| Objective:To investigated the efficacy of the ZiShenYiGan(tonifying Kidney and Liver)method,on the patients with depression and insomnia and had been diagnosed with GanShenYinXu(Liver and Kidney Yin deficiency)syndrome,a combination of Yinhuo Decoction and Dabugan Decoction were investigated as an representative.Methods:A randomised controlled trial were conducted based on Qingdao Chinese Medicine hospital(Qingdao Hiser Hosipital).Sixty adults with depression and insomnia were recruited from both inpatient and outpatient department.They were randomly assigned to the treatment group(Dabugan Decoction and Yinhuo Decoction,n=30)and control group(mirtazapine 15mg,n=30).Both groups were intervened for 14 days.The effectiveness rate,Traditional Chinese Medicine syndromes,Self-rating Depression Scale(SDS),Pittsburgh Sleep Quality Index(PSQI),monoamine neurotransmitter levels(including 5-hydroxytryptamine(5-HT),norepinephrine(NE)and dopamine(DA))were measured.Data were collected at the baseline and on 7th and 14th day of intervention.Safety was also assessed.Results:1.The total effectiveness rate of sleep improvement in the treatment group was 90.00%(27/30),lower than that in the control group(93.33%,28/30,P<0.05).The total effectiveness rates of the improvement of depressive symptoms in both groups were 100%(30/30).The total effectiveness rate of the improvement of Liver and Kidney Yin deficiency symptoms in the treatment group was 100.00%(30/30)(P<0.05),higher than that in the control group(96.67%,29/30,P<0.05);2.The PSQI of patients in the treatment group and the control group were(8.93±1.53)and(8.13±1.33)on the 7th day of treatment,(5.23±1.65)and(7.03 ± 1.35)on the 14th day of treatment,respectively.Those in the control group were lower than in the treatment group on the 7th day(P<0.05.The PSQI in the control group decreased significantly compared with that in the 7th day before treatment,but no further improvement after the first week(P>0.05);3.The SDS of patients in the treatment group was lower than that in the control group(P<0.05);4.The score of TCM syndrome in the treatment group was significantly lower than that in the control group(P<0.05);5.The levels of 5-HT,DA and NE in both groups were higher than those at the baseline(P<0.05);6.The DA level in the treatment group was significantly lower than that in the control group(P<0.05);the 5-HT level in the treatment group was lower than that in the control group on the 7th day(P<0.05);the NE level in the treatment group was significantly higher than that in the control group(P<0.05).Conclusion:When compared to mirtazapine,the combination of Yinhuo Decoction and Dabugan Decoction could improve the clinical symptoms of depression and insomnia in adults with GanShenYinXu syndrome,increase the level of some monoamine neurotransmitters(5-HT,DA,NE)in patients’serum,reduce the PSQI and SDS,and eliminate the patients’ TCM symptoms.The mechanism of the combined formula,as a representative of ZiShenYiGan(tonifying Kidney and Liver)method,may be related to the upregulation of monoamine neurotransmitter levels. |