Efficacy and safety of AiDi injection in treating primary liver cancer: A systematic review on 70 randomized controlled trials

Background AiDi injection (ADI) has been widely used for primary liver cancer (PLC) and numerous clinical trials in China have been conducted to compare the efficacy of ADI with other treatments for PLC. Objective This study aimed to conduct a systematic review and meta-analysis to comprehensively evaluate ADI for PLC. Methods PubMed, Web of Science, the Cochrane Library, CNKI and WanFang Database were searched to select randomized controlled trials (RCTs) that evaluated ADI for PLC with outcomes including disease control rate (DCR), objective response rate (ORR), quality of life (QoL), serious adverse events (SAEs). The RoB2 tool was used to assess RCTs. Meta-analysis was performed to compute the overall effect sizes using odds ratio (OR) with 95% confidence intervals (CIs). Subgroup and sensitivity analyses, meta-regression, and publication bias were also conducted. The strength of evidence was assessed using with the GRADE method. Results This study included 70 RCTs involving 5283 PLC patients. The overall RoB of RCTs was assessed as some concerns. The effect size of OR was 2.86 (95% CI [2.41, 3.40]) with statistical significance (P < 0.00001) and insignificant heterogeneity (I ²  = 0%, P = 0.69) on DCR. The effect sizes were significant differences (P < 0.00001) with insignificant heterogeneity (P ≥ 0.14) on ORR, QoL, and SAEs. Moreover, subgroup and sensitivity analyses, and meta-regression showed consistent results. Most publication bias analyses showed insignificant differences. The evidence strength was rated as moderate. Conclusion ADI combination therapy demonstrated significant efficacy and safety in PLC patients. Nevertheless, further strong evidence through more high-quality RCTs is warranted to support findings.