| Objects: To Study and observe the clinical efficacy of treating depression with Shugan Jieyu Capsules, to compare the differences between Shugan Jieyu Capsules and Sertraline in efficacy; to provide supports for screening of clinical medication.Methods:This study was based on the criteria for the depressive episode diagnosis in ICD-10, with HAMD score≥18 points and SDS scale score≥53 points as the inclusion criteria, it formulated an unified Exclusion criteria. Selected 80 cases in accordance with the diagnostic criteria, inclusion criteria and exclusion, and divided them into two equal parts by digital random table, ie, group of Shugan Jieyu Capsules(Treatment Group ie TG) 40 cases, group of Sertraline (Comparison Group ie CG) 40 cases. After a 6-week Clinical observation, the treatments of totally 75 cases including 37 cases from TG and 38 cases from CG were completed in effect. Treatment protocols: Give TG Shugan Jieyu capsules (360mg / tablets) 2 tablets once every morning and evening; Give CG Sertraline capsules according to the initial dose 50 mg / d and then 100 mg / d to the maximum dose 200mg/d within 2 weeks, it was once every morning. All patients were scored by HAMD scale, SDS scale before treatment, after 2 weeks, 4 weeks and 6 weeks, furthermore, they were assessed by TESS and tested according to laboratory safety indicators.Result:The overall efficacy of HAMD scale indicated: The total effective rate of TG was 72.97%, whereas CG was 81.57%; The overall efficacy of SDS scale indicated: The total effective rate of TG was 78.37%, whereas CG was 81.57%; Above statistics showed no significant difference between the two groups (p> 0.05). The HAMD score comparison before and after treatment showed: The scores of TG after 4 weeks, 6 weeks (15.84±2.89,10.05±4.12) were significantly lower than the scores before treatment(24.81±7.41) p<0.01; The scores of CG after 4 weeks, 6 weeks (13.09±3.51,9.62±3.24) were remarkably lower than the scores before treatment(24.70±6.81) p<0.01; As for each group, Above statistics showed no significant difference between the two groups (p> 0.05).The SDS score comparison before and after treatment showed: The scores of TG after 2 weeks, 4 weeks, 6 weeks (49.85±8.64,46.37±8.25,42.75±9.02) were apparently lower than the scores before treatment(69.62±13.76) p<0.05\p<0.01; The scores of CG after 4 weeks, 6 weeks (44.72±7.28,40.83±7.32) were remarkably lower than the scores before treatment(70.35±14.38) p<0.01; As for each group, there were significant differences (p<0.05) compared the treatment of 6 weeks with 2 weeks. The comparison of factors in HAMD scale between both groups indicated: After a six-week treatments, except the weight factors, anxiety / somatization factors, retardation factors and sleep disturbance factors were all significantly lowed to p<0.05 or p<0.01; By comparison, there were no remarkable differences in all factors between both groups before treatments p>0.05, after a 6-week treatments, anxiety / somatization factors (TG:1.97±1.04,CG:2.52±1.17), retardation factors(TG:3.06±1.87,CG:2.18±0.68), and sleep disturbance factors(TG:2.12±0.94,CG:3.18±1.13) were significantly different by comparison, p<0.05 or p<0.01. Judged from the onset time, both groups didn't indicate any significant differences p>0.05. Comparison between both groups in treating different degrees of depression showed: In the treatments of mild to moderate depression, no significant differences occurred between two groups p>0.05, while for the efficacy of severe depression, the differences were significant.Conclusion:1. The overall efficacy of Shugan Jieyu capsules and Sertraline in treatment of mild to moderate depression is similar.2. Shugan Jieyu capsules are inferior to Sertraline in the treatment of severe depression.3. In clinical medication selection, Shugan Jieyu capsules may be the preferred drug for the mild to moderate depression, especially those patients whose anxiety/somatization factors and sleep disturbance factors scored higher when measured by HAMD scale, otherwise those whose retardation factors are higher may use Sertraline. |
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