Female Menopausal Syndrome Traditional Chinese Medicine Therapeutic Regimen Research

1 Research purposeThe topic is to study traditional Chinese medicine' s effectivity and safety in treating female menopausal syndrome;to observe and compare the Chinese patent medicine which is based on differentiation of symptoms and signs,Chinese patent medicine plus mental therapy and hormone replacement therapy,in order to tell their clinical therapeutic effects to the female climacteric syndrome and the influence to the patients' living quality;also to analyze both drugs' adverse reaction incidence rate;to make a approach to traditional Chinese medicine optimized therapy to treat female menopausal syndrome2 Research method and contentThe research topic is according to the clinical randomized controlled trial.We divide the 90 examples with menopausal syndrome into three groups at random.Each group has 30 examples.We give Chinese patent medicine to Chinese herbs group based on differentiation of symptoms and signs.We add mental therapy to Chinese herbs plus mental therapy group.We give the hormone replacement therapy to western medicine group.The three groups' treatment course is 12 weeks.We observe the TCM syndrome therapeutic effect,KI measuring scale therapeutic effect,living quality measuring scale four dimensions' changes,blood serum hormone level changes,pharmacal adverse reaction among prior treatment,post-treatment after 12 weeks and the follow-up from the 12^thweek and the 24^thweek.3 research results3.1 TCM syndrome therapeutic effect evaluation between prior treatment and post-treatment3.1.1 Three groups TCM syndrome synthetic therapeutic effect results comparison After 12 weeks' treatment,the effective percentage of Chinese herbs group,Chinese herbs plus mental therapy group,western medicine group are 80.0%,92.0%,80.8%.After 24 weeks they are70.0%,84.0%,65.4%.According to effective percentage comparison among the three groups in the 12^thweek and 24^thweek,difference has no statistical significance(P＞0.05).It indicates that the three groups have the equivalent therapeutic effect to improve TCM syndrome and have a better clinical therapeutic effect in the near future and long-term.3.1.2 The three groups' improving degree of each TCM syndrome comparisonAfter the 12^thweek treatment,to improve dark complexion,dizziness and vertigo,sore waist,difference among three groups has statistical significance(P＜0.05,P＜0.01).Specific difference as follows:dark complexion:both Chinese herbs group and Chinese herbs plus mental therapy group surpasswestern medicine group(P＜0.05),dizziness and vertigo:Chinese herbs plus mental therapy group surpass Chinese herbs group(P＜0.01),waist soreness:both Chinese herbs plus mental therapy group and western medicine group surpass Chinese herbs group(P＜0.01).3.2 Therapeutic effect evaluation in KI measuring scale between prior treatment and post-treatment3.2.1 KI measuring scale group comparison in every periodPreliminary diagnosis—within 4 weeks:both Chinese herbs group and Chinese herbs plus mental therapy group surpass western medicine group(P＜0.05), preliminary diagnosis—within 8 weeks:Chinese herbs plus mental therapy group surpass western medicine group(P＜0.05),Chinese herbs group surpass western medicine group(P＜0.05);preliminary diagnosis—within 12 weeks:Chinese herbs plus mental therapy group surpass western medicine group(P＜0.01)and western medicine group(P＜0.05).3.2.2 Each improving degree of TCM syndrome comparison in KI measuring scale between prior treatment and post-treatmentHectic fever and sweating:both Chinese herbs group and Chinese herbs plus mental therapy group surpass the western medicine group(P＜0.01); paraesthesia:both Chinese herbs group and Chinese herbs plus mental therapy group surpass the western medicine group(P＜0.05),arthralgia and courbature: western medicine group surpass Chinese herbs group(P＜0.05),cardiopalmus: Chinese herbs plus mental therapy group surpass the Chinese herbs group and the western medicine group(P＜0.05,P＜0.01),algopareunia and urinary system syndromes:western medicine group surpass Chinese herbs group and Chinese herbs plus mental therapy group(P＜0.05)3.3 Living quality evaluation between prior treatment and post-treatmentvasomotion's dimension:except that there is no significant difference between western group 24 weeks score and baseline total score,the other stages scores are significantly lower than the baseline total score in the same group (P＜0.05,P＜0.01).To compare the 12^thweek and 24^thweek to the corresponding period baseline reduce score difference mean,Chinese herbs plus mental therapy group significantly surpass the Chinese herbs group and the western medicine group(P＜0.05).It indicates that all the three groups have a better therapeutic effect in the near future to improve the vasomotion' s dimension, however,the effect in the long-term of western medicine is not so obviously, the effect in thenear future and long term of Chinese herbs plus mental therapy group significantly surpass the corresponding period Chinese herbs group and western medicine.psychological dimension:except that there is no significant difference between each treatment stage in Chineseherbs group