Clinical Research On The Treatment Of Menopausal Syndrome(Liver And Kidney Yin Deficiency Syndrome) With The Wang’s Gengnian Decoction

Objective:To observe the Wang’s Gengnian Decoction combined with Tibolone Tablets for the treatment of menopausal syndrome（liver and kidney Yin deficiency syndrome）clinical efficacy,stability and safety,and to provide a new effective therapeutic options for the combination of traditional Chinese and western medicine,so as to better serve the patients.Methods:Sixty-two patients diagnosed as menopausal syndrome（liver and kidney Yin deficiency syndrome）in Jinzhong Hospital of Traditional Chinese Medicine Affiliated to Shanxi University of Chinese Medicine were selected and randomly divided into control group and treatment group,with 31 patients in each group.The control group received conventional treatment with western medicine Tibolone Tablets,and the treatment group was combined with Wang’s Gengnian Decoction on the basis of the control group.The equilibrium of age,illness and course of disease in each group was ensured during grouping.The treatment time is 12 weeks,3 months follow-up after the drug was stopped.The improvement of disease degree,clinical efficacy,TCM syndrome scores,improved Kupperman scores,sex hormone level（E₂,FSH）and other indexes in 2 groups were observed before treatment,12 weeks after treatment and 3 months after withdrawal.Results:1.Comparison of the illness degree:6,20 and 4 patients in the two groups were mild and severe respectively before treatment;12 weeks after treatment,the treatment group in the light weight each 30,0,0 cases,the control group in light weight each have 27,3,0cases;12 weeks after experiment,there were 30,0,0 cases of light and medium weight in the group using the Wang’s Gengnian Decoction combined with Tibolone Tablets and 27,3,0 cases of light and medium weight in the group using the Tibolone tablets alone.Three months after withdrawal,the use of the Wang’s Gengnian Decoction combined with Tibolone Tablets light of heavy with 30,0,0 cases,use the Tibolone tablets alone light of heavy with 28,2,0.Upon examination,P<0.05,on the statistical comparison,the difference is meaningful.2.Comparison of comprehensive clinical efficacy:The effective rate of the treatment group was 96.67%,and simply using the Tibolone tablets group was 86.67%,calculated by the improved Kupperman total scores,with statistically significant difference（P=0.001<0.05）.Integrated clinical curative effect of the Wang’s Gengnian Decoction combined with Tibolone Tablets was better than the Tibolone tablets alone.3.Comparison of the efficacy of TCM syndromes:According to the integral of TCM syndromes,the effective rate of the Wang’s Gengnian Decoction combined with Tibolone Tablets was 93.33%,and that of the Tibolone tablets alone was 83.33%.The chi-square test was used,P=0.008<0.05,the curative effect of TCM syndromes in the Wang’s Gengnian Decoction combined with Tibolone Tablets was better than the Tibolone tablets alone.4.Comparison of total scores of TCM syndromes:compared with before experiment:the total scores of TCM syndromes in both groups decreased after 12 weeks of experiment and 3 months after withdrawal,and the Wang’s Gengnian Decoction combined with Tibolone Tablets group integral fall more outstanding,there was statistical significance（P<0.05）;In the same period,there was statistical difference between the two data groups（P<0.05）.5.Comparison of the total scores of modified Kupperman:The total Kupperman scores of two groups after 12 weeks of treatment and 3 months after withdrawal were lower than before treatment,with statistical significance（P<0.01）.3 months after drug withdrawal,the total scores of the two groups were increased compared with that after 12weeks of treatment,but not more than that before treatment,with statistically significant differences（P<0.01）,and there were differences between groups in the same period（P<0.05）.6.Comparison of modified kupperman single points for main symptoms:The two groups of patients were compared between the two groups.For the symptoms of paroxysmal sweat out,night sweats and poor sleep,the treatment group was significantly different from the control group after 12 weeks of treatment and 3 months after stopping the drug.There was markedly statistical comparison（P<0.01）;for paresthesias and urinary infections,there was no markedly significant difference between two sets of data after 12weeks of experiment（P>0.05）,and the scores of the control group rebounded after 3months of discontinuation.There was no significant