Objective: To assess and compare the efficacy and safety of Ganmai Dazao Tang(GMDZD) and antidepressants for depression. Method: The randomized controlled trials (RCTs) about GMDZD for depression were searched in the databases of EMBASE

PubMed

The Cochrane Library

China National Knowledge Infrastructure

Wanfang Data

Chinese Biomedical Literature Database

and VIP Information. Two reviewers independently screened the literatures

extracted the data

and evaluated the methodological quality. Meta-analyses were performed by using RevMan 5.2 software. Result: A total of 14 RCTs involving 1 105 cases were included. Meta-analyses suggested that compared with simple administration with antidepressants

GMDZD combined with antidepressants showed a significantly greater reduction in HAMD scores [MD=-3.46

95%CI(-4.66

-2.26)

P<0.000 01]. There was no significant difference in HAMD scores between the simple administration with GMDZD and antidepressants [MD=-0.98

95%CI(-2.59

0.63)

P=0.23]. GMDZD group was comparable with antidepressants group in the total effective rate. No serious adverse events were reported in all of the included trials. Pooled analyses of adverse events in 7 trials [RR=0.16

95%CI(0.09

0.30)

P<0.000 01] and TESS scores of 2 trials [MD=-8.2

95%CI(-9.69

-7.74)

P<0.000 01] suggested that GMDZD group had less adverse effects compared with antidepressants group. Conclusion: The present evidence suggests that GMDZD was effective and safe for patients with depression. However

due to the low quality of trials included

more high-quality RCTs are required to verify the results.