BackgroundDachaihu decoction (Dachaihu tang) plays a crucial role in treating acute illnesses. Recently, a significant number of clinical studies on Dachaihu decoction for acute cholecystitis (AC) have been published. This study was conducted to assess the efficacy and safety of Dachaihu decoction in patients with this condition.MethodsTo identify relevant randomized controlled trials (RCTs), eight databases and three clinical trial registries were searched from inception to 30 June 2024. Two researchers independently screened and extracted data from eligible studies using EndNote X9 and Microsoft Office Excel 2019. RoB 2.0 was used to assess the risk of bias in the included studies. Stata 17.0 was used for data analysis. Publication bias and its impact on result stability were evaluated using a funnel plot and the “trim-and-fill” method. The quality of evidence was graded using the GRADE assessment system.ResultsThirty-three RCTs involving 2,851 participants were included. The treatment group demonstrated improved clinical efficacy (RR = 1.18; 95% CI = 1.13 to 1.24), significantly reduced length of hospital stay (MD = −1.78 days; 95% CI = –2.02 to −1.53), and the incidence of adverse events (RR = 0.31; 95% CI = 0.20 to 0.48). Additionally, there appeared to be reductions in the time for abdominal pain to resolve (MD = −1.92 days; 95% CI = –2.33 to −1.51), fever to disappear (MD = −1.52 days; 95% CI = –1.90 to −1.14), white blood cell count to return to normal (MD = −2.89 days; 95% CI = –3.32 to −2.46), alanine aminotransferase (ALT) levels (MD = −11.88 U/L; 95% CI = –15.29 to −8.47), aspartate aminotransferase (AST) levels (MD = −8.74 U/L; 95% CI = –9.76 to −7.72), neutrophil percentage (MD = −9.68; 95% CI = –11.33 to −8.03), TNF-α levels (SMD = −2.10 pg/L; 95% CI = –2.43 to −2.78), and certainty of evidence (moderate-to-low certainty).ConclusionDachaihu decoction may be an effective botanical formula for managing AC and a lower incidence of adverse events. However, due to the substantial risk of bias and heterogeneity across the included studies, these findings should be interpreted with caution and require further validation through well-designed, high-quality trials.Systematic Review registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=573332.