To evaluate the efficacy and safety of Ganmai Dazao (GMDZ) decoction alone and in combination with antidepressant medication or psychotherapy for depression.

We searched seven electronic databases from inception to December 2025. Two assessors extracted the data and independently evaluated the methodological quality using the Cochrane risk of bias assessment.

A total of 35 randomized controlled trials involving 3187 patients were included. Meta-analysis demonstrated that GMDZ decoction, either as monotherapy or in combination with antidepressants/psychotherapy, significantly reduced Hamilton Depression Scale (HAMD) scores (GMDZ group: standardized mean difference [SMD]: −0.63, 95% confidence interval [CI]: −1.01 to −0.26; combination therapy group: SMD: −1.87, 95% CI: −2.44 to −1.30), Hamilton Anxiety Scale scores (combination therapy group: mean difference [MD]: −4.23, 95% CI: −5.89 to −2.57), and Pittsburgh Sleep Quality Index scores (GMDZ group: MD: −3.56, 95% CI: −4.14 to −2.99; combination therapy group: MD: −3.60, 95% CI: −5.87 to −1.32), all statistically significant (P <.05). This effectively alleviated depressive and anxiety symptoms while improving sleep quality, with the combination therapy demonstrating greater efficacy in reducing HAMD scores. Regarding safety, adverse events primarily included nausea and dry mouth. The overall quality of the evidence was low.

GMDZ decoction effectively alleviated symptoms of depression and anxiety while improving sleep quality, with combination therapy demonstrating more pronounced effects in reducing HAMD scores. However, the included studies exhibited considerable heterogeneity, with some lacking clear allocation, concealment, or blinding protocols. More high-quality, large-sample, multicenter, randomized controlled trials are needed for further validation, given these limitations.