OBJECTIVE: To systematically assess the clinical effectiveness of traditional Chinese medicine (TCM) in the treatment of functional dyspepsia (FD) of liver-stomach disharmony syndrome by meta-analysis. METHODS: Random controlled trials (RCTs) were retrieved from databases, including Pubmed, China national knowledge infrastructure, Wanfang Data, VIP Information, and the Cochrane Library. Trials were selected according to inclusion criteria. The effects of traditional Chinese medicine (TCM) versus prokinetic agents in the treatment of functional dyspepsia (FD) of liver-stomach disharmony syndrome were compared by meta-analysis. RevMan 5.0.24 was used for data analysis. The effective rate was assessed by odds ratios (ORs), and 95% confidence intervals (CIs) were calculated. The cure rate was analyzed by the Peto OR. Simple statistical analysis was chosen to assess the frequency of prescribed Chinese herbs in treating this syndrome. RESULTS: Thirteen trials were included, involving 1153 patients, and these were of poor methodological quality. Twelve studies mentioned the effective rate and cure rate. TCM therapy showed a better clinical effect rate compared with that with prokinetic agents [OR: 3.2, 95% CI (2.27, 4.51)]. The TCM group also had a better cure rate than that in the group of prokinetic agents [Peto OR: 2.26, 95% CI (1.61, 3.18)]. With regard to the frequency of Chinese herbs used in these 13 trials, Baishao (Radix Paeoniae), Chaihu (Radix Bupleuri), and Gancao (Radix Glycyrrhizae) were mostly prescribed, followed by Xiangfu (Rhizoma Cyperi), Zhishi (Fructus Aurantii Immaturus), Zhiqiao (Fructus Aurantii), Foshou (Citrus medica var. sarcodactylis), and Chenpi (Pericarpium Citri Reticulatae). No serious adverse effects were reported. CONCLUSION: TCM therapy shows a superior effective rate and cure rate compared with those in prokinetic agents in the treatment of FD of liver-stomach disharmony syndrome. However, further strictly designed RCTs are required because of the poor quality of included trials.