| Objective:The purpose of this paper is to evaluate the clinical efficacy and safety of Shugan Jianpi therapy in the treatment of ulcerative colitis by Meta analysis,and to provide guidance for the clinical application of ulcerative colitis.Method: Seven databases of CNKI,Wanfang Data,VIP Data,CBM,Pub Med,Embase and Cochrane Library(up to January 9,2021)were searched to collect the randomized controlled trials(RCTs)of Shugan Jianpi therapy for the patients with ulcerative colitis of liver depression and spleen deficiency.A comprehensive search was conducted on the clinical randomized controlled trials of Shugan Jianpi therapy in the treatment of ulcerative colitis.According to the inclusion criteria and exclusion criteria,two evaluators screened the literature,extracted the data,and evaluated the quality of the literature.The Rev Man5.3 software provided by Cochrane collaboration network is used for Meta analysis,and finally the results of system evaluation are discussed.Result: 1026 related literatures were retrieved,and finally 30 articles were included for Meta analysis,including 2031 patients in the treatment group(n=617),the control group(n=606),the Shugan Jianpi therapy combined with western medicine routine treatment group(n=406)and the control group(n=402).The results of Meta analysis showed that compared with the control group,the Shugan Jianpi therapy in the treatment of ulcerative colitis was superior to the routine treatment of western medicine in improving the total clinical effective rate(OR=3.27,95%CI[2.31,4.64],Z=6.64,P < 0.00001),cure rate(OR=2.15,95%CI[1.42,3.26],Z=3.61,P=0.0003 < 0.01),general TCM symptoms(WMD=-4.05,95%CI[-5.92,-2.19],Z=4.26,P<0.0001),abdominal pain,chest distension pain and abdominal distension symptoms.The Shugan Jianpi therapy can significantly reduce the level of interleukin-8(SMD=-2.04,95%CI[-2.53,-1.55],Z=8.13,P<0.00001)and tumor necrosis factor-α(SMD=-2.71,95%CI[-4.35,-1.07],Z=3.24,P=0.001<0.01)and increase the level of interleukin-10(SMD=1.23,95%CI[0.91,1.55],Z=7.54,P<0.00001)in patients with ulcerative colitis.It has obvious advantages in reducing the incidence of adverse reactions(OR=0.17,95%CI [0.06,0.46],Z=3.52,P=0.0004<0.01),colonoscopy score,improving anxiety and depression,improving quality of life and so on.However,there was no significant difference between the Shugan Jianpi therapy group and the western medicine routine group in improving the level of interleukin-6,reducing the degree of disease activity,reducing the recurrence rate and improving the healing of intestinal mucosa.Compared with the routine treatment of western medicine,the Shugan Jianpi therapy combined with western medicine has obvious advantages in improving the total clinical effective rate(OR=3.73,95%CI[2.24,6.21],Z=5.04,P < 0.00001),cure rate(OR=2.72,95%CI[1.82,4.05],Z=4.91,P < 0.00001),improving the overall symptoms of traditional Chinese medicine(WMD=-2.70,95%CI[-3.94,-1.46],Z=4.27,P<0.0001),abdominal pain and diarrhea.Combined therapy can significantly reduce the degree of disease activity(WMD=-1.37(95%CI[-1.81,-0.93],Z=6.13,P<0.00001),improve colonoscopy score(WMD=-0.92(95%CI[-1.33,-0.51],Z=4.40,P<0.0001)and improve depression,but it is similar to the control group in reducing erythrocyte sedimentation rate,C-reactive protein,incidence of adverse reactions and improving anxiety in patients with ulcerative colitis.Combined therapy can significantly reduce the recurrence rate.Generally speaking,the Shugan Jianpi therapy has obvious clinical effect in the treatment of ulcerative colitis.Conclusion:The Shugan Jianpi therapy in the treatment of ulcerative colitis is better than that of western medicine alone,which can improve the clinical effect and improve the symptoms.However,there are few reports on recurrence rate,incidence of adverse reactions,levels of inflammatory factors,nitric oxide,superoxide dismutase,number of intestinal flora,Baron endoscopic score,lymphocyte subpopulation,intestinal mucosal barrier function index and intestinal mucosal symptoms,lack of long-term follow-up data.The original literature lacks reports on other indicators(disease activity index,coagulation function index,histopathological improvement,etc.),and the quality of the original literature is low and the risk of bias is high,which affects the accuracy and reliability of the results. |