Abstract:Objective To investigate the clinical effect and safety of Zhizhu Kuanzhong Capsule in the treatment of functional dyspepsia (FD). Methods Randomized controlled trials (RCTs) of Zhizhu Kuanzhong Capsule in the treatment of FD were screened out and related data were extracted. The Cochrane tool for assessing the risk of bias was used for methodological quality assessment, and Revman 5.0 was used for the meta-analysis. Results A total of 21 RCTs were included, with a total of 2 399 patients, and the quality of these articles was low. The meta-analysis showed that Zhizhu Kuanzhong Capsule had a significantly better overall response rate in the treatment of FD than prokinetic drugs [risk ratio(RR)=1.15,95% confidence interval(CI): 1.04 to 1.26;Z=2.72, P=0.007\]; Zhizhu Kuanzhong Capsule combined with prokinetic drugs had a significantly better effect in the treatment of FD than prokinetic drugs alone (RR=1.28,95% CI: 1.18 to 1.39;Z=5.81, P=0.000); Zhizhu Kuanzhong Capsule combined with antidepressants had a significantly better effect in the treatment of FD than antidepressants alone (RR=1.38, 95% CI: 1.21 to 1.56;Z=4.98, P=0.000); Zhizhu Kuanzhong Capsule combined with acid inhibitors had a significantly better effect in the treatment of FD than acid inhibitors alone (RR=1.25, 95% CI: 1.09 to 1.43;Z=3.16, P=0.002). In addition, compared with prokinetic drugs, Zhizhu Kuanzhong Capsule had significantly better effects in improving abdominal distension and stomachache in patients with FD [abdominal distension score: mean difference (MD)=-0.75, 95% CI:-1.20 to -0.31,Z=3.30, P=0.001; stomachache score: MD=-0.60, 95% CI:-0.91 to -0.30, Z=3.88, P=0.000\]. Conclusion Zhizhu Kuanzhong Capsule alone or combined with Western medicine treatment can improve the clinical outcome of FD and relieve the digestive symptoms such as abdominal distension and stomachache, but high-quality clinical trials are needed to further validate its clinical effect.