treatment and the baseline total scores,each stage score of the other two groups are significantly lower than the baseline total score in the same group(P＜0.05,P＜0.01).To compare the corresponding period baseline reduce score difference mean in the 12^thweek, Chinese herbs plus mental therapy group significantly surpass the Chinese herbs group and the western medicine group(P＜0.01,P＜0.05).To compare the corresponding period baseline reduce score difference mean in the 24^thweek, Chinese herbs plus mental therapy group significantly surpass the Chinese herbs group(P＜0.05).It indicates that Chinese herbs plus mental therapy group and western medicine group has a better therapeutic effect in improving psychological dimension,but the therapeutic effect of Chinese herbs group is not so obviously.Also the effect in the near future of Chinese herbs plus mental therapy group significantly surpass Chinese herbs group and western medicine,the effect in the long term also significantlysurpass Chinese herbs group.Physiological dimension:except that there is no significant difference between each treatment stage in Chinese herbs group and the baseline total score,each treatment stage score of the other two groups are significantly lower than the baseline total score in the same group(P＜0.05,P＜0.01).To compare the three groups in 12^thweek and 24^thweek to the corresponding period baseline reduce score difference mean,difference has no significant meaning (P＞0.05)It indicates Chinese herbs plus mental therapy group and western medicine group has a better therapeutic effect in improving Physiological dimension,but the therapeutic effect of Chinese herbs group is not so obviously.sexual life dimension:each treatment stage scores of western medicine group are significantly lower than the baseline total score in the same group (P＜0.05).The comparison between each treatment stage of the other two groups and the baseline total score has no significant difference(P＞0.05).ro compare the western medicine group in 12^thweek and 24^thweek to the corresponding period baseline reduce score difference mean,difference has significant meaning(P＜0.05).It indicates the sexual life dimension improving effect of western medicine group is more obviously,but the sexual life dimension improving effect of Chinese herbs group and Chinese herbs plus mental therapy group are not so obviously.The research indicates the combination of Chinese patent medicine which is based on differentiation of symptoms and signs and TCM mental therapy has a significant therapeutic effect in improving the living quality of patients with menopausal syndrome,also it'effect surpass the merely Chinese herbs group and western medicine group.3.4 Comparison of hormone level between prior treatment and post-treatmentFSH is lower than the baseline level after 12 weeks' western medicine group treatment.E2 is higher than the baseline level.The difference has statistical significance(P＜0.05);the other two groups' E2,FSH level have no obviously differences with baseline between prior treatment and post-treatment.It indicates western medicine group has a better effect in improving the hormone level.It' s clinical therapeutic effect surpass the Chinese herbs group and Chinese herbs plus mental therapy group.3.5 safety evaluation and adverse reactionThe three groups have rechecked blood routine test,urine routine test, electrocardiogram,hepatorenal function and haven' t found any abnormal changes.In the research process western medicine group and western medicine group has 3 example with vagina irregular bleeding,2 example with lightly mammary gland accrementition,2 example with lightly endometrium thickening. Chinese herbs group and Chinese herbs plus mental therapy group haven' t found any adverse reaction.4 Conclusion4.1 The therapeutic effect of TCM to female menopausal syndrome can nearly equal that of western medicine.The finding indicates that the total therapeutic effect of three groups to female menopausal syndrome equal the same.To improve the patients' living quality,matching Chinese medicine with mental therapy,the long-term effect of vasomotion' s dimension and psychological dimension is more consolidated, however,the effect of hormone replacement therapy in improving the patients' sexual life dimension is more obvious.4.2 To improve some symptoms of menopausal syndrome,chinese medicine and western medicine has its own advantage.dark complexion,hectic fever,sweating,paresthesia:Chinese herbs plus mental therapy group and Chinese herbs group surpass western medicine groupdizziness and vertigo:Chinese herbs plus mental therapy group surpass Chinese herbs group.sore waist:Chinese herbs plus mental therapy group and western medicine group surpass Chinese herbs group.Cardiopalmus:Chinese herbs plus mental therapy group surpass Chinese herbs group and western medicine group.arthralgia and courbature:western medicine group surpass Chinese herbs groupalgopareunia and urinary system syndromes:western medicine group surpass Chinese herbs group and Chinese herbs plus mental therapy group4.3 Traditional chinese medicine and mental therapy is safe and reliable to female menopausal syndrome and without no obvious adverse reaction...