| Background and Objective:With the progress of modern society,more and more women are affected by the pressure from family,work,society and other aspects.They enter menopause earlier or are more vulnerable to the menopausal syndrome related symptoms.Insomnia is a major aspect of menopausal syndrome,and its incidence rate has been on the rise in recent years.The main clinical manifestations of insomnia are difficulty in falling asleep,easy to wake up,dreaminess and difficulty in returning to sleep after waking up.For a long time,it is easy to cause disorders of human nervous system,endocrine system and immune system,which seriously affect the life quality of menopausal women.Modern medicine believes that the pathogenesis of this disease is complex and not completely clear,which is closely related to the decrease of estrogen level in women.Hormone replacement therapy and sedative hypnotic drugs are mainly used in the treatment,which has certain curative effect,but long-term use increases the risk of thrombosis and tumor in patients,and is easy to produce drug side effects,drug resistance and other problems.Under the guidance of the overall concept,traditional Chinese medicine shows unique advantages in treating the disease based on syndrome differentiation.It has the characteristics of diverse treatment methods,small side effects,and easy to be accepted by patients,so its clinical effect is significant.Professor Xiao Chengzong,a famous expert of traditional Chinese medicine in China and a famous doctor of national medicine in the capital,summed up many years of clinical experience.She believed that the main cause of the disease was kidney,liver and heart.The main pathogenesis was heart kidney disharmony and yin deficiency of liver and kidney,and she made "Gengxin Decoction" to coordinate the heart and kidney,nourishing the kidney and liver,calming the heart and tranquilizing the mind.My tutor,Professor Tang Ling,the apprentice of Professor Xiao Chengzong,was deeply influenced by the academic thoughts of Xiao's Department of gynaecology in Yanjing.In clinical practice,she applied Gengxin Decoction to treat female menopausal insomnia and achieved satisfactory results.Therefore,the purpose of this study is to evaluate the efficacy and safety of Gengxin Decoction in the treatment of female menopausal insomnia,and to provide the basis for further research on new drugs of Gengxin decoction.Research method:This study adopts a randomized controlled study method.In this study,40 cases of female climacteric insomnia patients who visited the gynecology clinic of Dongzhimen Hospital of Beijing University of traditional Chinese medicine from June 2019 to January 2021 were collected.Among them,20 cases in the experimental group were treated with Gengxin Decoction and 20 cases in the control group were treated with western medicine zopiclone.The treatment course of the two groups was 4 weeks.The general information and basic clinical information of the patients were collected,and the efficacy and safety indexes were evaluated before and after treatment.The main observations were as follows:(1)Main outcome measures:changes of PSQI score.Secondary outcome measures:changes in scores of modified Kupperman scale and TCM Syndrome Scale?changes of sleep latency and sleep time in sleep monitoring items.(2)Safety index:blood routine,urine routine,biochemical(liver and kidney function)index changes and adverse reactions during treatment.Finally,spss20.0 software was used to analyze the results.Results:1.Baseline comparison:there was no significant difference before treatment in age,course of disease,PSQI scale,modified Kupperman scale,TCM Syndrome Scale score,sleep latency and sleep time in sleep monitoring between the two groups(P>0.05).2.Clinical efficacy evaluation(1)Comparison of PSQI scores between the two groupsBefore and after treatment,the scores of the two groups were improved,the difference was statistically significant(P<0.05);after treatment,the difference between the two groups was not statistically significant(P>0.05),indicating that there was no significant difference in the improvement of PSQI score between the experimental group and the control group.(2)Comparison of modified Kupperman scale between two groupsBefore and after treatment,the scores of the two groups were improved,the difference was statistically significant(P<0.05);after treatment,the difference between the two groups was statistically significant(P<0.05),indicating that the improvement of the improved Kupperman scale score of the experimental group was better than that of the control group.(3)Comparison of TCM Syndrome Scale scores between two groupsComparison of each score:the scores of insomnia were improved in the two groups before and after treatment,and the difference was statistically significant(P<0.05).Before and after treatment,there was no significant improvement in the score of irregular menstruation in the two groups,and the difference was not statistically significant(P>0.05).In addition,the experimental group in the hot flashes and sweating,palpitation and dreaminess,five heart fever,vertigo tinnitus,waist and knee soreness,dry throat less body fluid symptom score also improved,the difference was statistically significant(P<0.05).Compared the two groups,the experimental group was better than the control group in insomnia,hot flashes and sweating,five heart trouble,dizziness and tinnitus,waist and knee soreness,the difference was statistically significant(P<0.05).Total score comparison:the total score of the two groups were improved,the difference was statistically significant(P<0.05);the difference between the two groups was statistically significant(P<0.05),the improvement of TCM Syndrome Scale score of the experimental group was better than that of the control group.(4)Comparison of sleep monitoring between the two groupsThe sleep latency and sleep time of the two groups before and after treatment were compared,and the differences were statistically significant(P<0.05).The sleep latency of the two groups were shortened,and the sleep time was prolonged.There was no significant difference between the two groups(P>0.05),indicating that there was no significant difference in shortening sleep latency and prolonging sleep time between the two groups.(5)Comparison of curative effect between two groupsMain efficacy criteria:according to the criteria of insomnia,the effective rate of the experimental group was 100%,and that of the control group was 94.1%.There was no significant difference in the effective rate of the two groups in the treatment of menopausal women with insomnia(P>0.05)Secondary efficacy criteria:according to the criteria of TCM syndrome efficacy,the effective rate of the experimental group was 80%,and that of the control group was 5.88%,the difference was statistically significant(P<0.05),the effect of the experimental group was better than that of the control group in improving other TCM syndromes except insomnia.(6)Comparison of follow-up between the two groupsThe PSQI scale score,modified Kupperman scale score and TCM syndrome score of the two groups before treatment and follow up were compared,and the differences were statistically significant(P<0.05).There was no significant difference in PSQI score between the two groups(P>0.05),but there was difference in improved Kupperman scale and TCM syndrome score between the two groups(P<0.05),and the experimental group was better than the control group.3.Safety evaluationThere were no adverse reactions in the whole process of the experiment;there were no obvious abnormalities in vital signs,blood routine,urine routine and biochemical(liver and kidney function)safety indexes before and after treatment.Research conclusion:1.Gengxin decoction has a significant clinical effect in the treatment of female menopausal insomnia(heart kidney disharmony type),which can effectively improve the symptoms of insomnia,shorten the sleep latency,prolong the sleep time,improve the sleep quality,and relieve other menopausal syndrome related symptoms such as hot flashes and sweating,palpitations and dreaminess,five heart trouble heat,dizziness and tinnitus,waist and knee soreness,dry throat and less body fluid.2.Gengxin decoction is safe in the treatment of female menopausal insomnia(heart kidney disharmony type),without adverse reactions,which is worthy of further promotion in clinic. |
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