A Clinical Randomized Controlled Trials On The Treatment Of Menopause Depression With Shugan Capsule

Background:Menopause depression affects the physiology and mental health of women severely.Nowadays,as the development of social economy,life rhythm getting faster and faster,and work pressure getting bigger and bigger,the incidence of depression,the disability rate and the suicide rate are in the trend of increasing year by year.It seriously affects the physical and mental health of menopausal women and breaks family harmony.With the coming of an aging society,people' sknowledge of depression is gradually strengthened.Current medicine mainly prescribes some antidepressant to cure the disease,if necessary assist with hormone replacement therapy or supplementary therapy. Though there are some curative effect,patients have to take medicine for a long period,and it costs a lot.The side effect is big.Patients' compliance is not so good,so patient can not totally recover from depression. Psychotherapy is also commonly used,but the effects are not steady because of the individuality,so it can not be used popularly.Depression belongs to melancholia of Chinese medicine.Chinese medicine use the method of syndrome differentiation.It takes advantage of Chinese medicine.It is better than the western medicine in the aspects of decreasing side-effects and expense. And the effect is steady.It' s not easy to rebound and It' s not addictive. It' s easy for patient to take.This study is to prove the exact effects and safety of the capsule of shugan on curing depression.Research purpose:Compare the method of taking capsule of shugan to the depressant Deanxit, and observe the clinical efficacy and safety of shugan capsule curing menopause depression.To make it easy to be used popularly.In this study,I will demonstrate the mechanism of shugan capsule and Deanxit on curing depression. Observing the results of the scale of PSQI reflects the feasibility of curing depression.Methods:This study used clinical randomized controlled trial.We chose 53 women who has menopause depression in Guangdong provincial hospital of Chinese medicine,and they all meets with the including criteria.We separate the patients into two groups in the way of simple random method.One of the group is treatment group which takes the capsule of shugan for 8 weeks.The other is the control group which takes Deanxit for 8 weeks.We let patients do the Hamilton depression scale and Pittsburgh sleep quality scale before the therapy and after 4 weeks,after 8 weeks.We detect the degree of serum 5-HT,FSH and E2.At the same time,we do some save examination,such as the blood routine, urine routine,hepatic and renal routine,electrocardiogram,et al.We make an observation table,and record the adverse effects.Results:1.Comparison of the clinical effects of the two groups:The effective rate of the treatment group is 81.5%by calculating the result of Hamilton depression scale pre and post treatment.The effective rate of the control group is 73.1%.The recovery,significantly improvement and improvement are considered effective.Compare with each other,there was no significant difference between them(P>0.05).That is to say,the effects of the two treatments are nearly the same.They both can alleviate the symptoms of depression.2.Comparison of the results of two groups with Hamilton depression scale:Compare the results of Hamilton depression scale pre and after 8 weeks treatment:compare in the groups,there was significantly difference(P<0.01). But compare in two groups,there was no significant difference.That is to say,both of the results of Hamilton depression scale are reducing,but there was no remarkable difference in the decrease range.3.Compare the result of taking medicine for 4 weeks to the result of taking medicine for 8 weeks,there are significant differences in the groups.But compare to the other group,there are no significant difference(P>0.05).That is to say,there are no differences in the results of Hamilton depression scale between 4 and 8 week taking medicine.So the result of treatment group decreased apparently than the control group.4.Comparison of PSQI scale in the groups:there are significant differences in the groups results compared with the pre and post treatment.But there are no significant differences between the two groups.It prompted that the results of post-treatments decrease than the results of pre-treatment.But the result after taking 4 weeks medicine decrease more apparently that the results of pre treatment.There are no apparent difference between the degree of serum 5-HT pre and post treatment(P>0.05).But the results of post control group are lower than the pre treatment.There are no significant difference in the degree of serum FSH and E2 pre and post treatment.It hints that there are no differences in sexua]hormone examination pre and post treatments.There are no abnormal results of safe examination pre and post treatment in the two groups.Conclusions:1.Both of the Shugan capsule and Deanxit can improve the symptoms of the depression and the symptoms of vegetative nerve functional disturbance,and the effects are nearly the same.2.Shugan capsule can inhibit the decrease of 5-HT.It hints that there are disturbance of serum 5-HT.Menopause depression' s etiological factor related to a lot of factors.5-HT is only one of the reference factors.FSH doesn' tdecreaseandE2doesn' t increase,it is considered that the menopause depression is related to the functional disturbance of gonadal axis.Shugan capsule can improve the symptoms of disturbance of neuroendocrine and has the function of anti-depression.3.The results of PSQI scale and Hamilton depression scale are nearly the same;they both can evaluate the clinical effects of depression.4.Shugan capsule' s effect is slow and lasting,the expense is lower. And side effects are lesser than Deanxit.In conclusion,Shugan capsule is safe and effective;it can be popularly used in clinical.