difference in the Wang’s Gengnian Decoction combined with Tibolone Tablets group,and the comparison between two sets of datas was statistically difference（P<0.05）;for emotional disturbance,the datas of the two groups were not statistically significant after 12 weeks of treatment and 3 months after drug withdrawal（P>0.05）.The datas of the two groups were compared within the group.For hot flashes,sweating,paresthesia,insomnia,mood swings and urinary tract inflammation,after 12 weeks of treatment and 3 months after drug withdrawal,there was statistically difference（P<0.05）;compared with 12 weeks after treatment,the control group had no statistical significance in paresthesias,mood swings and urinary infections（P>0.05）.7.Comparison of TCM main symptom scores:Comparison of the two groups of datas in the same period showed that the scores of TCM main symptoms after 12 weeks of treatment and 3 months after withdrawal were statistically significant（P<0.05）and the scores of each single item in the treatment group were lower than those in the control group,indicating that the efficacy and stability of the treatment group in the same period were better than those in the control group.Compared within the single symptom group,the scores of the Tibolone tablets alone group and the Wang’s Gengnian Decoction combined with Tibolone Tablets group after 12 weeks of treatment and 3 months after drug withdrawal were lower than those before experiment,and the scores of the Wang’s Gengnian Decoction combined with Tibolone Tablets group were more remarkable,with statistical imparities compared with those before experiment（P<0.05）.In both groups,the scores of vertigo and tinnitus symptoms decreased after 12 weeks of experiment,more significantly in the Wang’s Gengnian Decoction combined with Tibolone Tablets group,while the scores of the control group increased significantly 3 months after drug withdrawal compared with 12 weeks after treatment,and there was no difference statistically（P<0.05）.The scores of the experiment group did not increase significantly compared with 12 weeks after experiment,and there was no difference statistically.The data of the two groups were in the symptoms of sleepless sleep and more dreams,respectively.After 12 weeks of treatment and 3 months after drug withdrawal,reduced integral before the experiment,compared with before experiment were statistically significant（P<0.05）,there was no difference statistically after 12 weeks of treatment and before treatment in Tibolone Tablets group.The scores 3 months after drug withdrawal were higher than that after 12 weeks of treatment,the difference was statistically meaningful（P<0.05）.8.Comparison of sex hormone E₂and FSH levels:Compared with the same group,serum E2 levels in two groups were increased after 12 weeks of treatment,respectively,and the difference was statistically significant（P<0.05）,but the increase was more obvious in the treatment group.The level of E2 at 3 months after drug withdrawal in both groups was lower than that after 12 weeks of treatment,but still higher than that before treatment,with statistical significance（P<0.05）.There were statistical differences between the two groups in the same period（P<0.05）.Two groups of patients with serum FSH level in 12weeks after treatment,respectively,compared with before treatment were lower,and the Wang’s Gengnian Decoction combined with Tibolone Tablets group cut more apparent after experiment,there was statistical meaning（P<0.05）;FSH level in both groups increased 3 months after drug withdrawal compared with that after 12 weeks of treatment,but was still lower than that before experiment,there was a statistical meaning（P<0.05）.There was no statistical difference the data of the two groups in the same period.9.Safety observation:The two groups of patients had no obvious abnormalities in blood routine,hepatic and renal function,blood glucose,blood fat,gynecological color Doppler ultrasound and color ultrasound of breast before treatment,12 weeks after treatment and 3 months after drug withdrawal.Conclusion:Wang’s Gengnian Decoction combined with Tibolone tablets is superior to the Western medicine Tibolone tablets in the treatment of menopausal syndrome（liver and kidney Yin deficiency syndrome）patients in terms of clinical efficacy and improvement of the condition.Long-term efficacy is superior to improving its primary symptom of TCM for drug than Tibolone tablets and it can effectively regulate the level of sex hormones.It is safe and reliable without side effect and is worthy of clinical application.