Abstract: OBJECTIVE To systematically review the effectiveness and safety of amitriptyline in the treatment of functional dyspepsia(FD). METHODS Databases including PubMed, Cochrane Library, Web of Science, Embase, CNKI and Wanfang Data were searched from inception to April 2019 to collect randomized controlled trials about the effectiveness and safety of amitriptyline in the treatment of FD. Meta-analysis was performed by using RevMan 5.3 software. RESULTS A total of 41 randomized controlled trials, concerning 4 477 FD patients were included, in which contained 2 250 in experiment group and 2 227 in control group. The results of meta-analysis showed that the overall effective rate of amitriptyline combined with gastric motility drugs and/or PPI in the treatment of functional dyspepsia was significantly higher than that of the control group (P<0.05), and could improve some symptoms such as abdominal distention, nausea and vomiting, and heart reacid(P<0.05). In addition, the incidence of ADR in amitriptyline combined with gastric motility drugs and/or PPI had no significant difference with the control group. CONCLUSION Amitriptyline combined with gastric motility drugs and/or PPI has certain efficacy and tolerable adverse reactions in the treatment of FD. However, due to the low quality of the existing randomized controlled trials, it is suggested that patients with chronic FD should assess the psychiatric symptoms to determine whether amitriptyline can be combined in the treatment of FD. Futhermore, more high-quality studies are needed to determine the efficacy and safety of amitriptyline and better guide clinical decision-making.