Abstract
OBJECTIVE: To systematically assess the safety and effectiveness of Compound E'jiao Jiang (, CEJ) for treating leukopenia. METHODS: Four English and four Chinese databases were searched for randomized controlled trials (RCTs) on CEJ for treating leukopenia up to July 1, 2024. Two researchers independently screened the studies and extracted necessary data. Methodological quality and risk of bias were assessed using the Cochrane risk-of-bias tool. Articles eligible for Meta-analysis were analyzed using RevMan. RESULTS: A total of 28 RCTs involving 2041 participants were included, with 1034 in the experimental group and 1007 in the control group. The Meta-analysis showed a significant effect of CEJ in treating leukopenia caused by tumor and immune diseases (three RCTs) [risk ratio (RR) = 1.17, 95% confidence interval (CI) (1.08, 1.27), P= 0.0002, I 2 = 35%]. The combination of CEJ and Western Medicine showed superior results in terms of white blood cell (WBC) counts (fifteen RCTs) [mean difference (MD) = 1.12, 95% CI(0.83, 1.42), P< 0.000 01, I 2 = 88%], Karnofsky Performance Status (KPS) levels (seven RCTs) [RR = 1.39, 95% CI(1.25, 1.55), P <0.000 01, I 2 = 36%], and mitigation of bone marrow toxicity (eleven RCTs) [RR = 0.61, 95% CI(0.54, 0.69), P < 0.00001, I 2 = 24%] compared to Western Medicine alone. Adverse events mainly included gastrointestinal and digestive reactions associated with chemotherapy drugs. CONCLUSION: CEJ alone or in combination with Western Medicine for treating leukopenia caused by tumor and immune diseases improved WBC counts, clinical efficacy, and quality of life. It also reduced bone marrow toxicity-induced leukopenia, enhanced the efficacy of chemotherapy while reducing its toxicity, and alleviated symptoms. No significant adverse events were reported in the RCTs, indicating favorable efficacy and safety. The Grading of Recommendations Assessment, Development and Evaluation assessment indicated a low level of evidence for CEJ in improving leukocyte elevation efficacy, KPS levels, and myelosuppressive toxicity. Therefore, large-scale, high-quality, rigorous multicenter double-blind controlled trials are recommended to strengthen the evidence level.