| Objectives:1. To evaluate the curative effect of Bushen Shugan Huayu decoction used to treat menopausal depression and the intervention to sex hormones and brain neurotransmitter levels by prospective randomized study.2. To discuss the possible mechanism by analyzing the changes of levels of sex hormones and brain neurotransmitter after treatment.Methods:According to visiting sequence and following the principles of randomized controlled,64menopausal depression patients who were in accordance with the inclusion criteria were divided into two groups:TCM treatment group (Hereinafter referred to as the treatment group) and western medicine control group (Hereinafter referred to as the control group). The patients in treatment group were treated by Bushen Shugan Huayu decoction, and other patients were given orally Paroxetine hydrochloride tablets,8weeks as a course. Hamilton Depression Scale (HAMD), Kupperman score sheet and TCM syndrome score sheet were used to used to evaluate the clinical efficacy. Sex hormones and brain neurotransmitter levels were detected both before and after treatment. Finally, we will explore the clinical efficacy and possible mechanism by the statistical analysisResults:1. The evaluation of clinical efficacy based on HAMD Scale:According to the score-reducing rates of HAMD Scale, the total efficiency of the treat group is greater than that of the control group, but the difference is not statistically significant(P>0.05).2. The evaluation of clinical efficacy based on TCM syndrome score sheet: According to the score-reducing rates of TCM syndrome score sheet, the total efficiency of the treat group is greater than that of the control group, and the difference is statistically significant (P<0.01).3. Comparison of the HAMD scores between both groups before and after treatment: The difference is significant in both groups after treatment. Compared with difference in the treatment and control groups before and after treatment, there is no significant difference(P>0.05). It’s not so obvious in improving the patients with low mood and depressive symptoms between both groups4. Comparison of the KMI scores before and after treatment between both groups There is statistical difference of KMI scores in both groups after treatment. Compared with difference in the treatment and control groups before and after treatment, there is significant difference(P<0.01). In improving patients’ symptoms of menopause, the treatment group is better than the other one.5. Comparison of the TCM syndrome scores before and after treatment between both groups:Contrast before and after treatment, there is no statistical difference of TCM syndrome scores in the control group(P>0.05), while difference in the treatment group has statistical signif icance(P<0.01). From the difference of the two groups before and after treatment, we can see statistical difference(P<0.01). Thus in improving patients’physical symptoms, the treatment group is better than the control group.6. Comparison of the HAMD factor scores before and after treatment between both groups:The factors which have significant difference after treatment in the control group are disorder of understanding, disorder of sleep and hopelessness. The factors which have significant difference after treatment in the treatment group are anxiety, weight, and block and sleep disorders. After treatment, the factors which have significant difference between both groups are anxiety, weight and block.7. Comparison of the sex hormones levels before and after treatment between both groups:Contrast before and after treatment, there is no statistical difference of sex hormones levels in the control group(P>0.05), whi le difference of E2and FSH in the treatment group has statistical signi f icance (P<0.01), but the LH level has no statistical changes in both groups8. Comparison of the brain neurotransmitter levels before and after treatment between both groups:Both groups have improved in the EEG, and the treatment group is better than the control group.9. Safety result shows:Patients in treatment groups are not found uncomfortable symptoms. Two cases in the control group appeared transient nausea and dizziness,but they are relieved after expectant treatment.There’s no obviously abnormal in all cases in safety index such as blood, urine and stool routine, hepatic and renal function and ECG.Conclusions:1. Bushen Shugan Huayu recipe, which can tonic kidney and circulate blood has achieved good effect in treating menopausal depression, especially in improving the somatic symptoms 2. Bushen Shugan Huayu recipe can adjust the level of E2and FSH of menopausal depression patients.3. The possible mechanism of Bushen Shugan Huayu recipe is that it can adjust the function of hypothalamic-pituitary-ovarian axis.4. Bushen Shugan Huayu recipe used to treat menopausal depression can improve patients’symptoms. Furthermore, its security is good. Bushen Shugan Huayu recipe has the broad application prospect. |
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