrome integral of both groups were significantly reduced.There was significant difference between the two groups(P<0.001).Through the above results,it could be concluded that the treatment methods used in group B were better than those in group A in reducing the score of TCM syndrome integral and improving TCM syndromes.⑥About the scores of SAS、SDS:Compared with the scores before treatment,the scores of patients in group B were significantly different,and the same was true in group A(P<0.05).There was no significant difference between the two groups(P>0.05).It showed that Qingxinzishen Decoction and Kuntai Capsule could reduce SAS and SDS scores of PMS patients and improve anxiety and depression symptoms of PMS patients.However,there was no obvious difference between the two methods in treating the above indexes.⑦About PSQI score:Compared with the scores before treatment,the scores of patients in group B were significantly different,and the same was true in group A(P<0.05).The comparison between the two groups showed that the difference was statistically significant(P<0.001).It showed that Qingxinzishen Decoction and Kuntai Capsule could reduce PSQI score of PMS patients and improve their sleep,and the effect of Qingxinzishen Decoction was better than that of Kuntai Capsule.⑧About the sex hormone levels:The serum FSH and LH levels of patients in group B and group A were lower than those before treatment,while the E2 levels of patients in the two groups were higher than those before treatment,and the above differences were statistically significant(P<0.05).Compared with the group A,the reduction of levels of FSH and LH and the increase of E2 levels in group B were more visible and the difference was statistically significant(P<0.001).From the above results,it could be concluded that Qingxinzishen Decoction and Kuntai Capsule could improve the sex hormone level of PMS patients(could decrease FSH and LH levels and increase E2 levels),and Qingxinzishen Decoction had more obvious effect.⑨About IL-6 level:Before treatment,among 60 PMS patients in the two groups,only 8 patients(including 4 in the experimental group and 4 in the control group)had increased IL-6.After treatment,the IL-6 levels of patients in group B and group A were within the normal range,but there were no significant differences between the before-treatment and after-treatment in the group B and the group A(P>0.05).Therefore,the levels of IL-6 in PMS patients in both groups did not change significantly before and after treatment.⑩About the safety indicators:There were no significant differences in endometrial thickness of before-treatment and after-treatment in group B and group A(P>0.05).There were no abnormalities in general vital signs,results of blood routine,urine routine,stool routine,liver and kidney function,electrocardiogram,gynecological examination and breast B-ultrasound of before-treatment and after-treatment in the two groups.It showed that Qingxinzishen Decoction could not increase the endometrial thickness of PMS patients,and had less adverse reactions,which was safe and non-toxic.Conclusion:Treating PMS patients of Xinshen Bujiao type by Qingxin Zishen method can improve the total clinical curative effect,reduce SAS and SDS scores,relieve anxiety and depression,the effect is equivalent to Kuntai Capsules.This method is superior to Kuntai Capsule in reducing KMI score,improving main symptoms(hot flush and insomnia),reducing TCM syndrome score and PSQI score,downregulating FSH and LH levels in blood and increasing E2 level.It does not increase endometrial thickness of patients,and has less adverse reactions,and is safe and nontoxic.However,the Qingxin Zishen method has no obvious effect on improving the level of IL-6 in PMS patients.It is speculated that the result is related to the possible small sample size,mild to moderate illness of PMS patients,short treatment time and only one inflammatory index.To sum up,the Qingxin Zishen method is effective in treating PMS patients of Xinshen Bujiao type with hot flush and insomnia as main symptoms,which can improve the sex hormone level of patients without increasing endometrial thickness,and is safe and effective,and worthy of clinical application. |
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