The Effectiveness Of Fluoxetine Combined With Shuganjieyu Capsule On Depressed Patients With Insomnia

BackgroundDepression is a kind of syndrome characteristic of low mood, with clinical manifestation of emotional depression, slow thinking, declined volitive activity and physical symptoms. The depression has become a common disease, frequently-occurring disease nowadays, in which the depression with insomnia stands out. As for depression pathogenesis and drug intervention strategies, the research progress of traditional Chinese medicine treatment of depression have been attended extensively by experts in the field of mental health. The traditional Chinese medicine treatment on depression has advantages of multiple pathways, targets, multi-level treatment, and with sedative effects of traditional Chinese medicine generally have no obvious dependence, etc. The clinical application of the new Chinese medicine treatment of depression has become a hot topic in the field.Objective1. To investigate the effectiveness, side-effect of Fluoxetine combined with Shuganjieyu capsule and slumber influence in depressed patients with insomnia.2. To investigate changes of sleep electroencephalogram (EEG), Pittsburgh sleep quality index (PSQI) in depressed patients with insomnia under the influence of Fluoxetine combined with Shuganjieyu capsule.3. To investigate the treatment effect of Fluoxetine combined with Shuganjieyu capsule in depressed patients with light-moderate insomnia.MethodsA Case-control study method was adopted. According to the "International Classifica-tion of Diseases (10th Edition) "(ICD-10) and "Chinese Internal Medicine" on the diagnosis of depression, the patients were separated into study group (29 cases treated with Fluoxetine dispersible tablet and Shuganjieyu capsule) and control group (29 cases treated with Fluoxetine). The Hamilton depression scale (HAMD), treatment emergent symptom scale (TESS) were used to evaluate the curative effect and adverse reaction, and sleep electroencephalogram, Pittsburgh sleep quality index (PSQI) were investigated to analyze their effects on insomnia.Results1. The HAMD results:the HAMD deduction rate was calculated as follows:HAMD deducted rate= [(score before treatment-score after treatment)/score before treatment by 100%]. The patient was clinically recovered (the score was≥75%), and remarkably progressive (≥50%), improved (≥25%), and invalid (<25%), respectively. The total effective rate=[(recovered+significantly progressive+improved)/total] x 100%.29 cases were included in study group,29 cases in control group. After treatment in both groups, the total effectiveness rates were 93.1%in study group and 82.2%in control group, and significant difference was observed (x2=3.432; P=0.042). Two groups of HAMD score before treatment there was no significant difference (t= 0.702; P= 0.465), the HAMD score comparison before and after the study group and control group are significant difference (F=3.97,P=0.000; F=3.96, P=0.010), in 2 weeks,4 weeks,6 weeks HAMD score had significant difference (t=2.436, P=0.022;t=2.667, P=0.015; t=2.395, P =0.022), the two groups in 2 weeks,4 weeks,6 weeks HAMD deducted rate had significant difference (t=2.396, P=0.025;t=2.867, P=0.006;t= 3.355, P=0.001).2. Study group and control group in the treatment of PSQI score before there was no significant difference (t= 0.710, P=0.455), PSQI score comparison before and after the study group and control group are significant difference (F=3.99, P=0.000; F=3.96, P =0.010), in 2 weeks,4 weeks,6 weeks PSQI score had significant difference (t=2.436, P = 0.022; t=2.667, P=0.015; t=2395, P=0.022), the two groups in 2 weeks,4 weeks, 6 weeks PSQI deducted rate had significant difference (t=2.396, P=0.025;t=2.867, P =0.006;t=3.355,P=0.001).3.Study group and control group in the treatment group before and after the total sleep time has significant difference compared(t=3.241,P=0.002;t=3.232,P=0.003), there was no significant difference between group and the control way(t=1.376,P= 0.153;t=1.567,P=0.130).The two groups before treatment S1,S2,S3+S4,there was no significant difference were observed in the incubation period of REM(t=0.848, P= 0.411;t=1.297,P=0.220;t=1.765,P=0.115;t=1.367,P=0.132),the two groups after treatment of S1,S2,S3+S4,there are significant difference between the incubation period of REM groups(t=2.662,P=0.012;t=2.008,P=0.021;t=2.675,P=0.015; t=2.573,P=0.018).4.The incidence of adverse reactions was 27.6% in study group and 31.0% in control group,respectively.There was no significant adverse reactions similar between the two groups(x2=0.58,P=0.482).Conclusion1. Fluoxetine combined with Shuganjieyu capsule seemed more effective than Fluoxetine.2.Fluoxetine combined with Shuganjieyu capsule was more capable to reduce the S1, S2 slumber time and to extend the S3+S4,REM latency time than Fluoxetine.3.Non-significant increase of adverse reactions has been observed with the use of Fluoxetine combined with Shuganjieyu capsule.4. The Fluoxetine combined with Shuganjieyu capsule had better effect on mild-to-moderate depressed patients with insomnia than the Fluoxetine.