| Objective To systematically review the clinical effects and safety of Bupleurum Falcatum Plus Dragon Bone and Oyster Shell Decoction(CJLM)for patients with poststroke depression and provide valid evidence-based basis for further clinical application.Methods Having formulated the inclusion and exclusion criteria,collected all randomized controlled trials(RCTs)for the treatment of post-stroke depression with Bupleurum Falcatum Plus Dragon Bone and Oyster Shel lDecoction by means of computer search cooperate with manual retrieval.Mainly Four databases included CNKI,VIP,Wan-fang,Chinese biomedical literature database(CBM)and Pub Med were searched up to December 2017.Two researchers selected literature singly and extracted data from these literature by EXCEL tables.The Cochrane system evaluation manual was applied to evaluate the inclusion literature,Sensitivity analysis,Publication bias and Heterogeneity test were analysized by the Review Manager 5.3 software,include total effective rate,the changes of Hamilton depression scale score,nerve Function defect grade(such as Improved Edinburgh-Scandinavia score(MESSS),China clinical neurological deficit of stroke patients standard for evaluation(CSS),National institutes of health stroke scale(NIHSS),Daily activity ability(ADL)scale(Barthel index),Change of TCM symptom score and adverse event.Interpreted forest maps what we finally got from the analysis,and Test for publication bias using funnel plots,all these were working for the Clinical evaluation of Bupleurum Falcatum Plus Dragon Bone and Oyster Shell Decoction in the treatment of post-stroke depression for therapeutic effect and safety.Result After rigorous screening,25 randomized clinical trials which owned the total number of cases in 1930 were selected in the end.The results of Meta analysis shows that 21 studies compared the clinical effective rate,in the subgroup analysis stratified by thedifferent standards and different intervention methods for total effective rate,Bupleurum Falcatum Plus Dragon Bone and Oyster Shell Decoction have a greater advantage in the total effective rate of post-stroke depression compared with control group,there were statistically significant differences in [different standards:RR = 1.17,95%CI(1.11,1.11),P<0.000 01.Different intervention methods:RR=1.17,95%CI(1.08,1.27),P<0.000 1],the result are robust.HAMD scores were reported in 20 studies to evaluate the depression,in the subgroup analysis stratified by the different intervention time and different intervention methods for the HAMD scores,the meta analysis shows that the experiment group can obviously reduce the HAMD scores which is superior to the control group,there were statistically significant differences in [different intervention time:SMD=0.77,95%CI(0.55,1.0),P=0.000 01;different intervention methods:SMD=0.66,95%CI(0.45,0.87),P=0.000 01].In terms of improving the daily living activity scale(BI)scores,four studies combined effect to the analysis,the difference was not statistically significant(P=0.35).Five studies reported the NIHSS score before and after therapy,the results of the analysis shows that Bupleurum Falcatum plus Dragon Bone and Oyster Shell Decoction has obvious advantages in reducing the NIHSS score compare to the control group,there were statistically significant differences in [SMD = 0.53,95%CI(0.29,0.77),P < 0.000 1];4 studies reported the MESSS scores,meta analysis shows that Bupleurum Falcatum plus Dragon Bone and Oyster Shell Decoction can reduce the CSS score better than the control group,there were statistically significant differences in [SMD=0.42,95%CI(0.19,0.66),P=0.000 3];5 studies reported the CSS scores,It can be assumed that Bupleurum Falcatum plus Dragon Bone and Oyster Shell Decoction can improve the degree of neurological defect after treatment more obviously than the control group,there were statistically significant differences in [SMD=0.98,95%CI(0.75,1.21),P<0.000 01];2 studies reported the TCM symptom score,The results showed that the experimental group was superior to the control group in improving the symptom score of TCM,and the difference was statistically significant[SMD=1.14,95%CI(0.85,1.42),P<0.000 01];Eight studies reported the specific adverse reactions,and the results showed that the adverse reactions ofBupleurum Falcatum plus Dragon Bone and Oyster Shell Decoction were less than that of the control group,and the difference was statistically significant [RR=0.23,95%CI(0.08,0.65),P=0.006]。Conclusions Bupleurum Falcatum Plus Dragon Bone and Oyster Shell Decoction shows a definite effect in the treatment of PSD,and the risk of adverse reaction is small,which is worthy of extensive clinical application.However,the reliability of the meta analysis conclusion can be influenced because of the low quality of the research and the certain risk of bias.Looking forward to the future that it can be more high quality,large sample,multicenter and scientifically rigorous randomized controlled trial to improve the update system evaluation to verify the clinical curative effect of Bupleurum Falcatum Plus Dragon Bone and Oyster Shell Decoction for the treatment of PSD. |