Abstract
Introduction: Shaofu Zhuyu Decoction (SZD) is a traditional Chinese herbal formula commonly used for gynecological disorders involving "blood stasis" and lower abdominal pain. Although applied clinically for endometriosis, evidence regarding its efficacy and safety remains fragmented. This systematic review and meta-analysis aimed to evaluate the clinical efficacy and safety of SZD combined with conventional medication (CM) for the treatment of endometriosis. Methods: Databases including PubMed, EMBASE, CNKI, and Web of Science were searched from inception to May 2024 for randomized controlled trials (RCTs) comparing SZD + CM versus CM alone. Risk of bias was assessed using the risk of bias 2.0 tool. The primary outcome was total effective rate (TER); secondary outcomes included serum CA-125 levels, pain scores (VAS), recurrence rate, and adverse events. Results: Eleven RCTs (n = 1186 patients) were included. Meta-analysis showed that SZD plus CM significantly improved TER compared to CM alone (OR 1.15; 95% CI: 1.09-1.22; p < 0.00001). Reductions in CA-125 levels (OR -1.57; 95% CI: -2.18 to -0.95; p < 0.00001) and pain (VAS) scores (OR -4.90; 95% CI: -6.82 to -2.98; p < 0.00001) were also significant. Three studies reported lower recurrence in the SZD group. Adverse events were generally mild and comparable between groups. Conclusions: SZD combined with CM appears more effective than CM alone in improving endometriosis symptoms, reducing biochemical markers, and decreasing pain intensity, with acceptable safety. However, the findings are limited by methodological heterogeneity and geographic concentration of studies. Rigorous multicenter trials are warranted to support integration of SZD into global endometriosis care.