A meta-analysis of Xin kai bitter method in the treatment of functional dyspepsia

Background: Functional dyspepsia (FD) is a common, etiologically complex disease which persistently and recurrently attacks the digestive system. However, the efficacy of Western medicine in treating FD is unsatisfactory and its use is often accompanied with severe side effects. Here, this study conducted a meta-analysis on the clinical efficacy and safety of the treatment of FD with Xin kai bitter method combined with Western medicine, to produce a more objective and comprehensive systematic review to guide clinical application. Methods: Systematic searches were conducted of the PubMed, Cochrane Library, EMBASE, Medline, Web of Science, Wanfang Databases, and Weipu (VIP) databases, as well as China National Knowledge Infrastructure (CNKI). Randomized controlled clinical trials (RCTs) of Xin kai bitter method in the treatment of FD were included in the study. The total effective rate and safety were evaluated with relative risk (RR) and the quantitative data were evaluated with standard mean difference (SMD) and 95% confidence interval (CI). The quality of the included literature was evaluated using RevMan5.3 software, and the "meta" package of R3.5.1 software was used for all other statistical analysis. Results: A total of 24 papers involving 1,044 patients in the treatment group and 989 patients in the control group were included. A total of 23 articles reported the total effective rate after 1 month of treatment (I-2=0%), and the total effective rate in the treatment group was 1.21 times higher than that in the control group (95% CI: 1.17 vs. 1.26). A total of 4 articles reported the safety rate after 1 month of treatment (I-2=27%); the safety rate in the treatment group was 0.43 times than that in the control group (95% CI: 0.23 vs. 0.82). A total of 8 articles reported traditional Chinese medicine (TCM) symptom score or clinical symptoms before and after 1 month of treatment (I-2=91%), and the difference in TCM symptom score before and after treatment in the treatment group was significantly lower than that in the control group, with a SMD of -1.19 (95% CI: -1.71, -0.66). A total of 6 articles reported the motilin (MTL) level before and after 1 month of treatment, and the difference before and after treatment in MTL in the treatment group was not significantly different to that in the control group, with a SMD of 0.92 (95% CI: -0.12, 1.97). Conclusions: Compared to conventional treatment, Xin kai bitter method has a higher clinical effect and lower adverse reaction rate in patients with FD, and can improve TCM symptom score. However, high-quality RCT research is still needed to further explore the safety of Xin kai bitter method for treating FD.