Abstract: Objective To evaluate Fuzilizhong decoction and its modified decoction systematically and summarize the clinical efficacy and safety of the treatment of ulcerative colitis. Methods According to the Cochrane system evaluation method, we searched the database of CNKI,VIP and Wanfang as well as in PubMed,EMBase,Medline,Cochrane Library database to search some randomized controlled trials and a semi randomized controlled trials of Fuzi Lizhong Decoction and its addition and subtraction in the treatment of ulcerative colitis. For eligible RCT, after data extraction and quality evaluation, RevMan 5.3 software was applied in Meta analysis, and GRADE system was used to score the quality and grade recommendation. Results A total of 8 eligible RCT studies were included, with a total of 688 patients participating in qualified clinical studies, but their methodological quality was poor. Meta analysis showed that the total effective rate was OR combined with OR=4.32［OR=4.32, 95%CI(2.55, 7.31), P<0.000 01］. Fuzilizhong decoction had no obvious adverse reactions in the treatment of ulcerative colitis, and had good safety. The results of GRADE system evaluation showed that the level of evidence was B, and the recommendation level was weak recommendation. Conclusion The effective rate of Fuzi Lizhong Decoction and its addition and subtraction therapy is higher than that of western medicine alone, and it had high safety and no obvious side effects. Due to the low quality of the clinical controlled studies, the curative effect of Fuzilizhong decoction and its addition and subtraction prescription on ulcerative colitis is still unable to make the final conclusion. More high-quality RCT is needed to get a positive conclusion.

Key words: Fuzilizhong decoction, ulcerative colitis, meta analysis, systematic evaluation, GRADE system